Evidence and consensus-based clinical practice guidelines for management of overweight and obesity in midlife women: An AIIMS-DST initiative

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Title: Evidence and consensus-based clinical practice guidelines for management of overweight and obesity in midlife women: An AIIMS-DST initiative
Authors: Piyush Ranjan, Naval K Vikram, Archana Kumari, Sakshi Chopra, Ambuja Choranur, Yashodhara Pradeep, Manju Puri, Anita Malhotra, Maninder Ahuja, Meeta, Achla Batra, Geetha Balsarkar, Deepti Goswami, Kiran Guleria, Siddharth Sarkar, Garima Kachhawa, Aditi Verma, M Krishna Kumari, Jagmeet Madan, Anjali Dabral, Sandhya Kamath, Asmita Muthal Rathore, Raman Kumar, Srikumar Venkataraman, Gaurishankar Kaloiya, Neerja Bhatla, S Shantha Kumari, Upendra Baitha, Anupam Prakash, Mangesh Tiwaskar, Kamlesh Tewary, Anoop Misra, Randeep Guleria
Source: Journal of Family Medicine and Primary Care, Vol 11, Iss 12, Pp 7549-7601 (2022)
Publisher Information: Wolters Kluwer Medknow Publications, 2022.
Publication Year: 2022
Collection: LCC:Medicine
Subject Terms: Medicine
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2249-4863
Relation: http://www.jfmpc.com/article.asp?issn=2249-4863;year=2022;volume=11;issue=12;spage=7549;epage=7601;aulast=Ranjan; https://doaj.org/toc/2249-4863
DOI: 10.4103/jfmpc.jfmpc_51_22
Access URL: https://doaj.org/article/663e2ccfeaa041f5b20b519de7f94cfe
Accession Number: edsdoj.663e2ccfeaa041f5b20b519de7f94cfe
Database: Directory of Open Access Journals
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  Value: <anid>AN0161723669;[fnn4]01dec.22;2023Feb08.05:26;v2.2.500</anid> <title id="AN0161723669-1">Evidence and consensus-based clinical practice guidelines for management of overweight and obesity in midlife women: An AIIMS-DST initiative </title> <p>Introduction</p> <p>Obesity is a clinical and public health epidemic. In most populations, women contribute more to the prevalence of obesity in adults than their male counterparts. The biopsychosocial changes experienced during various stages of the reproductive cycle might implicate excessive weight gain in women.[[<reflink idref="bib1" id="ref1">1</reflink>]] One such high-risk reproductive stage for gaining weight is the menopause transition experienced during midlife. In addition to biological transition, midlife women experience changes in their everyday lifestyle-related habits in a way that might promote unhealthy eating habits, sedentary lifestyles, and distress in the face of household and work responsibilities.[[<reflink idref="bib2" id="ref2">2</reflink>]] Further, weight gain promotes menopausal symptom severity, making it difficult to maintain healthy lifestyle-related behaviours and health-related quality of life.[[<reflink idref="bib3" id="ref3">3</reflink>]]</p> <p>The introduction of corrective lifestyle-related habits has proven beneficial in managing weight and menopausal health.[[<reflink idref="bib4" id="ref4">4</reflink>]] Corrective lifestyle habits such as healthy dietary behaviour, physically active lifestyle, and psychological well-being are necessary for successful weight management. Most midlife women lack the motivation to initiate corrective practices as they prioritise their roles as mothers, homemakers, and workers over their own health. Besides, factors including poor musculoskeletal health, limited physical function, menstrual irregularities, and psychological distress interfere with adopting healthy lifestyle practices.[[<reflink idref="bib5" id="ref5">5</reflink>]] Considering these factors, it becomes necessary to incorporate strategies to address midlife-specific barriers while managing obesity in this group of women to initiate and sustain weight loss efforts.</p> <p>Generally, midlife women receive generic weight management advice from healthcare professionals.[[<reflink idref="bib6" id="ref6">6</reflink>]] This advice is less actionable, so it rarely contributes towards correcting the existing lifestyle-related behaviours in midlife women. In contrast, comprehensive obesity care also lacks specificity to address issues faced by midlife women in managing weight and overall health. This care can be provided by a team of clinicians such as gynaecologists, physicians, and allied healthcare professionals, including nutritionists and exercise physiologists. The availability of such a team in the healthcare setting might be limited, especially in developing countries.[[<reflink idref="bib7" id="ref7">7</reflink>]] This underscores the need for the development of evidence and consensus-based recommendations related to diet, physical activity, and behaviour, which can be used by clinicians and/or any other healthcare provider for opportunistic management of overweight and obesity in midlife women.</p> <p>Methods</p> <p>The development and validation of the guideline were initiated to address the need for protocolised weight management measures specific to midlife women that can be implemented in day-to-day clinical practice at different healthcare settings. The guidelines were developed in two phases using standardised methodology as per the National Health and Medical Research Council (NHMRC): (i) development of recommendations and (ii) validation of the developed recommendations. Firstly, an exhaustive list of key clinical questions through literature search, expert opinion, and Delphi method was identified to be addressed by the guideline. In Phase I, a systematic review of the evidence, grading, and expert opinion were undertaken to formulate clinical practice recommendations for each clinical question. In Phase II, the clinical practice recommendations were peer-reviewed and validated using the Delphi method and graded using the GRADE approach via the experts participating in the Guideline Development Group (GDG).</p> <p>Guideline Development Group (GDG)</p> <p>Expert representatives from multidisciplinary fields including medicine, gynecology, psychology, psychiatry, physical medicine and rehabilitation, nutrition, and exercise physiology were part of the GDG. Further, chairperson and field experts from prominent national organisations such as the Department of Science and Technology, the Federation of Obstetric and Gynaecological Societies of India, Indian Menopause Society, Association of Physicians of India, Academy of Family Physicians of India, Association of Obstetricians & Gynaecologists of Delhi, Indian Dietetic Association, and the Indian Society of Clinical Nutrition also participated in the GDG. From academia, senior professors across five leading medical colleges of the country participated in the proceedings of GDGs. The role and responsibilities of a member of the GDG included finalisation and prioritisation of key clinical questions to be addressed in guideline, review of the available evidence, providing expert opinion, development of the recommendation for each clinical question, validation of the developed recommendations, and grading of the final recommendations.</p> <p>Development and prioritization of key clinical question</p> <p>Initially, a series of exploratory focus group discussions were conducted to identify the risk factors, barriers, and facilitators for appropriate weight management among midlife women.[[<reflink idref="bib8" id="ref8">8</reflink>]] Secondly, a comprehensive, valid and reliable screening tool was designed to evaluate the lifestyle-related practices and barriers faced in maintaining healthy eating, physical activity, and sleep practices. Finally, a cross-sectional survey on 504 midlife women was conducted to identify the daily lifestyle-related patterns and their association with menopausal symptom severity. These steps guided the team in identifying key critical areas that should be addressed for appropriate weight management in midlife women. In addition, an exhaustive literature review was conducted to determine key clinical areas of interest for translation into key clinical questions. Based on the stages of weight management, a comprehensive list of key clinical questions was classified into four domains: (i) initiation of discussion for weight management, (ii) screening and risk assessment of the target population, (iii) management of weight, and (iv) follow-up for weight sustenance. A series of online meetings with GDG were organised to prioritise and finalise the list of key clinical questions that can be addressed in this guideline document. The list of key clinical questions was peer-reviewed for its necessity in clinical practice, relevance, face, and content validity under two levels. At the first level review, key clinical questions were reviewed, modified, and finalised by a group of four to five topic-specific experts. The modified clinical questions were subjected to a second-level peer-review done by a larger group of experts, including experts from different disciplines, journal editors, and senior professors from leading organisations. Finally, 19 key clinical questions were prioritised for appropriate midlife health care.</p> <p>Review of evidence to answer the clinical questions</p> <p>To develop the recommendations, an exhaustive and systematic literature review was conducted independently for each clinical question.</p> <p> <emph>Search for evidence:</emph> A search string was developed for each clinical question. The keywords related to each clinical question were identified through initial literature search, recommendations from experts, and discussion amongst the evidence review team. Three electronic databases (PubMed, Wiley, and Cochrane) were searched to extract relevant evidence.</p> <p> <emph>Selection criteria:</emph> Studies published in peer-reviewed English-language journals and on human participants were selected. Methodological filters related to the study design were not applied at this stage to ensure an extensive and exhaustive search. The evidence team further performed the title, abstract, and full-text screening of articles. Any disagreements on selecting a manuscript were resolved by consensus among the evidence team members.</p> <p> <emph>Eligibility criteria:</emph> </p> <p> <emph>Inclusion Criteria:</emph> Existing practice guidelines, position statement, consensus statement, systematic reviews on weight management and menopausal health and randomised control trials (RCT), experimental and observational studies recruiting midlife women at different menopausal stages, i.e. perimenopause, menopause, or post-menopause were included.</p> <p> <emph>Exclusion Criteria</emph>: Studies reported in non-English language, published in non-peer-reviewed journals, and with limited access were excluded.</p> <p> <emph>Data extraction and synthesis:</emph> The following study characteristics were extracted: year of publication, country, author, study design, sample size, and sample characteristics specific to the clinical question. The findings of the studies were reported in tables to form a write-up for a summary statement.</p> <p>Development of clinical practice recommendations</p> <p>The extracted high-quality data for each clinical question was presented with a summary of evidence supplemented by a narrative table. The evidence was circulated amongst the experts for evaluation to form necessary clinical practice recommendations. Experts were given the training to develop recommendations through online meetings on the following criteria: reviewing evidence, formulating evidence-based recommendations, providing expert opinion, reaching a consensus whenever there is a lack of evidence, and grading the recommendation based on quality. This led to the development of two types of recommendations that is, Recommendations Based on Evidence (RBE) and Recommendations Based on Opinion (RBO). The developed recommendations were subjected to a two-level peer-review process. The first review was conducted by a small group of topic-specific experts, and the second review with a large group of experts, including field experts, academicians and journal editors.</p> <p>GRADE approach</p> <p>The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence profile was constructed to determine the quality of evidence obtained for clinical questions [Table 1] and [Table 2]. Four grades: high, moderate, low, and very low were used to rate the quality of evidence.[[<reflink idref="bib9" id="ref9">9</reflink>]]{Table 1}{Table 2}</p> <p>Results</p> <p>Section I: Initiation of discussion for weight management</p> <p> <emph>1.1 When should a healthcare provider initiate structured counselling regarding weight management in midlife women?</emph> </p> <p>Background</p> <p>The menopausal transition is marked by the onset of irregularity in the menstrual cycle and menopausal symptoms, including hot flushes, physical decline, and emotional volatility.[[<reflink idref="bib2" id="ref10">2</reflink>]],[[<reflink idref="bib10" id="ref11">10</reflink>]] In midlife, chronological ageing coupled with menopausal transition leads to several biological changes predisposing women to weight gain. The independent and interactive contribution of increasing age and menopausal transition remains debatable. Nevertheless, both these factors impact the daily lifestyle behaviours, including eating, activity, and sleep habits of midlife women in a way that might make them prone to excessive weight gain.[[<reflink idref="bib6" id="ref12">6</reflink>]] There is a need to understand at which stage during the menopausal transition should weight gain be identified as a potential detriment to the overall health and quality of life. Identifying these critical phases during midlife can help in the early initiation of weight management support by the healthcare provider.</p> <p>Summary of evidence</p> <p>In India, the mean age of initiation of the menopausal transition is 44 years, whereas 46 years is the mean age at menopause, which is lower than Caucasian women.[[<reflink idref="bib11" id="ref13">11</reflink>]] Similar findings are reported by a systematic review reporting that the age at menopause was 46.24 ± 3.38 years in Indian women.[[<reflink idref="bib12" id="ref14">12</reflink>]] Further, the mean age of early menopause due to premature ovarian insufficiency was 38 years, and late menopause was beyond 54 years. Some studies reported a positive association of menopause with an overall increase in body weight status.[[<reflink idref="bib13" id="ref15">13</reflink>]],[[<reflink idref="bib14" id="ref16">14</reflink>]] However, a direct association of the overall increase in the weight status with hormonal changes during the menopausal transition could not be established. Menopause transition was related to an increase in visceral adiposity.[[<reflink idref="bib15" id="ref17">15</reflink>]],[[<reflink idref="bib16" id="ref18">16</reflink>]] Women experienced a steady increase in weight and body fat during perimenopause and menopausal phases. During the menopausal transition, the accelerated gain in fat mass doubled, whereas a decline in lean muscle mass was observed. The rate of change in the body weight and fat accumulation stabilised before initiation of the post-menopausal phase.[[<reflink idref="bib17" id="ref19">17</reflink>]] Postmenopausal women with overweight and obesity have shown greater circulating estrogen levels than non-obese counterparts. This increase in estrogen is contributed by the peripheral aromatisation of the androgens in adipose tissues. It was previously hypothesised that excessive circulating estrogen levels are beneficial for maintaining menopausal and metabolic health. However, recent studies found out that the increase in estrogen levels is not associated with the protective cardiometabolic effects.[[<reflink idref="bib16" id="ref20">16</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:1]</p> <p>Discussion</p> <p>There is a lack of consistent literature on the independent and interactive nature of chronological ageing and menopausal transition on the weight status of menopausal women. Considering the mean age at menopause as 46 years, it is crucial to engage midlife women in weight regulation before menopausal transition.[[<reflink idref="bib11" id="ref21">11</reflink>]] Ideally, opportunistic screening and management should be delivered across the women's lifespan (as presented in [Table 1.1.1]). Similarly, as per the Anklesaria staging menopausal system, at stage 1 during the perimenopausal phase, the advice should be shared to create awareness and manage obesity and other menopause-related health risks amongst midlife women.[[<reflink idref="bib18" id="ref22">18</reflink>]] In the later 30s, women should be made aware of experiencing a probable increase in their weight and total body fat status with the onset of the menopausal transition. At this phase, the healthcare providers should counsel women regarding the changes in the menstrual cycle and its probable association with weight gain. Because the age at menopause can vary amongst women belonging to different population groups, the experts have given a dual strength of recommendation to this clinical practice. In the late 40s, an opportunistic screening of weight and health status, followed by customised weight management, should be initiated and continued with the aim of achieving normal weight status. The healthcare provider should advise dietary and physical activity modifications using behavioural techniques for managing weight. In addition, other menopause-related health issues, including psychological distress, sarcopenia, and bone health, should also be addressed during weight management. It should be noted that the evidence for the recommendations mentioned above is derived mainly from studies on midlife women in the west. To our knowledge, there are no longitudinal studies that assess the changes in weight status and body composition during the menopausal transition in midlife women from India. The association of menopausal transition (independent of chronological ageing) and weight status needs to be assessed for the engagement of Indian women in weight-management practices. Thus, the recommendations should be revisited and revised every 5 to 10 years in the face of new evidence on the age of menopause in Indian women, changes in body composition during menopausal transition, and effective weight management practices.[INLINE:2]</p> <p> <emph>1.2: What are the components of knowledge, attitude and practice (KAP) that should be evaluated to plan a personalised weight management intervention in midlife women?</emph> </p> <p>Background</p> <p>The successful management of obesity and other lifestyle-related disorders depends on adopting behavioural techniques for correcting eating, activity, and other lifestyle-related habits.[[<reflink idref="bib19" id="ref23">19</reflink>]] The behavioural practices are motivated by pre-existing knowledge and attitude of an individual. In the literature, knowledge is defined as information and skills acquired using experience and education. Attitude is a value, belief, and feeling that predisposes an individual towards a particular behaviour and behavioural practices are habits and patterns associated with the maintenance of weight status.[[<reflink idref="bib20" id="ref24">20</reflink>]],[[<reflink idref="bib21" id="ref25">21</reflink>]] KAP assessment is common in lifestyle-related diseases in clinical and community settings.[[<reflink idref="bib22" id="ref26">22</reflink>]] The clinician needs to understand the KAP of midlife women that promotes obesity. The KAP of core components associated with obesity in midlife women should include lifestyle practices, menopausal symptoms, bone health, and psychological distress.[[<reflink idref="bib2" id="ref27">2</reflink>]] Generally, the KAP can be assessed before the initiation of lifestyle management to identify the risk factors specific to middle-aged women that the clinician should attempt to modify during weight management. A few qualitative studies and cross-sectional surveys have independently assessed KAP for different obesity-related factors in midlife women.[[<reflink idref="bib23" id="ref28">23</reflink>]],[[<reflink idref="bib24" id="ref29">24</reflink>]],[[<reflink idref="bib25" id="ref30">25</reflink>]] In qualitative studies, the influence of social, cultural, and economic constructs on obesity-related behaviours has been highlighted. Across cross-sectional studies, KAP was assessed using self-developed or validated questionnaires that rate an individual's competence in the three domains and correlate with weight and metabolic status.[[<reflink idref="bib26" id="ref31">26</reflink>]],[[<reflink idref="bib27" id="ref32">27</reflink>]],[[<reflink idref="bib28" id="ref33">28</reflink>]] A comprehensive assessment of KAP on lifestyle practices, menopausal symptoms, bone health, and psychological distress as risk factors for obesity in midlife is lacking in the current literature. Hence, this clinical question addressed the present evidence on KAP of critical components associated with the management of obesity in midlife women to deliver women-centric management of obesity.</p> <p>Summary of evidence</p> <p>The critical components evaluated for the initiation of management of obesity in midlife women included: weight and health-related measures, menopausal symptoms, bone health and psychological distress. The KAP of these components is considered necessary for customising the weight management regime for a midlife woman.[[<reflink idref="bib24" id="ref34">24</reflink>]],[[<reflink idref="bib28" id="ref35">28</reflink>]],[[<reflink idref="bib29" id="ref36">29</reflink>]],[[<reflink idref="bib30" id="ref37">30</reflink>]] For weight and lifestyle-related parameters, women reported a lack of knowledge regarding corrective weight-related practices, lack of time, social eating, indulging in high-fat, sugar, and salt foods (HFSS), and reduced daily activity, led to obesity.[[<reflink idref="bib31" id="ref38">31</reflink>]],[[<reflink idref="bib32" id="ref39">32</reflink>]] Four studies reported the interplay between the menopausal symptoms severity and psychological distress, leading to the consumption of energy-dense foods and limited physical activity in midlife women. The difficulty in sleeping due to hot flashes and mood disorders was associated with weight gain in midlife women.[[<reflink idref="bib33" id="ref40">33</reflink>]],[[<reflink idref="bib34" id="ref41">34</reflink>]],[[<reflink idref="bib35" id="ref42">35</reflink>]] Menopause led joint pain was the primary reason for limited participation in dedicated physical activity. Moreover, women had limited knowledge regarding age-related osteoporosis and measures that can be taken to maintain bone health such as getting a regular bone check-up, consuming foods rich in calcium, and consulting doctors for guidance on supplementation such as vitamin D and calcium for bone health.[[<reflink idref="bib27" id="ref43">27</reflink>]],[[<reflink idref="bib30" id="ref44">30</reflink>]] In addition to limited knowledge, most women prioritised their roles as homemakers, working women and child care providers over their own health issues.[[<reflink idref="bib36" id="ref45">36</reflink>]],[[<reflink idref="bib37" id="ref46">37</reflink>]] This self-sacrificing attitude coupled with limited support from family and friends in maintaining health-related behaviours in their day-to-day lifestyle should also be addressed for maintaining continuous and sustainable efforts for weight management and allied comorbidities.[[<reflink idref="bib24" id="ref47">24</reflink>]],[[<reflink idref="bib36" id="ref48">36</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:3]</p> <p>Discussion</p> <p>A comprehensive assessment of KAP should be done to identify key areas that the interventionist should attempt to modify during lifestyle intervention to achieve clinically significant weight loss. The recommendations were based on well-known, lifestyle and midlife-related risk factors experienced during the menopausal transition. However, the evidence was from independent studies on a particular risk factor (e.g., diet, mental health, joint health etc.). There were no data on a comprehensive assessment of KAP related to risk factors of obesity in midlife women, which would be relevant to guide future clinical and research practice. Besides, the effectiveness of KAP in providing customised weight management advice for achieving significant weight loss should be assessed using longitudinal studies or RCTs in future research. Considering the importance of KAP in customising weight management approaches in midlife women, experts agreed that a comprehensive assessment of KAP as a component of risk assessment of obesity in midlife women should be incorporated into clinical practice (shown in [Table 1.2.1]). Based on available resources in the healthcare or community setting, healthcare professionals can assess KAP via history taking, group discussions and/or interview schedule with a structured questionnaire. The key questions that can be assessed in resource-constrained settings are presented in [Table 1.2.2].</p> <p>[INLINE:4]</p> <p>[INLINE:5]</p> <p> <emph>1.3 Which healthcare providers can be involved in the management of overweight and obesity in midlife women?</emph> </p> <p>Background</p> <p>Obesity is a complex and multisystem disorder.[[<reflink idref="bib38" id="ref49">38</reflink>]] According to the international guidelines, preventive and curative obesity treatment should be delivered to individuals across the healthcare system.[[<reflink idref="bib39" id="ref50">39</reflink>]] The comprehensive treatment of obesity and allied complications requires a multicomponent and multidisciplinary approach. A multidisciplinary approach manages treatment components with the help of different healthcare professionals including a primary care physician, family physician and/or a gynaecologist with expertise in pharmacotherapy, an exercise physiologist, a dietitian, and a psychologist to provide comprehensive weight management counselling.[[<reflink idref="bib40" id="ref51">40</reflink>]] Despite the consensus on promoting multicomponent and multidisciplinary approaches amongst obesity experts, there are no specific guidelines or position statements on the operationalisation of these treatment modalities in daily clinical practice.[[<reflink idref="bib41" id="ref52">41</reflink>]] The limited application of multidisciplinary approaches can be due to limited healthcare resources such as a low doctor-to-patient ratio, time constraints, lack of auxiliary healthcare teams, and infrastructure, especially in developing countries.[[<reflink idref="bib42" id="ref53">42</reflink>]] Considering the challenges in the management of obesity in healthcare settings, it becomes essential to identify the roles and responsibilities of clinicians and allied healthcare professionals that can make multidisciplinary teams. Furthermore, these teams should be educated and trained to equip healthcare professionals to assess obesity risk, provide brief weight counselling advice, and referrals specialists at healthcare centres.[[<reflink idref="bib43" id="ref54">43</reflink>]]</p> <p>Summary of evidence</p> <p>The comprehensive management of overweight and obesity includes three key components: diet, physical activity and behavioural strategies. In 29 pertinent weight-loss trials, the treatment modalities were managed by either a multidisciplinary team, a core team of two healthcare professionals or single-handedly by a dietitian. In seven studies, a qualified dietitian provided lifestyle counselling to the participants to manage their weight.[[<reflink idref="bib44" id="ref55">44</reflink>]],[[<reflink idref="bib45" id="ref56">45</reflink>]],[[<reflink idref="bib46" id="ref57">46</reflink>]] As per 11 studies, weight management teams commonly consist of two healthcare professionals from different specialities. Out of 11 studies, nine studies opted for a team of dietitians and exercise experts such as physiotherapists, exercise physiologists, exercise specialists or personal trainers for weight management.[[<reflink idref="bib47" id="ref58">47</reflink>]],[[<reflink idref="bib48" id="ref59">48</reflink>]],[[<reflink idref="bib49" id="ref60">49</reflink>]] In three studies, lifestyle advice was coupled with behavioural techniques counselled by a team of dietitians and behaviour management experts such as psychologists, behaviour science experts or clinical health psychologists.[[<reflink idref="bib50" id="ref61">50</reflink>]],[[<reflink idref="bib51" id="ref62">51</reflink>]],[[<reflink idref="bib52" id="ref63">52</reflink>]] It was observed that dietitians are an essential component of all the core teams. Nine studies reported that a multidisciplinary team consisting of a dietitian, exercise physiologist, and behavioural therapist were a part of a comprehensive weight management program.[[<reflink idref="bib53" id="ref64">53</reflink>]],[[<reflink idref="bib54" id="ref65">54</reflink>]],[[<reflink idref="bib55" id="ref66">55</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:6]</p> <p>Discussion</p> <p>The effective management of weight in healthcare settings requires a multidisciplinary team. Despite the importance of multidisciplinary teams, the onus of effective preventive and curative obesity care lies on all the healthcare professionals who encounter midlife women with overweight and obesity. Often, midlife women meet primary care physicians and family physicians as the first point of contact in the healthcare system. The incorporation of family care physicians as a part of the core weight management team or an extended weight management team is vital for initiating effective management at the healthcare level. In literature, dietitians-led weight management was most commonly observed across weight-loss trials. The inclusion of dietitians in core weight management teams and/or frequent referrals to dietitians can be helpful to impart detailed lifestyle modification counselling that might not be feasible for a general practitioner or gynaecologist in a busy outpatient setting. Experts believe further attempts can be made based on the available healthcare resources to involve specialists and clinicians such as exercise physiologists, psychologists, and orthopaedics who have decisive roles in obesity management in midlife women. Considering the limited healthcare resources in developing countries such as India, a dedicated multidisciplinary approach can be limited to established tertiary healthcare set-ups. Experts suggest that interprofessional education and training sessions to discuss professional attitudes, skills and barriers faced in everyday clinical practice for obesity management can be the first step to mitigate this resource constraint. Every healthcare provider should be trained in opportunistic screening and generalised management of obesity in midlife women.</p> <p> <emph>1.4: What could be the effective ways of delivering pertinent information to midlife women regarding the management of overweight and obesity?</emph> </p> <p>Background</p> <p>Health promotion counselling is a feasible, cost-effective and long-term solution for the effective management of obesity. The National Health and Medical Research Council (NHMRC) (2013) recommendations refer to the importance of health promotion and lifestyle advice to identify, assist and treat individuals with obesity.[[<reflink idref="bib56" id="ref67">56</reflink>]] The lifestyle counselling paradigm has evolved over the years from personalised counselling sessions to web-based interventions.[[<reflink idref="bib57" id="ref68">57</reflink>]],[[<reflink idref="bib58" id="ref69">58</reflink>]] Personalised counselling can be defined as one-to-one counselling sessions with trained healthcare providers focused on managing an individual's weight-related issues.[[<reflink idref="bib59" id="ref70">59</reflink>]] Group counselling provides an opportunity to discuss and share similar weight-related concerns amongst a group of participants in the presence of trained healthcare professionals in a real social setting.[[<reflink idref="bib60" id="ref71">60</reflink>]] In the current clinical practice, the traditional one-to-one counselling is supplemented with web-based interventions that help in improving compliance to the lifestyle advice by providing personalised feedback and addressing challenges in real-time.[[<reflink idref="bib61" id="ref72">61</reflink>]] Web-based counselling utilises technological components such as the internet, mobile application and online social support groups to counsel women on weight-related issues.[[<reflink idref="bib62" id="ref73">62</reflink>]] Nowadays, web-based counselling techniques have replaced the non-digital formats for nutrition education consisting of patient education material such as pamphlets, brochures, and e-newsletters. However, there is limited evidence on the mode of lifestyle counselling (independent or in combination) that will effectively manage weight in midlife women. Further, healthcare professionals need to understand the most effective and promising way of delivering information for counselling on weight management components (diet, physical activity and behaviour) for widespread acceptance of advice. To date, the role of different counselling techniques and modalities of communication in improving odds of achieving successful weight loss and prevention of weight gain remains unclear. Hence, this clinical question was undertaken to identify the most promising ways of counselling and delivery of patient education advice for effective management of obesity in clinical and community settings.</p> <p>Summary of evidence</p> <p>The pertinent studies identified used a range of counselling techniques, including personalised counselling sessions, group counselling, telephonic counselling sessions, or a combination to achieve significant weight loss. A systematic review comparing the role of group and individualised counselling for weight management reported that group counselling led by a psychologist was more effective for female participants.[[<reflink idref="bib63" id="ref74">63</reflink>]] It was also reported that in-person and more frequent contact were not associated with more significant weight loss.[[<reflink idref="bib64" id="ref75">64</reflink>]] In addition to these techniques, web-based counselling sessions were also opted for weight management. Four meta-analysis and systematic reviews assessed the role of technology-based interventions suggesting different web-based interventions were minimally effective in weight management. In comparison to traditional personalised counselling techniques, the efficacy of the web-based intervention was inconsistent.[[<reflink idref="bib65" id="ref76">65</reflink>]] A recent systematic review suggested that web-supported video conferencing sessions are effective in maintaining physical activity.[[<reflink idref="bib58" id="ref77">58</reflink>]]</p> <p>In addition to counselling, various forms of nutrition education material have been used across trials to facilitate weight loss. Education material such as printed material, exercise videos and mobile application for self-monitoring is available.[[<reflink idref="bib44" id="ref78">44</reflink>]],[[<reflink idref="bib66" id="ref79">66</reflink>]],[[<reflink idref="bib67" id="ref80">67</reflink>]] A systematic review has reported that dietary counselling was mostly given as verbal advice coupled with handouts/brochures. There were no referrals for comprehensive weight management to the dietitians. Three-fourth of the participants were advised to walk for physical activity without providing any tailor-made activity plan.[[<reflink idref="bib68" id="ref81">68</reflink>]] It was suggested that a toolkit approach should be undertaken, including evidence-based and practical dietary, physical activity, and behavioural advice.</p> <p>Clinical practice recommendations</p> <p>[INLINE:7]</p> <p>Discussion</p> <p>A combined counselling regime consisting of individualised and internet-based distance counselling sessions can help to improve the odds of achieving weight loss success in the general population and midlife women. Experts believed that healthcare providers should decide the mode of counselling based on several factors, including infrastructure, availability of resources, the expertise of the healthcare provider, clinician to patient ratio, and characteristics of the patient attending healthcare settings. It is important to note the advantages and disadvantages of each counselling method, education tools to customise the weight management approach (as depicted in [Table 1.4.1] and [Table 1.4.2]). The experts recommended a uniform toolkit approach to provide nutrition, physical activity and behavioural strategies for management of weight in midlife women across health care settings. This toolkit should include health education material that can be easily used for counselling by allied healthcare professionals, especially in rural settings. Currently, social media has been identified as an upcoming cost-effective tool for increasing patient engagement, health promotion and social support at an individual and community level.[[<reflink idref="bib69" id="ref82">69</reflink>]]</p> <p>[INLINE:8]</p> <p>[INLINE:9]</p> <p>Section II: Screening and risk assessment of midlife women</p> <p> <emph>2.1: What BMI cut-off and other anthropometric parameters should determine the need to initiate weight management intervention in midlife women?</emph> </p> <p>Background</p> <p>Body mass index (BMI) is a universally accepted method for diagnosing overweight and obesity.[[<reflink idref="bib70" id="ref83">70</reflink>]] BMI is an index of weight and height, expressed as kg/m<sups>2</sups>. Ideally, BMI is used as a measure of adiposity. The internationally accepted BMI cut-offs and corresponding components of body weight (body fat, muscle mass and total water) are known to vary in different ethnic communities.[[<reflink idref="bib71" id="ref84">71</reflink>]] Because the internationally accepted BMI cut-offs are based on data from the western population, ethnic variation in BMI cut-offs for Asian Indians should be addressed. In addition to BMI, other anthropometric parameters such as waist and hip circumference and their ratios such as waist to height ratio (WHtR) and waist to hip ratio (WHR) can be used for the assessment of generalised and central obesity. Waist circumference and its ratios are important anthropometric parameters associated with visceral adiposity and cardiometabolic health.[[<reflink idref="bib72" id="ref85">72</reflink>]] In resource-rich settings, methods such as Bioelectric Impedence Analysis (BIA) and Dual X-ray Absorptiometry (DEXA) can be used for objective assessment of total body fat, skeletal and lean muscle mass.[[<reflink idref="bib73" id="ref86">73</reflink>]] The choice of anthropometric measure opted for diagnosis is dependent on several factors including technical know-how, availability of instruments, healthcare personnel, infrastructure, and the clinician to patient ratio. It is important to identify anthropometric parameters, which are simple, feasible, cost-effective and efficacious in identifying generalised and central obesity status in clinical practice.</p> <p>Summary of evidence</p> <p>The optimum BMI coupled with waist circumference cut-off has been identified across the literature to diagnose overweight and obesity. Globally, for the categorization of BMI, World Health Organisation (WHO) suggests an individual with a cut-off of 25–29.9 kg/m<sups>2</sups> as overweight and ≥ 30 kg/m<sups>2</sups> as obese. It was identified that the globally recommended cut-off for defining overweight and obesity should be lowered in different Asian population groups due to ethnic variation in the total body fat and fat-free mass. The Indian Consensus Group (2009) recommended a cut-off value of 23–24.9 kg/m<sups>2</sups> as an indicator of overweight individuals and ≥25 kg/m<sups>2</sups> as an indicator for obese individuals.[[<reflink idref="bib74" id="ref87">74</reflink>]] Across literature on lifestyle modification in menopausal women, the BMI range was 23–45 kg/m<sups>2</sups>.[[<reflink idref="bib75" id="ref88">75</reflink>]],[[<reflink idref="bib76" id="ref89">76</reflink>]],[[<reflink idref="bib77" id="ref90">77</reflink>]]</p> <p>In addition to BMI, the consensus statement from a working group reported that waist circumference should be made a vital sign for clinical assessment.[[<reflink idref="bib72" id="ref91">72</reflink>]] According to the WHO, women with waist circumference > 88 cm can be at risk of at least one cardiometabolic risk factor.[[<reflink idref="bib78" id="ref92">78</reflink>]] For Asian Indians, a woman > 80 cm waist circumference should seek help from a healthcare practitioner for management of obesity-related risk factors and women with waist circumference > 72 cm should avoid gaining weight and incorporate physical activity to avoid having any cardiometabolic risk factor in later life.[[<reflink idref="bib74" id="ref93">74</reflink>]] We found six trials that assessed the waist circumference at the baseline. Out of which, four studies defined the waist circumference cut-off as 80 cm and two studies defined waist circumference cut-off as 88 cm.[[<reflink idref="bib79" id="ref94">79</reflink>]],[[<reflink idref="bib80" id="ref95">80</reflink>]],[[<reflink idref="bib81" id="ref96">81</reflink>]],[[<reflink idref="bib82" id="ref97">82</reflink>]] We found three studies assessing baseline total body fat for midlife women enrolling in lifestyle modification intervention, with a cut-off of more than 32% in one study[[<reflink idref="bib83" id="ref98">83</reflink>]] and more than 35% in one RCT and systematic review. Only four studies assessed the total body fat percentage at the baseline in midlife women undergoing weight loss intervention.[[<reflink idref="bib75" id="ref99">75</reflink>]],[[<reflink idref="bib79" id="ref100">79</reflink>]],[[<reflink idref="bib83" id="ref101">83</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:10]</p> <p>Discussion</p> <p>We found robust evidence that suggests that BMI and waist circumference are associated with risk of general and abdominal adiposity, cardiometabolic risk and obesity-related diseases. The universally recommended BMI values for overweight (≥ 25 kg/m<sups>2</sups>) and obesity (≥ 30 kg/m<sups>2</sups>) were established on the basis of morbidity and mortality data from the white adult population.[[<reflink idref="bib70" id="ref102">70</reflink>]] In Asian Indians, higher body fat and higher cardiometabolic comorbidities are observed at a lower BMI status.[[<reflink idref="bib84" id="ref103">84</reflink>]] This raises concerns in clinical practice as these individuals who are metabolically obese and predisposed to developing hyperlipidaemia, diabetes, blood pressure and atherosclerosis are misclassified as individuals with normal BMI. Considering a greater cardiometabolic risk at a lower BMI, a revision of the BMI cut-off for Asian Indians was suggested by national recommendation bodies as 23–24.9 kg/m<sups>2</sups> for overweight and 25 kg/m<sups>2</sups> or more as obese. It should be noted that clinicians and healthcare providers should classify midlife women according to the Asian Indian specifications in their daily clinical practice, rather than the internationally accepted guidelines.</p> <p>In addition to BMI, waist circumference should be utilised in the assessment of generalised and abdominal obesity, especially to identify women who are metabolically obese presenting with normal weight (MONW) in clinical settings. These anthropometric parameters can be used to screen women at high risk of cardiometabolic disease and obesity-related disorders for timely initiation of treatment. Considering the importance of waist circumference in assessing cardiometabolic risk factors in an individual, a consensus on cut-offs of waist circumference in the adult population was recommended. For women, a waist circumference of more than 88 cm was considered as an indicator of cardiometabolic risk.[[<reflink idref="bib78" id="ref104">78</reflink>]],[[<reflink idref="bib85" id="ref105">85</reflink>]] In Asian women, a waist circumference of 80 cm was considered appropriate in identifying cardiovascular risk factors in comparison to 88 cm, which was internationally accepted.[[<reflink idref="bib74" id="ref106">74</reflink>]] Furthermore, ratios such as WtHR and WHR are used as an indicator of metabolic health. Evidence suggests that waist circumference alone is a vital responsive clinical sign of cardiometabolic health in comparison to WHR.[[<reflink idref="bib72" id="ref107">72</reflink>]]</p> <p>Experts suggested that measurement of anthropometric parameters BMI and waist circumference should be made a part of routine clinical practice as a vital clinical sign for health assessment of midlife women.</p> <p>In addition, clinicians should also stratify treatment at different BMI cut-offs for optimal utilization of resources for diagnosis and treatment. The intensity of weight management advice should be in accordance with deviation from the ideal weight and waist circumference. The use of pharmacotherapy should be incorporated in the treatment only as per indications by the treating clinician. In addition to cut-offs, the availability of resources should also be noted while planning obesity care, especially in resource-constrained settings such as anganwadi, community clinics and primary healthcare centres (PHC).</p> <p> <emph>2.2: How should dietary practices of midlife women be evaluated?</emph> </p> <p>Background</p> <p>The assessment of lifestyle-related risk factors is an important step in managing weight in midlife women. In clinical practice, a detailed dietary history consisting of current caloric intake, adequacy of macronutrient composition (<emph>carbohydrate, protein and fat</emph>), consumption of HFSS foods, meal pattern, portion size, eating out, and nutritional deficiencies is a common method of dietary assessment.[[<reflink idref="bib86" id="ref108">86</reflink>]] For an objective assessment in terms of quantity and quality, traditional methods such as twenty-four-hour recall and food frequency questionnaires (FFQ) can be administered by trained healthcare professionals.[[<reflink idref="bib87" id="ref109">87</reflink>]] In addition, most weight-loss trials administered valid and reliable questionnaires to assess different aspects of eating behaviour.[[<reflink idref="bib45" id="ref110">45</reflink>]],[[<reflink idref="bib88" id="ref111">88</reflink>]],[[<reflink idref="bib89" id="ref112">89</reflink>]],[[<reflink idref="bib90" id="ref113">90</reflink>]] The choice of the assessment method depends on a number of factors such as the aim of assessment, the expertise of the healthcare provider, availability of time, participant burden, infrastructure and method of interpretation of collected information. It is commonly observed that a majority of clinicians are involved in general dietary management as a part of midlife care.[[<reflink idref="bib2" id="ref114">2</reflink>]] It becomes important to identify simple, practical and cost-effective ways for dietary assessment, which can facilitate holistic dietary counselling, especially in resource-constrained settings with limited or no availability of a nutritionist or a dietitian.</p> <p>Summary of evidence</p> <p>A total of 15 instruments were identified for dietary assessment of the individuals participating in weight-loss interventions. Only one study assessed the dietary quality using the healthy eating index (HEI)-2010.[[<reflink idref="bib91" id="ref115">91</reflink>]] The usual dietary intake of the participants was most commonly assessed at baseline in weight loss trials. A total of nine studies assessed usual dietary intake by administering 24-hour dietary recall (three weekdays and one weekend)[[<reflink idref="bib92" id="ref116">92</reflink>]] Women's Health Initiative FFQ,[[<reflink idref="bib89" id="ref117">89</reflink>]] Vioscreen (an electronic FFQ),[[<reflink idref="bib44" id="ref118">44</reflink>]] four-day food record [[<reflink idref="bib48" id="ref119">48</reflink>]] and dietary food logs.[[<reflink idref="bib83" id="ref120">83</reflink>]] The frequency, type and distribution of meals were assessed via a meal pattern assessment grid in two studies.[[<reflink idref="bib49" id="ref121">49</reflink>]],[[<reflink idref="bib89" id="ref122">89</reflink>]] The frequency of intake of HFSS foods was assessed using two scales including fat-related intake questionnaires,[[<reflink idref="bib93" id="ref123">93</reflink>]] and Connor Diet Habit Survey.[[<reflink idref="bib94" id="ref124">94</reflink>]] The eating behaviour was assessed via a 51-item valid and reliable Three-Factor Eating Behavior Questionnaire(TFEQ) measuring three domains: Cognitive Restraint, Disinhibition, and Hunger on a four-point Likert scale.[[<reflink idref="bib88" id="ref125">88</reflink>]],[[<reflink idref="bib95" id="ref126">95</reflink>]],[[<reflink idref="bib96" id="ref127">96</reflink>]] Only two studies measured the barriers faced in maintaining healthy eating in an interview schedule to assess the factors such as emotional eating, daily mechanics of healthy eating and lack of social support on a five-point Likert scale.[[<reflink idref="bib97" id="ref128">97</reflink>]],[[<reflink idref="bib98" id="ref129">98</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:11]</p> <p>Discussion</p> <p>The recommendations were based on guidelines, position statements and RCTs in the general population and midlife women for the management of overweight and obesity. The evidence suggests that assessment of current caloric intake, dietary habits related to health risks (such as sarcopenic obesity, cardiometabolic distress, osteoarthritis), and micronutrient deficiencies is a crucial step in the dietary management for weight loss in midlife women.[[<reflink idref="bib99" id="ref130">99</reflink>]],[[<reflink idref="bib100" id="ref131">100</reflink>]] Ideally, midlife women should be referred to dietitians and/or nutritionists to assess current dietary intake using a 24-h dietary recall method coupled with FFQ. For clinicians and researchers interested in utilizing traditional tools for dietary assessment, a detailed description of available tools with their advantages and disadvantages is presented in [Table 2.2.1]. However, these methods suffer from practical limitations such as the need for technical knowledge, are time-consuming, and are difficult to interpret, especially in resource-constrained settings. Experts believed that a detailed dietary history should be considered a simple, practical and feasible assessment method in daily clinical practice. For ease of practice, the details on specific points to be considered while taking the dietary history are presented in [Table 2.2.2]. Considering the resource availability, practitioners can opt for a combination of methods for dietary assessment that can provide them with complete information on current dietary practices in midlife women. Special attention should be given to assessing the regular consumption of foods rich in protein, iron, and calcium. Healthcare practitioners can assess the intake of foods rich in protein and other micronutrients in two ways: (i) quantitatively via 24-h dietary recall method or a semi-quantitative FFQ and/or (ii) qualitatively via dietary history. In the presence of any clinical symptoms related to micronutrient deficiencies, a detailed clinical history, assessment of clinical signs and confirmatory laboratory tests (if feasible) should be planned under the guidance of a clinician. Diet diversity can also be checked via an easy to administer checklist like the FIGO Nutrition checklist consisting of six questions on consumption of food groups to assess the dietary quality. This checklist can be completed before the doctor's appointment at the outpatient setting.[[<reflink idref="bib101" id="ref132">101</reflink>]] This checklist can be customised and validated for Indian midlife women.</p> <p>[INLINE:12]</p> <p>[INLINE:13]</p> <p>Midlife women presenting with signs and symptoms of iron deficiency anaemia can be assessed through (i) examination of clinical signs and symptoms like pallor of eyelids, tongue, nail beds and palms and (ii) prescribing a complete blood count including assessment of haemoglobin (Hb), mean corpuscular haemoglobin (MCH), mean cell haemoglobin concentration (MCHC), and mean corpuscular volume (MCV) as a preliminary predictive test.[[<reflink idref="bib102" id="ref133">102</reflink>]] The blood level of serum ferritin is considered the most appropriate test for assessing iron deficiency anaemia.[[<reflink idref="bib103" id="ref134">103</reflink>]] The cut-off values for the assessment of iron deficiency anaemia are given in [annexure 1].</p> <p>There are no reliable biochemical status markers for the assessment of calcium deficiency in adults.[[<reflink idref="bib104" id="ref135">104</reflink>]] In a resource-constrained setting with limited possibilities of performing a 24-hour recall for assessment of calcium intake, the daily dietary calcium intake can be assessed using a feasible National Osteoporosis Foundation (NOF) tool (as shown in Annexure 2).[[<reflink idref="bib105" id="ref136">105</reflink>]] The adequacy of calcium intake can be assessed by comparing the calculated daily dietary calcium intake with the recommended daily allowance (RDA). In addition, Vitamin D deficiency can be assessed by testing the serum 25-hydroxyvitamin D concentrations, especially in midlife women presenting with joint and bone-related issues.[[<reflink idref="bib104" id="ref137">104</reflink>]] The cut-offs for the assessment of vitamin D deficiency in adults are presented in Annexure 3.[[<reflink idref="bib106" id="ref138">106</reflink>]]</p> <p>The final step in dietary assessment is to ascertain the barriers faced by midlife women in managing healthy eating practices in their day-to-day life. These barriers should be considered for providing personlised dietary modification advice. A valid and reliable questionnaire for assessing dietary practices and barriers to healthy eating in Indian midlife women can be accessed from [Annexure 4].</p> <p> <emph>2.3: How should the level of daily physical activity of midlife women be evaluated?</emph> </p> <p>Background</p> <p>The assessment of daily physical activity status is important for determining the total caloric deficit required for achieving weight loss in midlife women. Daily activity assessment is aimed at calculating caloric expenditure. Daily physical activity can be comprehensively assessed under the following domains: exercise, occupational, household-related, leisure-related and sedentary activities.[[<reflink idref="bib107" id="ref139">107</reflink>]] Physical activity is defined as 'bodily movement generated due to contraction of the muscle that raises the energy expenditure above resting metabolic equivalents (METs)'. It is generally characterised by type, intensity, and duration. Exercise is a sub-category of activity that is planned, structured and repeated for maintaining physical fitness.[[<reflink idref="bib108" id="ref140">108</reflink>]] Sedentary activities are defined as "any activity with an energy expenditure of ≤ 1.5 metabolic equivalents (METs) while in a sitting, reclining and lying posture".[[<reflink idref="bib109" id="ref141">109</reflink>]] Several methods have been used for objective assessment (accelerometers, heart rate monitors, mobile applications) and subjective assessment (detailed activity history, physical activity questionnaires and activity monitoring applications).[[<reflink idref="bib51" id="ref142">51</reflink>]],[[<reflink idref="bib110" id="ref143">110</reflink>]],[[<reflink idref="bib111" id="ref144">111</reflink>]],[[<reflink idref="bib112" id="ref145">112</reflink>]],[[<reflink idref="bib113" id="ref146">113</reflink>]] The choice of assessment method in healthcare settings depends on efficacy and ease of use with respect to available time, expertise, and economics. In most healthcare settings, clinicians primarily engage midlife women in considering an active lifestyle. It is important to identify concise, valid and reliable assessment methods that can be taken up by the clinicians and other healthcare professionals for a time-bound and comprehensive assessment of daily physical activity.</p> <p>Summary of evidence</p> <p>Across weight-loss trials, daily physical activity was assessed using objective, subjective and a combination of both measures. Objective measures included an accelerometer and pedometer worn on the wrist, waist or hip to calculate the mean physical activity as MET values.[[<reflink idref="bib90" id="ref147">90</reflink>]],[[<reflink idref="bib111" id="ref148">111</reflink>]],[[<reflink idref="bib112" id="ref149">112</reflink>]] In subjective measures, a total of ten questionnaires were used to assess the total physical activity across different domains such as leisure, occupational, household chores, and sitting and screen time. Five studies assessed physical activity using a combination of objective measures such as accelerometer and subjective measures such as Stanford 7 day Physical Activity Recall, International Physical Activity Questionnaire (IPAQ), and Minnesota Physical Activity Questionnaire.[[<reflink idref="bib110" id="ref150">110</reflink>]],[[<reflink idref="bib114" id="ref151">114</reflink>]],[[<reflink idref="bib115" id="ref152">115</reflink>]] The questionnaires evaluating both sedentariness and activity status are IPAQ and Modifiable Activity Questionnaire <emph>(MAQ</emph>).[[<reflink idref="bib113" id="ref153">113</reflink>]],[[<reflink idref="bib116" id="ref154">116</reflink>]] Other domain-specific activity questionnaires are the Leisure-Time Physical Activity Questionnaire and Allied Dunbar National Fitness Survey for leisure-related physical activity and work and non-work activity by Stanford Physical Activity Recall.[[<reflink idref="bib50" id="ref155">50</reflink>]],[[<reflink idref="bib117" id="ref156">117</reflink>]] Sedentariness was measured using low level physical activity recall and Sitting Questionnaire.[[<reflink idref="bib118" id="ref157">118</reflink>]] The assessment can be reported as continuous scores (mean MET values per day or week) or categorical scores as low, moderate and high activity according to the cut-off MET values per day.</p> <p>It was also observed that physical activity assessment should be done for activities that are specific to geographical, social and cultural constructs. Considering this, the physical activity assessment scale for the western population might not correctly measure the level of physical activity in midlife women in India. MPAQ is a recall measure specifically developed and validated in the Indian population to measure both the level of physical activity in different domains and sedentariness.[[<reflink idref="bib119" id="ref158">119</reflink>]] Although, the application of this measure in a busy outpatient setting is still limited. There is limited evidence on short and comprehensive physical activity assessment tools that can measure the level of physical activity as well as barriers faced by midlife women in managing daily physical activity.</p> <p>Clinical practice recommendations</p> <p>[INLINE:14]</p> <p>Discussion</p> <p>Physical activity assessment should be made a standard step in routine care to design and promote strategies to maintain an active lifestyle.[[<reflink idref="bib120" id="ref159">120</reflink>]] The recommendations on baseline assessment of physical activity status in midlife women are derived from lifestyle modification RCTs aiming at achieving weight loss. The two methods identified for physical activity assessment are objective (activity monitors: accelerometer, pedometer) and subjective methods (questionnaires and activity history). In public health and clinical settings, subjective methods including self-reported PA questionnaires, daily activity logs and activity history schedules are commonly used to assess the level of daily activities. There is evidence that comprehensive assessment of daily activities across domains including physical activity, household chores, work, transport and sedentary activities is crucial to assess the total daily caloric expenditure.[[<reflink idref="bib80" id="ref160">80</reflink>]] Experts believed that healthcare practitioners should consider the feasibility of the assessment approach before including it in daily clinical practice. Based on resource availability, the assessment can be done using three possible methods of assessment: <emph>MPAQ,</emph> comprehensive questionnaire and/or detailed activity history. It is important to integrate the physical activity assessment into clinical practice.[[<reflink idref="bib121" id="ref161">121</reflink>]] If the application of the questionnaires is not feasible, some important points of consideration while taking activity history in midlife women are presented in [Table 2.3.1].[INLINE:15]</p> <p>Considering the effect of dedicated activity in maintaining cardiometabolic, bone and cognitive health in midlife women, a detailed investigation focusing on the type of exercise (stretching/ strengthening/aerobics/balance), frequency of participation (number of days in a week) and duration of involvement (in minutes) is also recommended (as presented in [Figure 2.3.1]). Experts suggested that the participation of midlife women in household chores might be limited due to the shifting of the household-related responsibilities to younger women. Hence, it is important to assess the daily sitting and screen time as two main indicators of sedentary behaviours in this group of women.[[<reflink idref="bib122" id="ref162">122</reflink>]][INLINE:16]</p> <p>The application of objective methods of physical activity assessment such as wearable activity monitors (WAM) are more commonly used for self-monitoring of daily activity status. A number of technology-driven and consumer-oriented WAMs (e.g. Fitbit) and mobile applications are available for assessment of the number of steps taken per day. However, it is challenging for these methods to assess the intensity of physical activity.[[<reflink idref="bib123" id="ref163">123</reflink>]] The major limitation of this method is that it cannot assess physical activity compliance in accordance with the international activity guidelines of moderate-intensity physical activity.[[<reflink idref="bib121" id="ref164">121</reflink>]]</p> <p>Experts believed that assessment of barriers faced in managing daily physical activity can help practitioners to devise a customised women-centric activity plan. A comprehensive tool for assessment of daily physical activity and barriers associated with maintaining daily activities in Indian midlife women is given in Annexure 4.</p> <p>There is limited literature on comprehensive and practical tools that can be integrated into the clinical workflow with a limited burden on healthcare practitioners and patients. In current literature, the tools only account for the assessment of aerobic activity. As per the international recommendations for advising comprehensive physical activity, muscle strengthening and flexibility should be incorporated twice a week. Clinicians should include questions such as 'How many times in a week do you engage in muscle-strengthening exercises such as bodyweight resistance?' and 'How many times do you participate in flexibility exercises such as stretching and yoga?' in their routine assessment schedule.</p> <p> <emph>2.4: How psychological and behavioural health should be evaluated in midlife women being engaged in the management of overweight and obesity?</emph> </p> <p>Background</p> <p>The question is important as psychological and behavioural health attributes may have an implication as it drives adherence and compliance amongst midlife women engaged in the management of overweight and obesity. The presence of diagnosed psychiatric disorders and clearly discernible psychological attributes may limit the ability of the woman to engage in structured weight-loss interventions. Behaviours such as stress and emotional eating may have an impact on the weight-loss trajectory or an increased probability to regain the initially lost weight. Thus, addressing psychological and behavioural health may be an important consideration in women who undergo weight-loss interventions.</p> <p>The context of psychological and behavioural health holds importance as mental distress in midlife is common, especially depression and anxiety. Personality profile, stress appraisal and stress coping mechanisms may also influence adherence and outcome of weight management efforts. Moreover, eating disorders such as binge eating and food addiction may impair systematic efforts at weight loss by increasing proclivity towards sugar or fat-rich foods, which may lead to weight gain, or may impair weight reduction measures. Considering the role of psychological health in weight management, the assessment of psychological and behavioural health is of importance.</p> <p>Summary of evidence</p> <p>Psychological symptoms such as depression, anxiety, distress, deteriorated sleep and decline in cognitive abilities have been found to be significantly associated with middle-aged women.[[<reflink idref="bib124" id="ref165">124</reflink>]],[[<reflink idref="bib125" id="ref166">125</reflink>]],[[<reflink idref="bib126" id="ref167">126</reflink>]],[[<reflink idref="bib127" id="ref168">127</reflink>]] Literature has also revealed that these symptoms become even worse from the perimenopausal to the post-menopausal transition period.[[<reflink idref="bib128" id="ref169">128</reflink>]] Several psychiatric disorders are also associated with an increase in weight. Common psychiatric disorders such as anxiety and depressive disorders can be associated with obesity. A meta-analysis of cross-sectional studies found anxiety disorders to be associated with 1.4 times the risk of obesity (95% confidence intervals of odds ratio ranging from 1.2 to 1.6).[[<reflink idref="bib129" id="ref170">129</reflink>]] Similarly, another meta-analysis suggested that the presence of depressive disorder was associated with greater odds of developing obesity in later life. Although controlling for baseline BMI and other factors, it was seen that those with depression had 1.18 times the risk of developing obesity.[[<reflink idref="bib130" id="ref171">130</reflink>]] Binge eating disorder is also associated with 3 to 6 times the risk of obesity as compared to those without any eating disorder.[[<reflink idref="bib131" id="ref172">131</reflink>]] Night-eating syndrome is also associated with obesity as per observational studies.[[<reflink idref="bib131" id="ref173">131</reflink>]] It has been seen that the use of psychotropic medications is also associated with obesity and weight gain. Different psychotropic medications have different propensities to cause weight gain. Among the antidepressants, amitriptyline, mirtazapine, and paroxetine are associated with greater weight gain as compared to other medications.[[<reflink idref="bib132" id="ref174">132</reflink>]] Similarly, antipsychotics are associated with weight gain, with clozapine and olanzapine being associated with the highest risk of weight gain.[[<reflink idref="bib133" id="ref175">133</reflink>]]</p> <p>Psychological factors and psychiatric issues can have an impact on weight loss management, affecting the outcome of individuals undergoing weight-loss interventions. It has been seen that baseline mental health correlates with weight change in family physician-led interventions for weight management.[[<reflink idref="bib134" id="ref176">134</reflink>]] Another study found that women with significant weight loss (more than 10%) were more likely to have lower depression at baseline.[[<reflink idref="bib135" id="ref177">135</reflink>]] Similarly, other studies have found psychological issues to be predictors of impaired outcomes of weight-loss interventions.[[<reflink idref="bib136" id="ref178">136</reflink>]],[[<reflink idref="bib137" id="ref179">137</reflink>]] Depression is common among individuals with obesity and RCTs have addressed comorbid depression and obesity (RAINBOW trial and the Be Active Trial).[[<reflink idref="bib138" id="ref180">138</reflink>]],[[<reflink idref="bib139" id="ref181">139</reflink>]] Furthermore, certain weight management interventions have addressed psychological issues as a component of their overall strategy.[[<reflink idref="bib137" id="ref182">137</reflink>]],[[<reflink idref="bib140" id="ref183">140</reflink>]] Thus, psychological issues are a relevant consideration for weight management.</p> <p>The literature search resulted in 22 tools to evaluate psychological and behavioural health in midlife women engaged in managing their weight. Several tools with good psychometric properties are available to assess these psychological and behavioural changes. However, the limitation in using these tools is that they need to be administered by trained psychologists or mental health professionals. Therefore, it is necessary to identify the tools which are validated and can be self -administered. The Menopause-Specific Quality of Life (MENQOL) scale, Menopause Rating Scale (MRS), Women's Health Questionnaire (WHQ), history taking and self-developed validated questionnaire are some of the tools which assess psychological domains including mood disorders, sleep quality, cognitive impairment and somatic symptoms. Two questionnaires specific to female sexual functionality were found to be the Female Sexual Distress Scale-Revised (FSDS-R) and Female Sexual Function Index (FSFI).[[<reflink idref="bib141" id="ref184">141</reflink>]] The Attitudes Toward Menopause Scale (ATMS) can be used to assess the overall perception towards the menopausal symptoms which is directly correlated with the quality of life. Evaluating these domains will help us identify the problematic psychological, social, emotional and behavioural domains and cater to the needs of these women in the management of obesity.</p> <p>Clinical practice recommendations</p> <p>[INLINE:17]</p> <p>Discussion</p> <p>The clinical practice recommendations are based upon the pragmatic assessment of feasibility, along with the clinical relevance of the assessment. We suggest only one aspect of psychological and behavioural health should be routinely asked by anyone/any team providing intervention for weight management: enquiring about the history of psychiatric disorder and the medications being taken for the same. In cases with suspicion, the primary screening tool should be DASS-21 screening depression, anxiety or stress (refer to Annexure 5). The presence of a psychiatric disorder is not a contraindication for weight loss management intervention; however, this information can provide insights into a few issues: whether the disorder is likely to impair efforts at weight loss (depression can be associated with poor energy, lack of interest and altered eating patterns), or whether the psychotropics being used have an impact on the weight (antidepressants such as mirtazapine and antipsychotics such as olanzapine can increase weight).</p> <p>Stress eating presents a unique challenge in weight management intervention and hence should be evaluated by a mental health professional. Such an evaluation can facilitate the implementation of alternate stress management techniques that may help to better deal with stress. Similarly, the presence of significant anxiety or depression may indicate an undiagnosed psychiatric illness, sudden lack of motivation for weight management may indicate adjustment difficulties or the onset of an illness, and persistent/recurrent interpersonal issues may indicate personality problems. All these may be evaluated better by a mental health professional.</p> <p>Good psychological functioning can help midlife women to better engage with the interventions for weight loss management. However, the presence of a psychiatric disorder or significant psychological issues may adversely affect the engagement into intervention, continued efforts at weight management, and overall outcomes of the intervention. Clinicians and experts providing interventions for weight management in midlife women need to be sensitised to the need to consider mental health aspects, which may have an influence on weight gain and may impair the efforts at weight loss. Thus, routinely asking for mental health history can help in appropriate assessment, without significantly increasing the time/depth of assessment. Where major issues are identified as above, a more detailed assessment by a mental health professional can be done to help in ascertaining the mental health problem(s) and for suggesting ameliorative measures. Such assessment is likely to be required in a minority of the cases and may help to improve the outcomes of the midlife women attempting to lose weight.</p> <p> <emph>2.5: What are the important comorbid conditions (cardiometabolic and other medical conditions) that should be evaluated before initiating management of overweight and obesity?</emph> </p> <p>Background</p> <p>Weight gain is an important concern among women in their midlife years. In addition to weight gain, midlife women are predisposed to cardiometabolic comorbidities and obesity-related complications.[[<reflink idref="bib6" id="ref185">6</reflink>]],[[<reflink idref="bib142" id="ref186">142</reflink>]],[[<reflink idref="bib143" id="ref187">143</reflink>]] In the Study of Women's Health Across the Nation (SWAN) study, the chances of cardiometabolic comorbidities including diabetes, hypertension, dyslipidaemia are increased as women undergo menopausal transition.[[<reflink idref="bib144" id="ref188">144</reflink>]] Other obesity-related comorbidities includes non-fatty alcoholic liver (NAFLD), sleep apnoea, polycystic ovary syndrome (PCOS), infertility and osteoarthritis.[[<reflink idref="bib145" id="ref189">145</reflink>]] Studies suggest that midlife-specific factors such as low estrogen deficiency, limited activity, poor dietary habits (low protein and calcium intake) and low vitamin D levels contribute to conditions such as poor bone density, reduced muscle mass and strength, which consequently lead to osteoporosis and sarcopenia.[[<reflink idref="bib146" id="ref190">146</reflink>]],[[<reflink idref="bib147" id="ref191">147</reflink>]] Although there is a need to assess and understand the cumulative role of comorbid conditions in weight management, such a comprehensive approach is rarely used in healthcare settings.[[<reflink idref="bib148" id="ref192">148</reflink>]] It becomes crucial to assess the consequence of comorbid conditions on achieving significant weight loss. The introduction of timely screening, diagnosis and action for prevention and treatment of allied comorbidities will help in improving the overall quality of life in later years.</p> <p>Summary of evidence</p> <p>Across the literature, weight gain has been associated with a number of comorbid conditions ranging from metabolic, mental, musculoskeletal and other obesity-related disorders. Out of 23 studies, nine studies reported a positive correlation of clustering of one or more components of metabolic syndrome (elevated lipid profile, insulin resistance and high blood pressure, and elevated inflammatory markers) with weight gain, total body fat and central adiposity.[[<reflink idref="bib142" id="ref193">142</reflink>]],[[<reflink idref="bib149" id="ref194">149</reflink>]],[[<reflink idref="bib150" id="ref195">150</reflink>]],[[<reflink idref="bib151" id="ref196">151</reflink>]] A higher incidence of cardiovascular events was observed in six studies among obese menopausal women.[[<reflink idref="bib152" id="ref197">152</reflink>]],[[<reflink idref="bib153" id="ref198">153</reflink>]],[[<reflink idref="bib154" id="ref199">154</reflink>]]</p> <p>Besides weight gain and fat accumulation, women in midlife are also subjected to declining lean mass, bone health and muscle strength leading to musculoskeletal diseases such as sarcopenia and osteoporosis. In addition, factors such as chronological ageing, post-menopausal status, perceived barriers for exercise and limited consumption of calcium-rich foods were also positively associated with osteoporosis.[[<reflink idref="bib155" id="ref200">155</reflink>]],[[<reflink idref="bib156" id="ref201">156</reflink>]] Studies report a positive correlation between central obesity and increased risk of fractures especially hip fracture among menopausal women.[[<reflink idref="bib157" id="ref202">157</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:18]</p> <p>Discussion</p> <p>Weight gain during menopausal transition is associated with a range of non-communicable chronic conditions.[[<reflink idref="bib2" id="ref203">2</reflink>]] We identified some important comorbid conditions that are generally associated with obesity in midlife women: metabolic syndrome, diabetes, cardiovascular diseases such as heart attack and stroke, osteoporosis, osteoarthritis and sarcopenia.[[<reflink idref="bib158" id="ref204">158</reflink>]],[[<reflink idref="bib159" id="ref205">159</reflink>]] It can be noted that multifactorial risk factors specific to midlife such as hormonal and physiological changes coupled with unhealthy lifestyle habits make these women prone to weight gain and consequently to increased cardiometabolic risk as compared to other reproductive phases.[[<reflink idref="bib160" id="ref206">160</reflink>]] The guidelines for screening of cardiovascular risk factors in adults can be referred from the American Heart Association Task Force on Clinical Practice Guidelines available from https://www.ahajournals.org/doi/10.1161/CIR.0000000000000678.[[<reflink idref="bib161" id="ref207">161</reflink>]]</p> <p>Apart from cardiovascular diseases, women suffer from sarcopenic obesity marked by a reduction in muscle mass coupled with an increase in fat mass leading to reduced physical performance.[[<reflink idref="bib162" id="ref208">162</reflink>]] Poor bone mass and decreased bone mineral density also contribute to compromised mobility and physical functionality interfering with daily life activities.[[<reflink idref="bib147" id="ref209">147</reflink>]] Factors such as consumption of a diet low in protein and calcium, long-term physical inactivity and low exposure to sunlight are some factors related to musculoskeletal conditions.[[<reflink idref="bib163" id="ref210">163</reflink>]],[[<reflink idref="bib164" id="ref211">164</reflink>]] According to the Asian Working Group for Sarcopenia (AWGS) Criteria, if feasible, bioelectric impedance can be used for assessing muscle strength and muscle mass. In addition, a detailed history of fractures, dietary habits, physical activity level, and alcohol consumption should also be taken. The consensus on diagnosis and management of sarcopenia in adults as per the AWGS working group is available at https://pubmed.ncbi.nlm.nih.gov/32033882/.[[<reflink idref="bib163" id="ref212">163</reflink>]]</p> <p>In a resource-rich setting, bone health can be assessed using a Dual-energy X-ray machine (DXA) or vertebral imaging.[[<reflink idref="bib105" id="ref213">105</reflink>]] Furthermore, the clinical practice guidelines on screening and management of osteoporosis in midlife women are available at https://pubmed.ncbi.nlm.nih.gov/33281419/.[[<reflink idref="bib164" id="ref214">164</reflink>]]</p> <p> <emph>2.6: How should menopause-related symptoms be evaluated in midlife women being engaged in the management of overweight and obesity?</emph> </p> <p>Background</p> <p>Menopause is a transition from a reproductive to a non-reproductive phase marked by the emergence of specific symptoms. The changes in menstrual cyclicity as a symptom is a clinical marker of the onset of the menopause transition at the later stages of the reproductive cycle.[[<reflink idref="bib165" id="ref215">165</reflink>]] The menopausal symptoms can be categorised as physical, psychological, vasomotor, genitourinary, and sexual symptoms. There can be variation in the type, frequency, and severity of menopausal symptoms experienced by midlife women. Vasomotor symptoms are considered as primary symptoms of menopause causing hot and cold sweats, especially in the upper body.[[<reflink idref="bib164" id="ref216">164</reflink>]] Somatic symptoms include musculoskeletal pains, which are associated with the menopausal transition status. Often, musculoskeletal pain is associated with BMI, fatigue, sleep disturbance, mood disorder, anxiety and stress.[[<reflink idref="bib166" id="ref217">166</reflink>]] Further, the biological decline in ovarian function is also associated with psychological distress leading to episodes of mood disturbances, irritability, anxiety, depression and poor sleep, especially during the menopausal transition.[[<reflink idref="bib165" id="ref218">165</reflink>]],[[<reflink idref="bib167" id="ref219">167</reflink>]] Both vasomotor symptoms and psychological distress lead to poor sleep quality in menopausal women.[[<reflink idref="bib168" id="ref220">168</reflink>]]</p> <p>Across the literature, menopausal symptoms have been associated with lifestyle-related practices in a way that can promote overweight and obesity in midlife women. Women with higher total menopausal symptom severity scores are known to have a higher caloric intake, especially from HFSS foods. It has been observed that midlife women having joint issues have limited participation in physical activity leading to weight gain over time.[[<reflink idref="bib169" id="ref221">169</reflink>]] Similarly, women reporting higher vasomotor symptom severity often report greater sleep disturbances and emotional volatility.[[<reflink idref="bib170" id="ref222">170</reflink>]] Considering the association between menopausal symptom severity with the key lifestyle practices associated with weight gain in menopausal women, an assessment of menopausal symptom severity should be undertaken by clinicians, especially in symptomatic women. The assessment should be done objectively to classify menopausal women into mild, moderate and severe categories.[[<reflink idref="bib171" id="ref223">171</reflink>]]</p> <p>Summary of evidence</p> <p>Across the literature, a total of seven questionnaires assessing the menopausal-related symptoms in middle-aged women were identified. The identified questionnaires are condition-specific questionnaires that assess symptoms experienced by middle-aged women undergoing menopausal transition. All the questionnaires can be self-administered to examine menopausal symptoms. Five questionnaires measured menopause-specific symptoms including vasomotor, physical, psychological, urogenital, and sexual symptoms. Other symptoms such as cognitive impairment, body image issues, sleep disorder, perceived loss of control, and numbness were assessed in three questionnaires: Women's Health Questionnaire (<emph>36-items</emph>), Menopause Symptoms Severity Inventory (<emph>38-items</emph>), and Self-developed validated questionnaire (<emph>41-items</emph>).[[<reflink idref="bib35" id="ref224">35</reflink>]],[[<reflink idref="bib172" id="ref225">172</reflink>]],[[<reflink idref="bib173" id="ref226">173</reflink>]] On the basis of severity, the symptoms were rated on a Likert-scale response scale ranging from not severe (lowest score) to maximum severity (highest scores). Questionnaires such as <emph>Menopause Specific Quality of Life</emph> calculated domain-wise scores, whereas <emph>Menopause Rating Scale, Greene Climacteric scale</emph> and <emph>Kupperman's index</emph> calculated total scores for all the menopausal symptoms.[[<reflink idref="bib174" id="ref227">174</reflink>]],[[<reflink idref="bib175" id="ref228">175</reflink>]],[[<reflink idref="bib176" id="ref229">176</reflink>]],[[<reflink idref="bib177" id="ref230">177</reflink>]] The higher scores indicate severe menopausal symptoms and lower scores indicate mild menopausal symptoms.</p> <p>These questionnaires are concise, valid and reliable measures for assessment of menopause symptoms severity in women. There is a lack of menopause symptom assessment scales specific to middle-aged Indian women. There is a need for the development and validation of simple, practical, and feasible tools to assess menopausal symptom severity in Indian women.</p> <p>Clinical practice recommendations</p> <p>[INLINE:19]</p> <p>Discussion</p> <p>Menopause is retrospectively diagnosed considering menstrual irregularities. The assessment of menopause using biochemical parameter follicle-stimulating hormone (FSH) is initiated in special cases or during infertility.[[<reflink idref="bib165" id="ref231">165</reflink>]] Further, the severity of menopausal symptoms can be assessed using a number of developed and validated questionnaires. Often, these scales assess menopause symptom severity in relation to the overall life quality in midlife women. The commonly used scales includes Menopause Rating Scale (MRS), Greene's Climacteric Scale, and Menopause Specific Quality of Life (MENQOL).[[<reflink idref="bib172" id="ref232">172</reflink>]],[[<reflink idref="bib174" id="ref233">174</reflink>]],[[<reflink idref="bib175" id="ref234">175</reflink>]] According to the Practice Guideline on Menopause, MRS is the recommended self-administered tool for screening of the severity of the menopausal symptoms in midlife Indian women (refer to Annexure 6).[[<reflink idref="bib11" id="ref235">11</reflink>]] The MRS is also translated and validated in Hindi language for easier administration in Indian women.[[<reflink idref="bib178" id="ref236">178</reflink>]] However, the integration of MRS in clinical practice for the management of weight in midlife women is still lacking. An adapted version of MRS in Indian women is also given as a part of a comprehensive assessment tool for an overall assessment of menopausal symptoms and lifestyle-related factors for appropriate weight management in Indian women (shown in Annexure 4). According to the WHO, the categorization of the menopause symptom severity in midlife women is decided on the percentage of menopausal symptoms and can range from no problem (0-4%) to complete problem (95–100%).</p> <p>Section III: Management of overweight and obesity</p> <p> <emph>3.1: How stepwise weight loss goals should be set for midlife women being engaged in the management of overweight and obesity?</emph> </p> <p>Background</p> <p>Goal setting is a common behaviour change strategy that is considered a fundamental component of successful weight loss intervention.[[<reflink idref="bib179" id="ref237">179</reflink>]] Weight loss goals should be patient-centric, realistic, practical and mutually set with the help of a healthcare provider. Generally, a weight loss goal is set in terms of absolute or percentage reduction from baseline weight at the end of the intervention.[[<reflink idref="bib78" id="ref238">78</reflink>]] In addition to weight loss, incorporation of corrective lifestyle habits and improvement in cardiometabolic, menopausal and overall health should also be considered while setting weight loss goals in midlife women. The S.T.A.R.T criteria (Specificity, Timing, Acquisition, Rewards and feedback, and Tools) is considered useful for promoting health behaviour change to set goals that are specific, timely, self-determined, and supported by self-monitoring tools, feedback and rewards.[[<reflink idref="bib179" id="ref239">179</reflink>]] This can help in directing the midlife woman's attention and efforts in defining relevant strategies for accomplishing her future weight and health goals.[[<reflink idref="bib180" id="ref240">180</reflink>]] However, the nature of weight loss goals for initiating lifestyle modification intervention and its association with achieving therapeutic weight loss has not been systematically explored. Hence, we undertook this question of clinical relevance to understand the type of weight loss and health goals that should be set for midlife women and their association with achieving weight loss success.</p> <p>Summary of evidence</p> <p>Across trials, weight loss goals were defined in terms of lost weight, improvement in cardiometabolic risk factors and menopausal symptom severity. The American Heart Association (AHA) guidelines suggested that a modest weight loss goal of 5–10% should be initially targeted for individuals seeking weight loss treatment. A modest weight loss of 5–10% was related to improvements in cardiometabolic risk factors and other obesity-related disorders. Most RCTs also aimed at reducing 5–10% in a duration of 6–12 months.[[<reflink idref="bib53" id="ref241">53</reflink>]],[[<reflink idref="bib76" id="ref242">76</reflink>]],[[<reflink idref="bib90" id="ref243">90</reflink>]] Similar consistent findings were reported in four systematic reviews where the achievement of 5–10% weight loss was associated with improvement in hypertension, hyperlipidaemia, and blood glucose fasting.[[<reflink idref="bib181" id="ref244">181</reflink>]],[[<reflink idref="bib182" id="ref245">182</reflink>]],[[<reflink idref="bib183" id="ref246">183</reflink>]] Any further improvement in weight correlated with graded improvement in obesity-related diseases such as non-fatty liver disease, and sleep apnoea. Weight loss was also associated with improvement in polycystic ovary disease, regularity of menstrual cycle and fertility in women.[[<reflink idref="bib182" id="ref247">182</reflink>]] A limited number of experimental studies reported that a weight loss of 10% can be associated with a reduction in menopause-related hot flushes.[[<reflink idref="bib46" id="ref248">46</reflink>]],[[<reflink idref="bib184" id="ref249">184</reflink>]] The improvement in other comorbidities such as depression, mobility, sexual dysfunction, and urinary stress incontinence and overall quality of life was also associated with a reduction of 5–10% body weight. The further reduction of body weight correlates with a graded improvement in cardiometabolic and obesity-related disease status.</p> <p>In addition to quantitative weight loss goals, attention should be given to setting realistic and patient-centric goals.[[<reflink idref="bib78" id="ref250">78</reflink>]],[[<reflink idref="bib182" id="ref251">182</reflink>]] The weight loss goals should also be discussed with the woman in the context of any competing priorities in the woman's everyday life that might hinder the achievement of the set goal. The woman's readiness to achieve the weight and health goal can also be ascertained before initiating a comprehensive lifestyle management program.[[<reflink idref="bib78" id="ref252">78</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:20]</p> <p>Discussion</p> <p>The recommended weight loss goals for midlife women seeking lifestyle modification treatment for weight loss are similar to previous recommendations for the adult population.[[<reflink idref="bib78" id="ref253">78</reflink>]],[[<reflink idref="bib86" id="ref254">86</reflink>]] Initially, the readiness to change existing lifestyle-related behaviours, especially dietary and physical activity behaviours to lose weight should be assessed in midlife women. The transtheoretical model (TTM) of health behaviour change defines the 'readiness of change' across five stages: pre-contemplation, contemplation, preparation, action, and maintenance (as shown in [Figure 3.1.1]). Generally, the proportion of population at-risk is 40% in pre-contemplation, 40% in contemplation and 20% in the action stage.[[<reflink idref="bib185" id="ref255">185</reflink>]] An early understanding of the readiness and motivation to change can help clinicians and healthcare professionals in devising customised weight loss and health goals. For example: at the precontemplation stage, providing education on the consequences of weight gain in later life can be an optimum goal. At the contemplation stage, setting personal weight and health goals can be set in detailed discussion with the healthcare provider. Across the literature, a modest and realistic weight loss goal of 5-10% reduction from baseline body weight in 6 months is recommended as it has significant clinical benefits. For setting sustainable goals, healthcare providers should educate women that a target of 0.5-1 kg weight loss per week should be undertaken.[[<reflink idref="bib186" id="ref256">186</reflink>]] Ideally, the weight management efforts should be continued till the midlife woman has achieved the ideal weight status. Furthermore, healthcare providers should discuss lifelong weight management efforts for the sustenance of appropriate weight in the long term.[[<reflink idref="bib86" id="ref257">86</reflink>]] It should be noted that goal setting is an important component of the behavioural strategy for weight management. Currently, there is a lack of well-designed interventions assessing goal pursuits (goal setting and goal striving) amongst adults participating in weight loss programs.[[<reflink idref="bib187" id="ref258">187</reflink>]] Furthermore, across weight loss literature, goal setting is considered as an initial step rather than an ongoing process. Goal setting as a process includes finalizing weight loss goals, and reflecting on and receiving feedback from healthcare providers to successfully achieve the initially set goals during the lifestyle modification intervention. In addition, customization of weight loss plans to manage the barriers faced by the participant during the intervention should be incorporated as a part of goal striving.[[<reflink idref="bib179" id="ref259">179</reflink>]],[[<reflink idref="bib188" id="ref260">188</reflink>]] The incorporation of goal pursuit can help to achieve and sustain therapeutic weight loss.[INLINE:21]</p> <p> <emph>3.2: What type of dietary recommendations should be advised for improving weight loss, anthropometric and metabolic health outcomes?</emph> </p> <p>Background</p> <p>Dietary modification is the cornerstone of weight management. Dietary modification aims at reducing the caloric intake for creating a negative calorie balance to produce weight loss.[[<reflink idref="bib189" id="ref261">189</reflink>]] Other dietary recommendations include having a balanced diet, adequate protein intake, consumption of fruits and vegetables and limiting consumption of calorie-dense foods with a high proportion of fat, salt, and sugar to improve the quality of the meals.[[<reflink idref="bib190" id="ref262">190</reflink>]] Further, improvements in the meal pattern in terms of number, type, frequency and portions size of meals is also recommended.[[<reflink idref="bib191" id="ref263">191</reflink>]] Across the literature, different dietary modification techniques have been recommended for achieving weight loss, improving the cardiometabolic profile and menopausal health in midlife women. The understanding of a comprehensive dietary intervention that can prove effective in managing weight, metabolic and menopausal health in midlife women is still lacking. Moreover, the dietary interventions recommended across weight-loss trials can be mostly prescribed by trained healthcare professionals such as registered dietitians and nutritionists. The availability of trained professionals across healthcare settings in developing countries such as India might be difficult. There is a need for simple, practical and technically feasible recommendations that can be prescribed by healthcare professionals during patient encounters across healthcare settings. Hence, this clinical question was undertaken to identify effective dietary strategies for weight management in midlife Indian women.</p> <p>Summary of evidence</p> <p>Dietary interventions for managing overweight and obesity in midlife women were prescribed for an average duration of 6 months; ranging from 21 days to 48 months across trials.[[<reflink idref="bib94" id="ref264">94</reflink>]],[[<reflink idref="bib192" id="ref265">192</reflink>]] The dietary interventions aims to achieve weight loss by creating a negative calorie balance. In all the dietary interventions, calorie restriction (500 kcal per day) from the baseline intake was prescribed after the estimation of an individual's energy requirement.[[<reflink idref="bib114" id="ref266">114</reflink>]] Studies also specified the daily energy intake ranging from 1000–2000 kcal.[[<reflink idref="bib76" id="ref267">76</reflink>]],[[<reflink idref="bib192" id="ref268">192</reflink>]] The ad libitum approaches of energy restriction were not prescribed, but lower caloric intake was prescribed by manipulation of macronutrient composition. A number of dietary approaches including macronutrient manipulation with caloric restriction were recommended: AHA style diet (fat <30% of total calories, <10% from saturated fat), Very Low-Calorie Diet, Low Carbohydrate, Glycemic-Load and Fat Diet, Mediterranean Diet and High Protein Diet.[[<reflink idref="bib78" id="ref269">78</reflink>]] The most common dietary interventions were based on a calorie-restricted diet with the following macronutrient composition: carbohydrate 50%-60%, fats 30%, and protein 10%-20%. In a low carbohydrate diet, carbohydrate intake ranged from 5-15% of the total calories.[[<reflink idref="bib66" id="ref270">66</reflink>]],[[<reflink idref="bib83" id="ref271">83</reflink>]] The prescription on the incorporation of high dietary fibre (soluble and insoluble) foods was incorporated in four RCTs and one experimental study. A dietary fibre intake of 20 to 30 grams per day was prescribed from whole grains, nuts, oilseeds, fruits and vegetables. The average protein intake of 10-20% was prescribed in most diets with the focus on the consumption of at least one serving of lean meat sources in non-vegetarian diets.[[<reflink idref="bib193" id="ref272">193</reflink>]] Low Calorie, High Protein diet (25-30% of energy) was prescribed in three studies with the focus on the consumption of lean meats, non-fat dairy, nuts and pulses.[[<reflink idref="bib83" id="ref273">83</reflink>]],[[<reflink idref="bib192" id="ref274">192</reflink>]],[[<reflink idref="bib194" id="ref275">194</reflink>]] Low-fat diets are defined as diets with less than 30% of total energy intake from fats were prescribed in six trials. In addition, two studies reported Mediterranean style diet prescribing daily consumption limit of different fatty acids based on the proportion of total fat intake: saturated fats (<7%), polyunsaturated fatty acids (PUFA) (9%), monounsaturated fatty acids (MUFA) (20%), and cholesterol intake < 1% per day.[[<reflink idref="bib77" id="ref276">77</reflink>]],[[<reflink idref="bib80" id="ref277">80</reflink>]] Other dietary prescriptions were based on recommended country-specific healthy dietary patterns (Dietary Recommendations for Americans) and landmark weight loss trials (Diabetes Prevention Program and Look AHEAD) focusing on improving the overall dietary quality.[[<reflink idref="bib50" id="ref278">50</reflink>]],[[<reflink idref="bib195" id="ref279">195</reflink>]] These prescriptions were limited to healthy eating practices such as consumption of lean protein, limited fat, salt and sugar (≤10 g) intake and consumption of fruits and vegetables. Two trials assessed ways of calorie restriction via intermittent fasting with continuous calorie restriction as an approach for the management of weight and other biochemical parameters.[[<reflink idref="bib45" id="ref280">45</reflink>]],[[<reflink idref="bib196" id="ref281">196</reflink>]] Only two studies focused on providing education on healthy dietary practices such as meal pattern, portion size, Eatwell plate, emotional eating, reading food labels as strategies for management of weight in midlife women.[[<reflink idref="bib49" id="ref282">49</reflink>]],[[<reflink idref="bib110" id="ref283">110</reflink>]] In midlife women, dietary management included supplementation of phytoestrogen from soy-based products, omega-3 for essential fatty acid, and calcium and vitamin D for weight management.[[<reflink idref="bib75" id="ref284">75</reflink>]],[[<reflink idref="bib83" id="ref285">83</reflink>]],[[<reflink idref="bib113" id="ref286">113</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:22]</p> <p>Discussion</p> <p>The dietary recommendations in midlife women are based on the principles of caloric restriction, balanced diet and healthy eating practices. The caloric restrictions should be individualised by accounting for the current dietary and activity habits, comorbidities and previous dieting attempts. A daily caloric restriction of 500–750 kcal is optimum for losing 0.5-1 kg weight per week.[[<reflink idref="bib197" id="ref287">197</reflink>]] Generally, in clinical practice, a hypocaloric balanced diet of around 1000-1200 kcal is prescribed in adult women.[[<reflink idref="bib2" id="ref288">2</reflink>]],[[<reflink idref="bib194" id="ref289">194</reflink>]] A total of 15-30% caloric restriction with respect to habitual caloric intake is optimum for weight loss. However, clinicians should note that patients often underreport caloric intake and overestimate caloric expenditure.</p> <p>The caloric restriction should be translated into optimum macronutrient manipulation. In the current literature, different diets based on acceptable macronutrient distribution range are low carbohydrate (45–55%), high protein (10–35%), low fat (20–30%) and low glycaemic index diet.[[<reflink idref="bib66" id="ref290">66</reflink>]],[[<reflink idref="bib83" id="ref291">83</reflink>]],[[<reflink idref="bib192" id="ref292">192</reflink>]] There is inconsistent evidence that these diets are beneficial over the hypocaloric balanced diet. However, these diets have been shown to improve the cardiometabolic risk factors such as dyslipidaemia, type 2 diabetes and blood pressure. In some cases, the total carbohydrates should be restricted (<26% per 2000 kcal caloric intake) and complex carbohydrates with a low glycaemic index should be incorporated.[[<reflink idref="bib198" id="ref293">198</reflink>]] The targeted daily fibre intake should be around 30 grams from fruits and vegetables (4-5 servings per day), legumes (1-2 servings), nuts and oilseeds (1–2 servings) and whole-grain flour. Special attention should be given to adequate protein intake as per the estimated average requirement for maintaining optimum muscle and bone health in midlife women.[[<reflink idref="bib199" id="ref294">199</reflink>]] A very low-calorie diet (500–800 kcal) might lead to micronutrient deficiency in the long term. These diets should preferably be recommended by trained healthcare professionals such as nutritionists and dietitians.</p> <p>Healthcare providers should consider personal and cultural food habits while prescribing any dietary modification. Fixing the meal pattern can also be helpful in avoiding fasting and feeding cycles throughout the day. For the main meals, these women should be encouraged to adjust the servings of the foods according to the 'EatWell' plate.[[<reflink idref="bib200" id="ref295">200</reflink>]] The caloric manipulation should be supplemented with generic advice on healthy eating behaviours. Some generic advice can be: limit the consumption of HFSS, avoid skipping meals, adequate intake of water, decrease the portion size, avoid eating out, and manage episodes of emotional eating.[[<reflink idref="bib189" id="ref296">189</reflink>]]</p> <p>In addition, the consumption of micronutrients should be recommended in accordance with the estimated average requirement (EAR). The daily intake of iron (29 mg), calcium (1000 mg) and other B-complex vitamins should be planned from dietary sources available in Indian diets (refer to Annexure 7).[[<reflink idref="bib199" id="ref297">199</reflink>]] The dietary sources of iron, calcium and phytoestrogen are presented in Annexure 8. If women are found deficient, supplementations can be recommended as per clinical indications. The detailed clinical practice guideline for iron deficiency anaemia in women (age > 15 years) can be accessed from:https://www.nhm.gov.in/images/pdf/programmes/child-health/guidelines/Control-of-Iron-Deficiency-Anaemia.pdf.[[<reflink idref="bib201" id="ref298">201</reflink>]] Considering the practical limitations for the consumption of Vitamin D from natural dietary sources, Vitamin D supplementations can be recommended in cases of deficiency as per clinical recommendations under the guidance of a clinician. The detailed clinical practice recommendations on the management of micronutrient deficiency (calcium and vitamin D) in midlife women are available from https://pubmed.ncbi.nlm.nih.gov/33281419/.[[<reflink idref="bib164" id="ref299">164</reflink>]] Women suffering from severe menopausal symptoms can also be prescribed supplementations of phytoestrogen from natural sources, especially soy-based products.[[<reflink idref="bib202" id="ref300">202</reflink>]] The reinforcement of healthy eating habits during intervention is important for the long-term sustenance of weight loss.</p> <p> <emph>3.3: What type of physical activity recommendations should be advised for improving weight loss, anthropometric and metabolic health outcomes?</emph> </p> <p>Background</p> <p>Physical activity is defined as all movements that can lead to caloric expenditure.[[<reflink idref="bib203" id="ref301">203</reflink>]] The caloric expenditure is important for creating an energy deficit required to produce a reduction in weight. Generally, women with overweight and obesity are recommended to incorporate exercise in their daily regime to increase the caloric deficit. Exercise is structured and planned physical activity.[[<reflink idref="bib204" id="ref302">204</reflink>]] The midlife women can be suggested different types of exercises including aerobic exercise for maintaining cardiometabolic health, strength training for increasing bone and muscle mass and balance exercises for maintaining posture and flexibility.[[<reflink idref="bib205" id="ref303">205</reflink>]],[[<reflink idref="bib206" id="ref304">206</reflink>]],[[<reflink idref="bib207" id="ref305">207</reflink>]] Healthcare providers should recommend the type, intensity, duration and frequency of exercise in a patient-centric, simple and feasible manner.[[<reflink idref="bib208" id="ref306">208</reflink>]] Further, the activity recommendations should be menopause friendly, i.e. it should not aggravate any menopausal symptoms such as vasomotor symptoms or joint pains. It is important to understand the effective combination of exercises that can help in producing significant weight loss. In current literature, the effectiveness of independent exercise and/or a combination of exercise regimes in producing significant weight loss in midlife women is lacking. Hence, this clinical question was undertaken to identify the type and nature of exercises that can help in improving weight loss and overall health-related outcomes in midlife women.</p> <p>Summary of evidence</p> <p>Physical activity prescriptions for midlife women to manage overweight and obesity were based on pre-existing recommendations from the American College of Sports Medicine and National Strength and Conditioning Guidelines.[[<reflink idref="bib79" id="ref307">79</reflink>]],[[<reflink idref="bib205" id="ref308">205</reflink>]] Most studies recommend different types of physical activity in collaboration with caloric restrictions for managing weight in midlife women. The total duration of interventions ranged from 10 weeks to 18 months.[[<reflink idref="bib209" id="ref309">209</reflink>]],[[<reflink idref="bib210" id="ref310">210</reflink>]] During the intervention, an average of three exercise sessions were planned in a week. Only one study planned a stepwise increase in the number of sessions ranging from three sessions per week to five sessions per week.[[<reflink idref="bib51" id="ref311">51</reflink>]] Exercise sessions were planned in a phasic manner starting with a warm-up, exercise and cool down.[[<reflink idref="bib207" id="ref312">207</reflink>]] The duration of the exercise sessions varied from 50 to 65 min, except for one study which reported 90-minute walking sessions.[[<reflink idref="bib53" id="ref313">53</reflink>]] Studies have recommended different activities including aerobics, resistance training and endurance, stretching, and combined exercise circuits. Six trials recommended moderate (60-70% Heart Rate Maximum (HRmax) to vigorous (70-80% HRmax) intensity aerobic exercises including walking, nordic walking, jogging, swimming, bicycling, ergo cycling, treadmill and video-based aerobic exercise only one trial focused on moderate (HRmax 50-75%) intensity endurance exercises including upper limb, spine-stabilizing, deep muscle-forming, lower limb and balance-adjusting exercises.[[<reflink idref="bib79" id="ref314">79</reflink>]] Three studies focused on the role of resistance training of all major muscle groups and core exercises. The resistance training included different types of exercises such as leg press, leg extensions, calf raises, chest press, lateral pull-downs, shoulder press and triceps extension.[[<reflink idref="bib194" id="ref315">194</reflink>]],[[<reflink idref="bib205" id="ref316">205</reflink>]],[[<reflink idref="bib211" id="ref317">211</reflink>]] Five trials customised exercise circuits for management of weight in midlife women. The following exercise circuits were recommended: aerobics and resistance exercises, high-intensity interval training (HIIT) and resistance exercises, walking and weight-bearing exercises.[[<reflink idref="bib51" id="ref318">51</reflink>]],[[<reflink idref="bib79" id="ref319">79</reflink>]],[[<reflink idref="bib207" id="ref320">207</reflink>]] The aim of these circuits was to reduce the total body fat and visceral fat (especially HIIT), improve lean muscle mass, bone mineral density, physical capacity and maximum range of oxygen (VO<subs>2</subs> max). Only one trial reported the importance of aerobic exercises in managing distress, hot flushes as climacteric symptoms and health-related overall quality of life (HRQoL).[[<reflink idref="bib212" id="ref321">212</reflink>]] An experimental study reported that involvement in 60 min of daily physical activity helps in improving climacteric symptoms and psychological distress.[[<reflink idref="bib213" id="ref322">213</reflink>]] Social support from coaches in maintaining regular engagement in physical activity did not contribute to an increased frequency of engagement in physical activity.[[<reflink idref="bib214" id="ref323">214</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:23]</p> <p>Discussion</p> <p>A personalised, progressive and stepwise exercise regime should be planned by the healthcare provider. According to the Australian pre-exercise screening guide, factors such as cardio-respiratory health, musculoskeletal strength, and pre-existing clinical conditions should be assessed before recommending an exercise regime.[[<reflink idref="bib215" id="ref324">215</reflink>]] The recommendations are derived from RCTs that incorporate both dietary restrictions and physical activity for weight regulation. Most studies comparing exercise alone vs exercise and diet as components of weight loss intervention report that exercise alone results in minimal weight loss. According to the position statement from the American College of Sports Medicine and American Diabetes Association, "up to 60 min/day physical activity alone is required to produce weight loss".[[<reflink idref="bib216" id="ref325">216</reflink>]] Similarly, clinical recommendations from the American Academy of Clinical Endocrinologists (AACE) and the American College of Endocrinology also state that 150 minutes of moderate-intensity aerobic exercise improves weight loss outcomes and improvement in intensity and duration can lead to improved weight and fat loss.[[<reflink idref="bib217" id="ref326">217</reflink>]] The intensity of aerobic exercises can be assessed using the talk test: comfortable speech denotes light intensity, speech with some difficulty denotes moderate intensity and speech limited to phrases denotes vigorous intensity.[[<reflink idref="bib218" id="ref327">218</reflink>]] Besides, resistance and weight-bearing exercises are recommended twice a week for enhancing muscle and bone mass. It should be noted that exercise should be done for all major muscle groups, preferably with the help of a trainer.[[<reflink idref="bib219" id="ref328">219</reflink>]] The overall muscle functioning can also be improved with the help of stretching and flexibility exercises. Regular practice of yogic postures (asanas) can also help in improving flexibility. Midlife women can undertake yoga consisting of postures (<emph>asanas</emph>), controlled breathing (<emph>pranayama</emph>) and meditation (<emph>dhyana</emph>) for maintaining physical, mental and emotional well-being.[[<reflink idref="bib220" id="ref329">220</reflink>]]</p> <p>A comprehensive exercise regime including moderate-intensity aerobic, resistance and flexibility exercises should be planned for overall weight loss and health benefits. For example: initiating warm-up (5–10 min) with stretching to ensure flexibility, engaging in moderate-intensity aerobic exercises (30–45 min) for increasing heart rate and improving cardiometabolic health, followed by resistance exercises (15–20 min) for muscle and bone strength and cool down (5–10 min) to relax the muscles.[[<reflink idref="bib219" id="ref330">219</reflink>]] Different activities that can be planned in each exercise category are presented in [Table 3.3.1].[INLINE:24]</p> <p>The management of exercise should also include mitigating barriers faced by midlife women to ensure optimum engagement in physical activity. Healthcare providers should ensure regular follow-up to understand women-centric barriers in managing physical activity.</p> <p>In current literature, the effect of 'exercise alone' interventions on achieving significant weight loss and cardiometabolic outcomes is still lacking. Furthermore, the effect of exercise intensity, frequency and duration on weight loss outcomes can be explored for devising better exercise regimes for weight loss in midlife women.</p> <p> <emph>3.4: What are the behaviour modification techniques that should be incorporated in weight-management advice?</emph> </p> <p>Background</p> <p>Lifestyle modification for weight management focuses on changes in dietary habits, physical activity patterns and behavioural counselling. While incorporating dietary and activity-related modifications, women face a range of barriers associated with adoption and long-term compliance consequently leading to unsuccessful outcomes.[[<reflink idref="bib221" id="ref331">221</reflink>]] It is important to empower patients with behavioural modification skills which may help them to overcome their challenges in adopting healthy lifestyle modifications.[[<reflink idref="bib222" id="ref332">222</reflink>]] Behavioural modification techniques can play a pivotal role in restructuring an individuals' lifestyle habits.[[<reflink idref="bib223" id="ref333">223</reflink>]] These behavioural modification strategies can be inculcated with the help of a behavioural specialist and/or psychologist in collaboration with a multidisciplinary team of doctors, nutritionists and exercise specialists.[[<reflink idref="bib224" id="ref334">224</reflink>]] Some of the effective strategies suggested in the literature include goal-setting, self-monitoring, coping strategies, stimulus control, cognitive restructuring, and relapse prevention.[[<reflink idref="bib54" id="ref335">54</reflink>]],[[<reflink idref="bib115" id="ref336">115</reflink>]],[[<reflink idref="bib225" id="ref337">225</reflink>]],[[<reflink idref="bib226" id="ref338">226</reflink>]] Midlife women should be educated to apply these behavioural strategies to mitigate the challenges they face while trying to incorporate healthy lifestyle practices. However, there is a lack of comprehensive list of behavioural strategies established particularly for addressing issues faced by midlife women. Hence, effective behavioural strategies should be identified to counsel women in midlife during the weight management process.</p> <p>Summary of evidence</p> <p>Comprehensive weight management in midlife women was based on three components: diet, physical activity and behavioural modification recommendations. The behavioural intervention can be delivered via web-based, group-based and individualised sessions for a duration ranging from 3 months to 60 months.[[<reflink idref="bib54" id="ref339">54</reflink>]],[[<reflink idref="bib225" id="ref340">225</reflink>]],[[<reflink idref="bib227" id="ref341">227</reflink>]] These sessions were delivered by nutritionists, doctors and behavioural therapists. Only one study had a multidisciplinary team for behavioural weight loss counselling.[[<reflink idref="bib228" id="ref342">228</reflink>]] A number of behavioural strategies were recommended to enhance compliance to dietary and activity advice in the long term: goal setting, motivational interviewing, self-monitoring, positive reinforcement, thought process, coping skills, problem-solving, and social support. During the initiation of weight management, goal setting was used as a behavioural strategy to set realistic and practical weight reduction goals.[[<reflink idref="bib54" id="ref343">54</reflink>]],[[<reflink idref="bib55" id="ref344">55</reflink>]],[[<reflink idref="bib229" id="ref345">229</reflink>]] During the intervention, motivational interviewing as a technique was used to advise healthy eating behaviours including fibre consumption and activity habits including completing 10,000 steps.[[<reflink idref="bib48" id="ref346">48</reflink>]],[[<reflink idref="bib115" id="ref347">115</reflink>]] Dietitian-led counselling sessions or seminars were planned for improvement in eating behaviours such as reading labels, eating out, coping skills for emotional eating, recipe substitution, and selection of foods.[[<reflink idref="bib226" id="ref348">226</reflink>]],[[<reflink idref="bib227" id="ref349">227</reflink>]],[[<reflink idref="bib230" id="ref350">230</reflink>]] At follow-up, self-monitoring of diet, activity and weight was the most common behavioural strategy that was adopted for managing corrective eating and activity.[[<reflink idref="bib54" id="ref351">54</reflink>]],[[<reflink idref="bib55" id="ref352">55</reflink>]],[[<reflink idref="bib118" id="ref353">118</reflink>]],[[<reflink idref="bib229" id="ref354">229</reflink>]]</p> <p>Across the literature, web-based behavioural lifestyle modification in midlife women produced significant weight reduction up to -1.34 kg over 12 months.[[<reflink idref="bib225" id="ref355">225</reflink>]] On-site exercise sessions under the supervision of a trained interventionist resulted in greater weight loss than those produced by usual care (limited provision of dietary or activity advice and/or educational materials).[[<reflink idref="bib46" id="ref356">46</reflink>]],[[<reflink idref="bib116" id="ref357">116</reflink>]],[[<reflink idref="bib230" id="ref358">230</reflink>]] Only three studies reported a significant reduction in the visceral adipose tissue observed as a reduction in waist circumference.[[<reflink idref="bib116" id="ref359">116</reflink>]],[[<reflink idref="bib226" id="ref360">226</reflink>]] Limited studies assessed changes in metabolic parameters such as blood pressure, HbA1c, serum insulin, C-peptide, and HOMA-IR leading to inconclusive evidence on the role of comprehensive behavioural lifestyle intervention on improvement in metabolic status.[[<reflink idref="bib225" id="ref361">225</reflink>]],[[<reflink idref="bib230" id="ref362">230</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:25]</p> <p>Discussion</p> <p>The recommendations derived from the current systematic reviews and RCTs reveal that behavioural modification strategies have a crucial role in weight management programs.[[<reflink idref="bib115" id="ref363">115</reflink>]],[[<reflink idref="bib225" id="ref364">225</reflink>]],[[<reflink idref="bib228" id="ref365">228</reflink>]] Across the literature, a number of behavioural techniques were identified at different stages of weight management. Strategies such as setting realistic goals and motivational interviewing during initiation; problem-solving and cognitive restructuring during the intervention; self-monitoring and relapse prevention during the follow-up have proven to be effective.[[<reflink idref="bib54" id="ref366">54</reflink>]],[[<reflink idref="bib229" id="ref367">229</reflink>]] Initially, when patients are confronted with the need to change lifestyle-related behaviour they might face some ambivalence in incorporating this behaviour change. Healthcare providers can resolve this ambivalence through motivational interviewing, reflective listening and asking open-ended questions to stimulate involvement towards a behaviour change.[[<reflink idref="bib231" id="ref368">231</reflink>]] The counselling of problem-solving skills provides patients with an opportunity to discuss barriers experienced in day-to-day life for maintaining corrective dietary and activity behaviour.[[<reflink idref="bib55" id="ref369">55</reflink>]],[[<reflink idref="bib230" id="ref370">230</reflink>]] Problem solving skills include identifying the problem, finding possible solutions and adopting the best solution that can help in sustaining the corrective lifestyle habits for a long time period.[[<reflink idref="bib232" id="ref371">232</reflink>]] During follow-up sessions, self-monitoring of weight, diet and activity status should also be included as a key component for maintaining weight loss. Thus, a combination of behavioural approaches can be used in addition to lifestyle intervention for successful and sustainable weight loss outcomes.</p> <p>In clinical settings, weight loss programs focus only on prescribing corrective dietary and physical activity behaviours as primary modalities of weight loss. Healthcare providers should also consider incorporating behavioural modification strategies as an important modality of successful weight loss outcome.[[<reflink idref="bib223" id="ref372">223</reflink>]] Ideally, behavioural strategies should be advised by a trained behavioural therapist and/or psychologist. Often in healthcare settings, there is limited availability of dedicated behavioural therapists for weight management. Other healthcare providers should also be trained in providing preliminary behavioural strategies to mitigate barriers faced by midlife women for sustainable weight loss.</p> <p> <emph>3.5: What is the role of menopausal hormone therapy (MHT) in a weight management program for midlife women?</emph> </p> <p>Background</p> <p>Menopausal hormone therapy (MHT) is an effective treatment for the management of menopausal symptoms, especially for vasomotor and genitourinary symptoms. MHT is indicated in women with oestrogen deficiency. It is a systematic treatment with a group of preparations consisting of oestrogen and/or tibolone.[[<reflink idref="bib233" id="ref373">233</reflink>]] Almost 600 million women-years of MHT use have been reported in the period between 1970-2019.[[<reflink idref="bib234" id="ref374">234</reflink>]] Because there is high utilisation of MHT during the menopausal transition, it becomes important to understand its role in maintaining weight and health in midlife women. There is inconsistent literature on the effect of MHT use on body fat and changes in its distribution.[[<reflink idref="bib235" id="ref375">235</reflink>]] Besides, accelerated decline in lean muscle mass leading to sarcopenia has been associated with the menopausal transition. In midlife women using MHT, no positive or detrimental impact on muscle mass can be observed in the literature. In addition to alleviating menopausal symptoms, the possible health effects of MHT have been inconsistently reported across the literature.[[<reflink idref="bib236" id="ref376">236</reflink>]] Due to inconsistencies in literature it is important to realise the effect of MHT on weight status in midlife women undergoing lifestyle interventions. Hence, this clinical question was undertaken to understand the role of MHT in managing weight status, body composition and metabolic parameters in midlife women.</p> <p>Summary of evidence</p> <p>MHT has been evaluated in the management of osteoporosis, cognitive function, emotional volatility, sleep disturbances, cardiometabolic disorders and sexual dysfunction, especially in early menopausal women in the age group of 40 - 45 years.[[<reflink idref="bib237" id="ref377">237</reflink>]],[[<reflink idref="bib238" id="ref378">238</reflink>]] The International Menopause Society recommends customising and prescribing the lowest dose of hormone replacement drugs after considering the severity of menopausal symptoms, age of onset of menopause, family and personal history, route of administration and woman's preference.[[<reflink idref="bib238" id="ref379">238</reflink>]] In comparison to a conventional dose, low MHT doses led to a reduction in the levels of low-density lipoprotein (LDL), triglycerides and an increase in high-density lipoprotein (HDL). In addition, no effect on weight and corresponding BMI was observed in comparison to placebo.[[<reflink idref="bib239" id="ref380">239</reflink>]],[[<reflink idref="bib240" id="ref381">240</reflink>]] Only one prospective experimental study reported a reduction in body weight, fat mass and waist to hip ratio on the administration of oestradiol valerate plus dienogest at 6 and 12 months.[[<reflink idref="bib241" id="ref382">241</reflink>]] Similar inconsistencies have been reported on the protective role of MHT in the management of metabolic risk factors such as blood glucose, blood pressure, and serum lipid level in midlife women administered MHT in comparison to placebo.[[<reflink idref="bib242" id="ref383">242</reflink>]],[[<reflink idref="bib243" id="ref384">243</reflink>]] This calls for more research in this area of midlife health to provide conclusive recommendations on the impact of MHT on the body composition of midlife women.</p> <p>Clinical practice recommendations</p> <p>[INLINE:26]</p> <p>Discussion</p> <p>The recommendations suggest that MHT is not solely prescribed for weight management in midlife women. Experts believe that MHT is indicated in women with severe menopausal symptoms. The menopausal symptoms are known to impact the daily lifestyle of midlife women in a way that promotes weight gain. MHT should be primarily prescribed to manage menopausal symptoms severity, which in turn might improve the adherence towards healthy eating and activity behaviours, leading to better weight loss outcomes. Lifestyle modification should be recommended as the primary treatment modality in midlife women with overweight and obesity. The incorporation of corrective eating and activity behaviour can also help in mitigating the menopausal symptom severity and managing weight status.</p> <p>Section IV: Follow-up for Sustainable Weight Loss</p> <p> <emph>4.1: Which other parameters are of importance in determining the overall improvement in midlife women after undergoing weight management?</emph> </p> <p>Background</p> <p>Generally, most weight-loss interventions are primarily aimed at achieving clinically significant weight loss determined by a reduction of 5-10% from the baseline weight. The achievement of clinically significant weight loss through corrective lifestyle modification techniques is associated with improvement in cardiometabolic risk factors, obesity-related disease, menopausal and overall HRQoL in midlife women.[[<reflink idref="bib182" id="ref385">182</reflink>]] It is observed that a 10% reduction from body weight in an individual can promote significant improvement in circulating metabolic parameters including blood glucose, insulin, LDL, triglyceride and inflammatory markers such as C-reactive protein.[[<reflink idref="bib244" id="ref386">244</reflink>]] Some community-based interventions also aim at a reduction in waist circumference as an indicator for improvement in cardiometabolic health.[[<reflink idref="bib196" id="ref387">196</reflink>]],[[<reflink idref="bib245" id="ref388">245</reflink>]] Other anthropometric parameters such as skeletal muscle mass, lean muscle mass and bone mineral density are also important outcome measures for women transitioning towards menopause. The improvement in menopausal symptoms such as vasomotor symptoms and psychological distress is associated with enhanced overall HRQoL, especially in later years.[[<reflink idref="bib158" id="ref389">158</reflink>]] A comprehensive assessment of health-related outcome measures in addition to weight change is essential for understanding holistic health benefits associated with weight loss. However, the success of lifestyle modification intervention is mainly associated with weight loss. Hence, this clinical question was undertaken to identify the relevant outcome measures that should be taken into account to determine the success of a weight-loss intervention.</p> <p>Summary of evidence</p> <p>Across thirty-seven pertinent weight-loss trials, parameters such as anthropometric variables, cardiometabolic risk factors, bone mass density, menopausal symptoms, psychological distress and overall quality of life were assessed for improvement in women completing the lifestyle modification interventions. The most commonly assessed parameters were anthropometric variables including a reduction in fat mass or percentage body fat across 22 studies, followed by a reduction in visceral fat mass or waist circumference assessed in 15 studies.[[<reflink idref="bib66" id="ref390">66</reflink>]],[[<reflink idref="bib75" id="ref391">75</reflink>]],[[<reflink idref="bib196" id="ref392">196</reflink>]],[[<reflink idref="bib246" id="ref393">246</reflink>]] The increase in lean mass or muscle mass was an outcome measure in eleven studies.[[<reflink idref="bib111" id="ref394">111</reflink>]],[[<reflink idref="bib247" id="ref395">247</reflink>]],[[<reflink idref="bib248" id="ref396">248</reflink>]] The improvement in cardiometabolic risk factors such as HDL, LDL, fasting blood glucose was considered in ten weight loss trials.[[<reflink idref="bib80" id="ref397">80</reflink>]],[[<reflink idref="bib193" id="ref398">193</reflink>]],[[<reflink idref="bib210" id="ref399">210</reflink>]] The changes in satiety and hunger hormones were assessed in three studies.[[<reflink idref="bib82" id="ref400">82</reflink>]],[[<reflink idref="bib194" id="ref401">194</reflink>]],[[<reflink idref="bib207" id="ref402">207</reflink>]] Other parameters such as psychological distress in the form of anxiety, depression, insomnia, stress and quality of life were also assessed.[[<reflink idref="bib111" id="ref403">111</reflink>]],[[<reflink idref="bib212" id="ref404">212</reflink>]],[[<reflink idref="bib249" id="ref405">249</reflink>]],[[<reflink idref="bib250" id="ref406">250</reflink>]],[[<reflink idref="bib251" id="ref407">251</reflink>]] Three studies assessed improvement in bone mineral density and menopausal symptoms.[[<reflink idref="bib53" id="ref408">53</reflink>]],[[<reflink idref="bib75" id="ref409">75</reflink>]],[[<reflink idref="bib214" id="ref410">214</reflink>]],[[<reflink idref="bib252" id="ref411">252</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:27]</p> <p>Discussion</p> <p>Midlife women measure successful weight loss outcomes mainly in terms of achieving clinically significant weight loss.[[<reflink idref="bib253" id="ref412">253</reflink>]] Women should be sensitised regarding the role of weight loss in managing cardiometabolic, musculoskeletal, menopausal and mental health. In addition to weight, waist circumference as an outcome indicator of cardiometabolic health is easier to assess in public health and community settings. The cut-off values for biochemical parameters associated with cardiometabolic health are presented in Annexure 9. In addition to biochemical improvement, the changes in the clinical signs and symptoms related to menopausal health should also be evaluated post intervention. The improvement in menopausal symptoms such as joint pain and distress has been associated with improved compliance to corrective eating and activity behaviour. Clinicians should utilise improvement in health-related parameters as a motivator to maintain healthy eating and activity behaviour in the long term.[[<reflink idref="bib254" id="ref413">254</reflink>]] Hence, healthcare practitioners should consider weight management programs as an opportunity for improvement in overall health and quality of life in later years.</p> <p> <emph>4.2: What should be the duration, frequency and mode of follow-up for midlife women during the intervention?</emph> </p> <p>Background</p> <p>Regular and timely follow-ups is an integral component of a successful weight loss program. Considering that a substantial proportion of adults do not adhere to weight loss programs, providing supervision during intervention helps to facilitate adherence to corrective lifestyle-related behaviours. During the intervention, follow-up is an opportunity for healthcare providers to assess a patient's progress, evaluate health-related outcomes, mitigate barriers faced during weight management and customise lifestyle modification strategies.[[<reflink idref="bib255" id="ref414">255</reflink>]],[[<reflink idref="bib256" id="ref415">256</reflink>]]</p> <p>Follow-up meetings can be planned in individual or group sessions or combinations of both. Use of technology such as web-based follow-ups, text messages, motivational messages, or sending newsletters with recent updates can be utilised for maintaining appropriate contact with the patients.[[<reflink idref="bib257" id="ref416">257</reflink>]],[[<reflink idref="bib258" id="ref417">258</reflink>]],[[<reflink idref="bib259" id="ref418">259</reflink>]] Factors such as target weight loss goal, type of intervention (modality, duration, intensity) and level of adherence are associated with planning the follow-up during weight loss intervention. The frequency, mode and duration of follow-up varies across different types of weight-loss interventions.[[<reflink idref="bib260" id="ref419">260</reflink>]] However, the optimum duration, frequency and mode of follow-up to be planned for midlife women for achieving weight loss success has not been studied. Hence, this clinical question was undertaken to understand the effective combination of mode and frequency of follow-up during the intervention that can help in producing significant and sustainable weight loss outcomes.</p> <p>Summary of evidence</p> <p>The duration and frequency of follow-up were mentioned across 26 pertinent weight-loss trials; including two systematic reviews on weight maintenance.[[<reflink idref="bib261" id="ref420">261</reflink>]],[[<reflink idref="bib262" id="ref421">262</reflink>]] The total duration of follow-up ranged from 3 - 48 months.[[<reflink idref="bib67" id="ref422">67</reflink>]],[[<reflink idref="bib263" id="ref423">263</reflink>]] The most common follow-up duration was between 12 and 18 months reported across nine weight-loss trials. Long follow-up duration (≥ 30 months) was reported across six studies.[[<reflink idref="bib67" id="ref424">67</reflink>]],[[<reflink idref="bib260" id="ref425">260</reflink>]],[[<reflink idref="bib264" id="ref426">264</reflink>]],[[<reflink idref="bib265" id="ref427">265</reflink>]] Similar findings were reported by the two systematic reviews with a total follow-up duration ranging from 6 - 36 months for weight maintenance studies.[[<reflink idref="bib261" id="ref428">261</reflink>]],[[<reflink idref="bib262" id="ref429">262</reflink>]] As per one of the reviews, there was a vast difference in the frequency of contact made with the participants during the follow-up phase ranging from no/minimal contact to biweekly contact.[[<reflink idref="bib262" id="ref430">262</reflink>]] Similar findings were observed in independent weight-loss trials. The frequency of contact ranged from biannual to biweekly contact with the participants enrolled in the intervention group.[[<reflink idref="bib67" id="ref431">67</reflink>]],[[<reflink idref="bib257" id="ref432">257</reflink>]] In ten studies, a monthly contact was established with the participants. Some studies used a combination approach by establishing frequent contact at the initial intervention stage followed by limited contact at the later intervention stage.[[<reflink idref="bib260" id="ref433">260</reflink>]],[[<reflink idref="bib266" id="ref434">266</reflink>]] In the control groups, follow-up included no contact to web-based contact, contact via untrained staff and delivery of electronic health promotion material.[[<reflink idref="bib266" id="ref435">266</reflink>]],[[<reflink idref="bib267" id="ref436">267</reflink>]] The most common mode of contact was face-to-face, individualised sessions with a trained interventionist such as a dietitian, physician or behaviour therapist.[[<reflink idref="bib268" id="ref437">268</reflink>]],[[<reflink idref="bib269" id="ref438">269</reflink>]],[[<reflink idref="bib270" id="ref439">270</reflink>]] Group discussions as a mode of contact were opted by five studies and two studies each used telephonic, email and text messages as their way of maintaining follow-up contact with the participants.[[<reflink idref="bib271" id="ref440">271</reflink>]],[[<reflink idref="bib272" id="ref441">272</reflink>]],[[<reflink idref="bib273" id="ref442">273</reflink>]],[[<reflink idref="bib274" id="ref443">274</reflink>]]</p> <p>Clinical practice recommendations</p> <p>[INLINE:28]</p> <p>Discussion</p> <p>Regular contact with health care practitioners helps the patient to stay motivated and focused, improving the compliance towards corrective eating and activity advice.[[<reflink idref="bib275" id="ref444">275</reflink>]] The adherence to lifestyle practices is a key factor for improved weight loss outcomes.[[<reflink idref="bib276" id="ref445">276</reflink>]] Generally, the duration of the intervention is planned to achieve the target weight loss of 5-10% in six months. Follow-up is an important strategy for achieving target weight loss and long-term sustenance. A follow-up of 6 to 12 months is commonly considered for achieving the optimum weight loss goal. In addition to target weight loss, factors such as nature of the intervention, readiness to change, available social support and feasibility should be kept in mind while planning the follow-up meetings.[[<reflink idref="bib67" id="ref446">67</reflink>]],[[<reflink idref="bib268" id="ref447">268</reflink>]],[[<reflink idref="bib270" id="ref448">270</reflink>]]</p> <p>Weight loss achieved at the initial stage of the intervention is a key motivator of compliance and adherence to corrective lifestyle-related behaviours in the long term.[[<reflink idref="bib19" id="ref449">19</reflink>]] Frequent bimonthly follow-up sessions can be planned during the initial stages of intervention to achieve early weight loss and improve compliance. Further, frequent initial contact can help in providing information on corrective lifestyle habits and customise lifestyle interventions required for improving weight loss efforts.[[<reflink idref="bib255" id="ref450">255</reflink>]] This information can be provided using a combination of face-to-face sessions and technological modalities.[[<reflink idref="bib266" id="ref451">266</reflink>]],[[<reflink idref="bib268" id="ref452">268</reflink>]] With advanced technologies, the use of mobile applications for self-monitoring and providing real-time feedback can facilitate weight loss outcomes.[[<reflink idref="bib264" id="ref453">264</reflink>]] Mostly, a combination of individualised and technological sessions are planned across weight-loss interventions. Healthcare providers should identify the most feasible, interactive and sustainable method to maintain contact with midlife women enrolled for lifestyle modification.</p> <p> <emph>4.3: What should be the duration, frequency and mode of contact during the maintenance phase of the weight-management program for a midlife woman?</emph> </p> <p>Background</p> <p>The maintenance of lost weight is more challenging than achieving clinically significant weight loss across treatment modalities.[[<reflink idref="bib254" id="ref454">254</reflink>]] Weight maintenance is defined as a weight change of less than 3% for at least a period of one year.[[<reflink idref="bib277" id="ref455">277</reflink>]] Midlife women can experience fluctuations in weight status during the weight maintenance phase. Some common issues faced by midlife women during the maintenance phase are weight plateau, weight cycling, and relapse of lost weight.[[<reflink idref="bib278" id="ref456">278</reflink>]],[[<reflink idref="bib279" id="ref457">279</reflink>]] Studies suggest that regular contact of patients with healthcare providers helps in weight maintenance and long-term health-related outcomes.[[<reflink idref="bib255" id="ref458">255</reflink>]] Follow-up meetings during the maintenance phase can act as check points for adherence, compliance and challenges faced by the midlife woman. However, there are limited studies suggesting the frequency and duration of follow-up for effective weight maintenance. Hence, it is important to understand the best combination of duration, frequency and mode of follow-up for midlife women undergoing lifestyle intervention programs for successful long-term maintenance.</p> <p>Summary of evidence</p> <p>Across weight management trials, the duration of follow-up during the maintenance phase ranged from 3 to 48 months.[[<reflink idref="bib260" id="ref459">260</reflink>]],[[<reflink idref="bib263" id="ref460">263</reflink>]],[[<reflink idref="bib264" id="ref461">264</reflink>]] Most studies had a maintenance phase for 12 months.[[<reflink idref="bib257" id="ref462">257</reflink>]],[[<reflink idref="bib266" id="ref463">266</reflink>]],[[<reflink idref="bib267" id="ref464">267</reflink>]],[[<reflink idref="bib280" id="ref465">280</reflink>]],[[<reflink idref="bib281" id="ref466">281</reflink>]] Apart from the duration of follow-up, variation in the frequency and mode of contact with the patient was also observed. The frequency of follow-up in 26 maintenance studies ranged from biweekly to yearly follow-up visits. Most studies had a monthly follow-up visit along with different forms of contact using various technological modalities such as biweekly transmission of information using newsletters, weekly website logins, and telephonic calls with trained staff.[[<reflink idref="bib265" id="ref467">265</reflink>]] Group-based sessions were organised in five studies and others studies planned an individualised follow-up session.[[<reflink idref="bib67" id="ref468">67</reflink>]],[[<reflink idref="bib260" id="ref469">260</reflink>]],[[<reflink idref="bib266" id="ref470">266</reflink>]],[[<reflink idref="bib272" id="ref471">272</reflink>]] A study by Leahey <emph>et al</emph>.[[<reflink idref="bib267" id="ref472">267</reflink>]] also used monetary rewards for better follow-up and reduced dropout rates.</p> <p>Clinical practice recommendations</p> <p>[INLINE:29]</p> <p>Discussion</p> <p>Ideally, the follow-up of a woman achieving a weight loss target should be continued throughout her lifespan. The follow-up should include regular monitoring of parameters including weight status, lifestyle-related behaviours, cardiometabolic risk factors, menopausal and musculoskeletal health. Parameters such as BMI and waist circumference can be used as initial indicators to plan health care during maintenance.[[<reflink idref="bib282" id="ref473">282</reflink>]] In case of relapse of lost weight, the BMI, waist circumference and presence of cardiometabolic risk factors should be referred to plan the intensity of future care. The action-points at different anthropometric and health-related parameters during weight maintenance are shown in [Table 4.3.1]. Weight maintenance advice should include behavioural strategies to address the barriers faced by midlife women in maintaining corrective eating and activity habits required for weight loss. The weight management advice can be delivered through a combination of individualised and long-distance technology-based sessions as per the availability of resources. In addition to physical follow-up at three months, the use of technological modalities such as telephonic counselling, virtual counselling sessions, text messages, emails and social media groups have proven effective for weight maintenance.[INLINE:30]</p> <p> <emph>4.4: What advice should be given during the follow-up phase for maintenance of weight in midlife women?</emph> </p> <p>Background</p> <p>Weight maintenance aims at the management of physiological, behavioural, psychological and environmental factors to sustain weight in the long term.[[<reflink idref="bib283" id="ref474">283</reflink>]],[[<reflink idref="bib284" id="ref475">284</reflink>]] Even women who lose significant weight during the intervention phase find maintenance of weight through corrective eating and activity habits as difficult.[[<reflink idref="bib254" id="ref476">254</reflink>]] Weight maintenance counselling is an essential part of a sustainable weight management program.</p> <p>Weight maintenance advice includes adherence to healthy dietary habits, physically active routine, adequate sleep and other behavioural modifications important for further weight loss and/or weight maintenance.[[<reflink idref="bib261" id="ref477">261</reflink>]] These lifestyle habits should be reinforced to the patients at regular intervals during the maintenance phase to improve compliance towards a healthy lifestyle that can result in weight maintenance.[[<reflink idref="bib285" id="ref478">285</reflink>]] Behavioural modification strategies such as self-monitoring, problem-solving, relapse prevention, stimulus control and stress management should be considered as vital components of the counselling plan.[[<reflink idref="bib254" id="ref479">254</reflink>]],[[<reflink idref="bib286" id="ref480">286</reflink>]] Thus, a comprehensive plan should be devised to impart sustainable and successful weight maintenance advice among midlife women.</p> <p>Summary of evidence</p> <p>Weight maintenance advice can be extended to the participants after completion of the weight loss program with the aim to lose more weight, maintain the lost weight and prevent weight regain. The weight maintenance advice was based on dietary modification, the introduction of physical activity regime, cognitive behavioural therapy, social support, technological support and pharmacotherapy. In a systematic review, behavioural modification advice led to greater weight loss in comparison to pharmacological intervention. Six studies reported a combination of lifestyle modification with cognitive behavioural techniques to manage the challenges experienced during the weight maintenance phase.[[<reflink idref="bib67" id="ref481">67</reflink>]],[[<reflink idref="bib270" id="ref482">270</reflink>]],[[<reflink idref="bib281" id="ref483">281</reflink>]] Participants involved in new healthy behaviours during weight maintenance were able to maintain the lost weight for a longer duration in comparison to the control group following healthy dietary and activity habits.[[<reflink idref="bib67" id="ref484">67</reflink>]],[[<reflink idref="bib268" id="ref485">268</reflink>]],[[<reflink idref="bib271" id="ref486">271</reflink>]] Almost all studies included various forms of dietary modification advice for weight maintenance. Dietary advice for weight maintenance included low-calorie diets, meal replacement, alternate day fasting, replacing sweetened beverages with water, and reinforcement of healthy dietary habits.[[<reflink idref="bib258" id="ref487">258</reflink>]],[[<reflink idref="bib260" id="ref488">260</reflink>]],[[<reflink idref="bib261" id="ref489">261</reflink>]],[[<reflink idref="bib266" id="ref490">266</reflink>]],[[<reflink idref="bib268" id="ref491">268</reflink>]],[[<reflink idref="bib287" id="ref492">287</reflink>]] Some studies used key behavioural strategies for weight loss maintenance including problem-solving techniques, stimulus control, relapse prevention and overcoming barriers to healthy eating and physical activity provided across self-directed groups.[[<reflink idref="bib257" id="ref493">257</reflink>]],[[<reflink idref="bib265" id="ref494">265</reflink>]],[[<reflink idref="bib288" id="ref495">288</reflink>]] In five studies, the technological component was also compared with social support and positive reinforcement provided by a coach in the weight maintenance phase.[[<reflink idref="bib264" id="ref496">264</reflink>]],[[<reflink idref="bib267" id="ref497">267</reflink>]],[[<reflink idref="bib274" id="ref498">274</reflink>]] These interventions were associated with greater weight maintenance and less regain. The improvement in cardiometabolic risk factors such as fasting blood glucose, triglyceride, insulin and waist circumference were inconsistent across dietary interventions.[[<reflink idref="bib263" id="ref499">263</reflink>]],[[<reflink idref="bib264" id="ref500">264</reflink>]]</p> <p>Self-monitoring techniques were used to track the dietary habits, level of physical activity, weight, and behavioural change goals during the weight loss intervention or weight maintenance phase.[[<reflink idref="bib289" id="ref501">289</reflink>]],[[<reflink idref="bib290" id="ref502">290</reflink>]],[[<reflink idref="bib291" id="ref503">291</reflink>]],[[<reflink idref="bib292" id="ref504">292</reflink>]] Across studies, the self-monitoring techniques were used to regulate the dietary, activity, sleep and weight-related behaviours by providing personal feedback, health promotion education, maintaining contact with interventionist, peer group support and frequent behavioural prompters.[[<reflink idref="bib290" id="ref505">290</reflink>]],[[<reflink idref="bib293" id="ref506">293</reflink>]],[[<reflink idref="bib294" id="ref507">294</reflink>]],[[<reflink idref="bib295" id="ref508">295</reflink>]],[[<reflink idref="bib296" id="ref509">296</reflink>]] Four modes were identified for promoting self-monitoring techniques: digital platform, minimal digital platform, wearable technologies and non-digital platform or usual care.[[<reflink idref="bib297" id="ref510">297</reflink>]] Self-monitoring intervention most commonly uses digital platforms including mobile and web-based applications, text messages, and personal digital assistants followed by minimally used digital platforms including health promotion information, e-consultations, e-newsletter, email, etc. for regulating healthy lifestyle behaviours.[[<reflink idref="bib293" id="ref511">293</reflink>]],[[<reflink idref="bib298" id="ref512">298</reflink>]],[[<reflink idref="bib299" id="ref513">299</reflink>]],[[<reflink idref="bib300" id="ref514">300</reflink>]] The application-based dietary monitors tracked the amount of food and beverage consumed, daily calorie and fat intake, photographs of food items, bite counters and assigned a rating to foods consumed with comments and reviews from the interventionist.[[<reflink idref="bib264" id="ref515">264</reflink>]],[[<reflink idref="bib289" id="ref516">289</reflink>]],[[<reflink idref="bib301" id="ref517">301</reflink>]],[[<reflink idref="bib302" id="ref518">302</reflink>]] Physical activity was tracked by wearable technologies and applications, which provided insights on the daily duration of moderate physical activity, number of steps per day, and information on exercise plans.[[<reflink idref="bib294" id="ref519">294</reflink>]],[[<reflink idref="bib299" id="ref520">299</reflink>]],[[<reflink idref="bib303" id="ref521">303</reflink>]] Across systematic reviews and weight-loss trials, application-based self-monitoring strategies improved adherence to healthy dietary and activity advice.[[<reflink idref="bib290" id="ref522">290</reflink>]],[[<reflink idref="bib296" id="ref523">296</reflink>]],[[<reflink idref="bib297" id="ref524">297</reflink>]],[[<reflink idref="bib298" id="ref525">298</reflink>]] The improved adherence to healthy lifestyle habits for a longer duration contributed to a significant decrease in weight in application-based monitoring techniques in comparison to traditional monitoring techniques such as pen and paper-based daily diet and activity logs.[[<reflink idref="bib292" id="ref526">292</reflink>]],[[<reflink idref="bib293" id="ref527">293</reflink>]],[[<reflink idref="bib304" id="ref528">304</reflink>]] There is limited conclusive evidence on the impact of different combinations, durations and frequencies of digital self-monitoring techniques on weight loss outcomes.</p> <p>Clinical practice recommendations</p> <p>[INLINE:31]</p> <p>Discussion</p> <p>Lifestyle counselling acts as the cornerstone for sustainable weight management during the maintenance phase. Healthcare providers should reinforce compliance towards healthy dietary and activity practices using behavioural skills to prevent weight regain. Dietary strategies such as adequate protein intake, consumption of low glycemic foods, high fibre diet and low-fat dairy are associated with maintenance of weight.[[<reflink idref="bib189" id="ref529">189</reflink>]],[[<reflink idref="bib305" id="ref530">305</reflink>]] Patients should also be counselled to maintain an active lifestyle by including a combination of aerobic, resistance and balance exercises for at least 150 minutes/week.[[<reflink idref="bib306" id="ref531">306</reflink>]] The adherence to healthy eating and activity status should be facilitated by behavioural strategies such as problem-solving, stimulus control, and relapse prevention.[[<reflink idref="bib266" id="ref532">266</reflink>]],[[<reflink idref="bib268" id="ref533">268</reflink>]],[[<reflink idref="bib307" id="ref534">307</reflink>]]</p> <p>Self-monitoring is central to the process of weight maintenance and includes deliberate attention to dietary and activity behaviours, associated environmental cues and immediate and long-term health benefits.[[<reflink idref="bib308" id="ref535">308</reflink>]] Regular self-weighing is also a recommended strategy for weight maintenance. Self-weighing is defined as weighing oneself over a definite period of time such as daily, weekly or monthly.[[<reflink idref="bib309" id="ref536">309</reflink>]] Nowadays, the use of technical assistance through mobile and web-based applications, text messages, and personal digital assistants has proven effective for self-monitoring.[[<reflink idref="bib293" id="ref537">293</reflink>]],[[<reflink idref="bib297" id="ref538">297</reflink>]],[[<reflink idref="bib298" id="ref539">298</reflink>]],[[<reflink idref="bib299" id="ref540">299</reflink>]],[[<reflink idref="bib300" id="ref541">300</reflink>]] In addition to regular monitoring, healthcare providers should focus on providing frequent personalised feedback using technological aid.</p> <p>In literature, the individual and interactive impact of different lifestyle modification strategies in weight maintenance is lacking. Future research should also focus on factors associated with the management of overall health in association with maintenance of weight status.</p> <p>Discussion</p> <p>During midlife, women face multiple challenges that make them prone to weight gain, abdominal adiposity and poor HRQoL.[[<reflink idref="bib2" id="ref542">2</reflink>]],[[<reflink idref="bib6" id="ref543">6</reflink>]] There is a need to address these midlife-specific challenges to facilitate appropriate weight management in this group of women. To address these challenges, the experts from various fields came together to develop evidence and consensus-based guidelines for women-centric weight management in midlife women. The guidelines focus on clinical practice recommendations on behavioural lifestyle modification as first-line treatment of overweight and obesity in midlife women. In addition to lifestyle modification, areas specific to managing an adequate quality of life in midlife including metabolic, menopausal and musculoskeletal health was also included to provide a comprehensive treatment module.</p> <p>The guidelines include clinical practice points for healthcare providers to modify the existing dietary and activity behaviours in a way that promotes weight loss. The recommendations include stepwise assessment, management and monitoring of key dietary and activity behaviours to facilitate effective weight management. Dietary recommendations include counselling balanced dietary intake and corrective eating behaviours, focusing on macronutrient intake, consumption of HFSS foods and sugar sweetened beverages (SSBs), eating out and emotional eating. Physical activity recommendations help in customising a progressive exercise regime including aerobics, strength training, flexibility for managing weight, musculoskeletal and distress in midlife women. A mutually agreeable duration, intensity and frequency of exercise regime is important for long-term participation.[[<reflink idref="bib189" id="ref544">189</reflink>]] The recommendations also highlight different behavioural techniques including goal setting, problem-solving, managing triggers, and self-monitoring for sustainable weight loss. Behavioural modification can help in improving the compliance to corrective dietary and activity recommendations required to maintain ideal weight in the long term.[[<reflink idref="bib223" id="ref545">223</reflink>]] In clinical practice, the behavioural lifestyle modifications should be recommended in consideration with the maintenance of the overall health of midlife women.</p> <p>[INLINE:32]</p> <p>Benefit to healthcare fraternity</p> <p>The protocolised weight management module depicted in [Box 1] is a practical clinical tool for healthcare providers to deliver appropriate weight management in midlife women. Generally, healthcare providers encounter midlife women for other health-related issues such as diabetes, blood pressure, joint pain, and distress.[[<reflink idref="bib10" id="ref546">10</reflink>]] Healthcare providers should counsel midlife women regarding the role of managing weight as an effective strategy for maintaining overall health. They can also refer them to a multidisciplinary weight management team for customising a lifestyle modification approach.[[<reflink idref="bib57" id="ref547">57</reflink>]] The multidisciplinary team can use the recommendations to facilitate a well-rounded approach in the management of obesity and associated adiposity-related comorbidities.[INLINE:33]</p> <p>In resource-constrained settings, the availability of experts from multidisciplinary teams might be limited.[[<reflink idref="bib310" id="ref548">310</reflink>]] The clinician and/or healthcare provider encountering midlife women with obesity are required to provide obesity care.[[<reflink idref="bib311" id="ref549">311</reflink>]] Mostly, midlife women visit primary care physicians, family physicians, internists, gynaecologists, endocrinologists, and orthopaedicians for other health-related issues.[[<reflink idref="bib312" id="ref550">312</reflink>]] The recommendations provide clinical practice points for opportunistic screening and management of obesity in midlife women that can be incorporated by clinicians and allied healthcare providers from different healthcare specialties in their daily clinical practice.</p> <p>Further, a significant proportion of women belonging to lower socio-economic strata and/or residing in rural settings might have access only to local primary healthcare centres and <emph>anganwadi</emph>. These healthcare settings offer suboptimal obesity care due to a lack of multidisciplinary teams, resources and time.[[<reflink idref="bib313" id="ref551">313</reflink>]] The woman's preference to initiate weight loss, motivation, education status, access to resources, daily lifestyle and income level becomes important in determining the appropriate weight management approach. The protocolised treatment plan supplemented with health education material can help the primary care provider to initiate optimum obesity care with limited resource availability.</p> <p>The recommendations can help in capacity building by providing evidence and consensus-based weight management practices at both clinical and community level. The clinical practice recommendations are simple, practical, and actionable statements to manage obesity in midlife women. This will ensure uniform and appropriate obesity treatment practices for midlife women within various healthcare settings.</p> <p>The guideline promotes preventive obesity care in midlife women. The current guideline highlights the following key areas: when to initiate and engage midlife women for weight management, who should provide obesity care, and which mode should be used to deliver healthcare. These recommendations promote a proactive approach in managing obesity-related disorders in midlife women. The practical application of these guidelines can help to manage the ever-growing burden of obesity and associated cardiometabolic diseases in different healthcare systems of the country.</p> <p>Suggestions for policy-makers</p> <p>A substantial increase in the prevalence of overweight and obesity, especially in rural residents and older adults is projected in India by 2040.[[<reflink idref="bib314" id="ref552">314</reflink>]] The policy makers should disseminate recommended clinical practice points at medical, curriculum and public health levels to manage the burden of obesity and allied comorbidities. The policy makers should ensure resources for the application of the evidence-based clinical practice points at different levels of healthcare settings. The clinicians and allied healthcare professionals should be provided with knowledge regarding appropriate obesity care including lifestyle modification, pharmacological and surgical interventions. Healthcare providers in resource-constrained settings should be appraised about the additional challenges in managing obesity. In addition, the practitioners should empower midlife women with the knowledge related to appropriate eating, physical activity and other lifestyle-related behaviours through providing health education material (like posters, brochures, newsletters, etc.), providing necessary and appropriate referrals and managing support groups at the clinical settings. Healthcare settings should establish 'women wellness clinics' for multidisciplinary management of obesity and allied health disorders and ensure active and regular participation of the clinicians from different specialties and allied healthcare professionals.</p> <p>In addition to caregivers, midlife women should also be empowered with the correct knowledge to maintain healthy lifestyle-related behaviours. These women experience a number of biopsychosocial changes. Poor health literacy at this stage hampers the ability of midlife women to understand and implement health-related information to manage overall health.[[<reflink idref="bib315" id="ref553">315</reflink>]] The promotion of the use of artificial intelligence to support weight loss-related behaviour change in adults through improving self-regulation, decision making, problem-solving and pattern identification can help in improving KAP of midlife women towards weight management. The policy makers should introduce policies and programs to educate midlife women experiencing menopausal transitions and associated health implications including weight gain, musculoskeletal and cardiometabolic health. Some initiatives like Club 35+, and Midlife Healthcare Clinics taken up by the Indian Menopausal Society can be replicated to empower midlife women with appropriate medical advice with the support of healthcare professionals.</p> <p>Policy makers should use mass-media campaigns to transform weight-related behaviour. This will help in exposing a significant proportion of women with corrective weight-related information using print media (leaflets, posters, brochures) and social media (websites, newsletters, television). These campaigns focus on simple and actionable corrective eating behaviours such as consumption of milk, pulses and fruits and vegetables, optimum water intake and limited consumption of HFSS foods.[[<reflink idref="bib316" id="ref554">316</reflink>]] Generally, campaigns promote regular participation in physical activities like walking, jogging, dancing and aerobics. Although campaigns promote positive health behaviours in the short term, often their results do not translate in the long term due to competing cues for unhealthy behaviours enforced by an obesogenic environment.[[<reflink idref="bib317" id="ref555">317</reflink>]] Hence, a more comprehensive and integrated approach is required to help address overweight and obesity in midlife women, as has been discussed in this document.</p> <p>Statement</p> <p>Considering its potential for widespread public health impact and general interest, the guidelines in multiple versions (comprehensive, concise, executive summary, good clinical practice points) have been submitted for simultaneous publication and/or co-publication (either fully or a part of it) in Diabetes and Metabolic Syndrome: Clinical Research and Reviews, National Medical Journal of India, Journal of Midlife Health, Journal of Family Medicine and Primary Care, JAPI: Journal of the Association of Physicians of India, and Indian Journal of Medical Specialities Journal of Obstetrics and Gynaecology of India. The guidelines can be submitted to some more journals for publication. Besides, the guidelines can be published on the government's website and AIIMS, New Delhi's website.</p> <p>Acknowledgements</p> <p>The guidelines have been developed in association with the following National Bodies and Societies : (i) Federation of Obstetric and Gynaecological Societies of India, (ii) Indian Menopause Society, (iii) Association of Physicians of India, (iii) Academy of Family Physicians of India, (iv) Association of Obstetricians & Gynaecologists of Delhi and (v) Indian Dietetic Association.</p> <p>Financial support and sponsorship</p> <p>The study was financially supported by the SEED Division, Department of Science and Technology, Government of India.</p> <p>Conflicts of interest</p> <p>There are no conflicts of interest.</p> <p>Annexures</p> <p>[INLINE:34]</p> <p>[INLINE:35]</p> <p>[INLINE:36]</p> <p>[INLINE:37]</p> <p>[INLINE:38]</p> <p>[INLINE:39]</p> <p>[INLINE:40]</p> <p>[INLINE:41]</p> <p>[INLINE:42]</p> <p>[INLINE:43]</p> <ref id="AN0161723669-2"> <title> REFERENCES </title> <blist> <bibl id="bib1" idref="ref1" type="bt">1</bibl> <bibtext> Garawi F, Devries K, Thorogood N, Uauy R. 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  Data: Evidence and consensus-based clinical practice guidelines for management of overweight and obesity in midlife women: An AIIMS-DST initiative
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  Data: Journal of Family Medicine and Primary Care, Vol 11, Iss 12, Pp 7549-7601 (2022)
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  Data: Wolters Kluwer Medknow Publications, 2022.
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