Bibliographic Details
| Title: |
Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized controlled trial. |
| Authors: |
Bairavi, Joann, Gardner, Daphne Su-Lyn, Yeoh, Ester, Tham, Kwang Wei, Gandhi, Mihir, Tan, Ngiap Chuan, Lee, Phong Ching, Lim, Robyn Su May, Adamjee, Thofique, Cheung, Yin Bun, Bee, Yong Mong, Finkelstein, Eric Andrew |
| Source: |
Trials; 11/14/2023, Vol. 24 Issue 1, p1-7, 7p |
| Subject Terms: |
PEDOMETERS, TYPE 2 diabetes, INCOME, DISEASE risk factors, BODY mass index, DIABETES |
| Geographic Terms: |
SINGAPORE |
| Abstract: |
Background: Type 2 diabetes (T2D), a major risk factor for cardiovascular disease and other adverse health conditions, is on the rise in Singapore. TRIPOD is a randomized controlled trial aimed to determine whether complementing usual care with an evidence-based diabetes management package (DMP) —comprising access to an evidence-based app, health coaching, pedometer, glucometer and weighing scale, with or without a financial rewards scheme (M-POWER rewards), can improve mean HbA1c levels at months 6 and 12. Methods: The protocol was published in Trials, accessible via https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3749-x1. This manuscript updates the protocol with changes to the study design due to challenges with recruitment and presents baseline characteristics. Key updates include changing the arm allocation ratio from 1:1:1 (Arm 1-Usual Care: Arm 2-DMP: Arm 3-DMP+M-POWER rewards) to 10:1:10, the sample size from 339 to 269, the intervention period from two to one year, and the primary hypothesis to focus solely on differences between Usual Care and DMP+M-POWER rewards. Recruitment for the study began on 19 October 2019 and ended on 4 June 2022. Results: The average age of participants was 55.0 (SD9.7) years old and 64.2% were male. The majority of participants (76.8%) were Chinese, 4.9% Malay and 18.3% Indian and of other ethnicities. 67.0% had a monthly household income of SGD$4000 or more. The mean baseline HbA1c was 8.10% (SD 0.95) and the mean body mass index was 26.8 kg/m2 (SD 5.3). Discussion: The final participant completed month 12 follow-up data collection on 8 June 2023. All pre-planned analyses will be conducted and final results reported. Trial registration: ClinicalTrials.govNCT03800680. Registered on 11 January 2019. [ABSTRACT FROM AUTHOR] |
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| Database: |
Complementary Index |
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