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Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized
Joann Bairavi1, Daphne Su-Lyn Gardner2, Ester Yeoh3
1Health Services & Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.
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-x 1. 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.gov NCT03800680 . Registered on 11 January 2019.
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