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 randomised 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 54.7 (SD 10.0) years old and 64.8% were male. Majority of participants (74.5%) were Chinese, 6.8% Malay and 17.0% Indian. 66.6% had a monthly income of SGD$4,000 or more. The mean baseline HbA1c was 8.13% (SD 0.97) and mean Body Mass Index was 27kg.0/m2 (SD 5.6).
Discussion: The final participant will finish follow-up data collection by 30 June 2023. At this time all pre-planned analyses will be conducted and final results reported.
Trial registration: Registered on clinical trials.gov (NCT03800680) on 11 January 2019, accessible via https://clinicaltrials.gov/ct2/show/NCT03800680