Protocol update and baseline characteristics for the TRIal to slow the Progression of Diabetes (TRIPOD) randomized controlled trial

Author:

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 AndrewORCID

Abstract

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.

Funder

National Medical Research Council

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

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