Dataset Information

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

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 HbA_1c 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 HbA_1c 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.

SUBMITTER: Bairavi J

PROVIDER: S-EPMC10647071 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Bairavi Joann J Gardner Daphne Su-Lyn DS Yeoh Ester E Tham Kwang Wei KW Gandhi Mihir M Tan Ngiap Chuan NC Lee Phong Ching PC Lim Robyn Su May RSM Adamjee Thofique T Cheung Yin Bun YB Bee Yong Mong YM Finkelstein Eric Andrew EA

Trials 20231114 1

<h4>Background</h4>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 HbA<sub>1c</s ...[more]

PMID: 37964330

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Dataset Information

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

Background

Methods

Results

Discussion

Trial registration

Publications

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

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