Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare): an updated study protocol for a parallel arm cluster randomised controlled trial.
Trials
; 24(1): 218, 2023 Mar 23.
Article
in English
| MEDLINE | ID: covidwho-2266553
ABSTRACT
The "Diabetes Community-led Awareness, Response and Evaluation" (DClare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control.The trial was originally designed as a stepped-wedge cluster randomised controlled trial, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (11) to implement the intervention at months 1 or 12 in two steps, and evaluated through three cross-sectional surveys at months 1, 12 and 24. However, due to the COVID-19 pandemic, we suspended project activities on the 20th of March 2020. As a result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we changed from the stepped-wedge design to a wait-list parallel arm cluster RCT (cRCT) with baseline data. We had four key reasons for eventually agreeing to change designs equipoise, temporal bias in exposure and outcomes, loss of power and time and funding considerations.Trial registration ISRCTN42219712 . Registered on 31 October 2019.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Diabetes Mellitus, Type 2
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2023
Document Type:
Article
Affiliation country:
S13063-023-07243-x
Similar
MEDLINE
...
LILACS
LIS