Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (DClare): an updated study protocol for a parallel arm cluster randomised controlled trial

Abstract

The “Diabetes: Community-led Awareness, Response and Evaluation” (D:Clare) 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, from March 2020 – September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at project 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 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 (https://doi.org/10.1186/ISRCTN42219712). Registration date: 31/10/2019.