Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare trial): study protocol for a stepped-wedge cluster randomised controlled trial

Abstract

Background An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the ‘Diabetes: Community-led Awareness, Response and Evaluation’ (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. Methods This is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 to September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18 months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga Upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-h post-glucose load blood tests. A total of 4680 participants provide 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and an ICC of 0.07. The analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. Discussion This study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the stepped-wedge design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. Trial registration ISRCTN: ISRCTN42219712. Registered on 31 October 2019

Changes in non-communicable diseases, diet and exercise in a rural Bangladesh setting before and after the first wave of COVID-19

“…We conducted an opportunistic before-after study, using two cross-sectional surveys conducted from February to March 2020 (survey 1), and January to March 2021 (survey 2) in Faridpur District, Bangladesh. The surveys form the baseline for the D:Clare trial, a randomised controlled trial of a community-based participatory learning and action intervention to reduce T2DM (ISRCTN 42219712) [20]. The trial was interrupted in March 2020, and resumed in January 2021 with a new baseline survey, allowing us to compare population T2DM and other NCD prevalence and risks immediately before the pandemic was declared in Bangladesh, and one year later.…”

“…The study is based in Alfadanga upazilla (sub-district), Faridpur district, with an approximate population of 120,000. The setting was purposefully selected for the D:Clare trial as it had not previously been exposed to the intervention, is less prone to flooding and is close to a field office [20]. Alfadanga is generally reflective of a 'typical' rural context, with an agricultural economy, and majority Bengali and Muslim population.…”

“…At each survey, a new sample of households and individuals was generated, and some individuals may be sampled in both surveys by chance. The sample for the first survey was 1320 and 1584 for the second survey, according to the D:Clare trial which assumed a baseline prevalence of increased blood glucose of 40% and power to detect a 30% reduction [20].…”

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

“…Our original SW design had two-steps and was planned to take 30 months, with cross-sectional surveys done at project month 6, 18 and 30 (Figure 1). 1 The SW design should be resilient to temporal changes within a population, and so our original approach remained valid. However, the interruption of activities and the nature of the COVID-19 pandemic meant this design was no longer be the most e cient and appropriate to meet project goals, and we presented alternative options to our Trial Steering Committee for consideration.…”

“…The D:Clare Trial (Diabetes: Community-Led Awareness, Response and Evaluation) was designed as a cluster randomised stepped-wedge trial, in Alfadanga Upazilla, Faridpur District, Bangladesh (ISRCTN42219712). 1 The trial aims to evaluate the impact of a scaled-up community-based participatory learning and action (PLA) cycle intervention to prevent type-2 diabetes (T2DM) in a population 120,000 people. The trial began in January 2020, with a public consent and randomisation ceremony including community and Ministry of Health and Family Welfare representatives, on the grounds that all communities in the Upazilla would eventually receive the intervention in-line with the stepped-wedge approach.…”