PMID- 33781315 OWN - NLM STAT- MEDLINE DCOM- 20210617 LR - 20240313 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 22 IP - 1 DP - 2021 Mar 29 TI - 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. PG - 235 LID - 10.1186/s13063-021-05167-y [doi] LID - 235 AB - 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. FAU - King, Carina AU - King C AUID- ORCID: 0000-0002-6885-6716 AD - Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK. carina.king@ki.se. AD - Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. carina.king@ki.se. FAU - Pires, Malini AU - Pires M AD - Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK. FAU - Ahmed, Naveed AU - Ahmed N AD - Diabetic Association of Bangladesh, Dhaka, Bangladesh. FAU - Akter, Kohenour AU - Akter K AD - Diabetic Association of Bangladesh, Dhaka, Bangladesh. FAU - Kuddus, Abdul AU - Kuddus A AD - Diabetic Association of Bangladesh, Dhaka, Bangladesh. FAU - Copas, Andrew AU - Copas A AD - Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK. FAU - Haghparast-Bidgoli, Hassan AU - Haghparast-Bidgoli H AD - Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK. FAU - Morrison, Joanna AU - Morrison J AD - Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK. FAU - Nahar, Tasmin AU - Nahar T AD - Diabetic Association of Bangladesh, Dhaka, Bangladesh. FAU - Shaha, Sanjit Kumer AU - Shaha SK AD - Diabetic Association of Bangladesh, Dhaka, Bangladesh. FAU - Khan, A K Azad AU - Khan AKA AD - Diabetic Association of Bangladesh, Dhaka, Bangladesh. FAU - Azad, Kishwar AU - Azad K AD - Diabetic Association of Bangladesh, Dhaka, Bangladesh. FAU - Fottrell, Edward AU - Fottrell E AD - Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK. LA - eng GR - MR/M016501/1/MRC_/Medical Research Council/United Kingdom GR - MR/T023562/1/MRC_/Medical Research Council/United Kingdom PT - Clinical Trial Protocol PT - Journal Article DEP - 20210329 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Bangladesh/epidemiology MH - Cluster Analysis MH - Community Participation MH - Cross-Sectional Studies MH - *Diabetes Mellitus, Type 2/diagnosis/epidemiology/prevention & control MH - Humans MH - Randomized Controlled Trials as Topic MH - Rural Population PMC - PMC8006505 OTO - NOTNLM OT - Bangladesh OT - Diabetes OT - Non-communicable diseases OT - Participatory learning and action OT - Stepped-wedge trial OT - T2DM COIS- The authors declare that they have no competing interests. EDAT- 2021/03/31 06:00 MHDA- 2021/06/22 06:00 PMCR- 2021/03/29 CRDT- 2021/03/30 05:57 PHST- 2020/10/19 00:00 [received] PHST- 2021/03/02 00:00 [accepted] PHST- 2021/03/30 05:57 [entrez] PHST- 2021/03/31 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2021/03/29 00:00 [pmc-release] AID - 10.1186/s13063-021-05167-y [pii] AID - 5167 [pii] AID - 10.1186/s13063-021-05167-y [doi] PST - epublish SO - Trials. 2021 Mar 29;22(1):235. doi: 10.1186/s13063-021-05167-y.