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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.
King, Carina; Pires, Malini; Ahmed, Naveed; Akter, Kohenour; Kuddus, Abdul; Copas, Andrew; Haghparast-Bidgoli, Hassan; Morrison, Joanna; Nahar, Tasmin; Shaha, Sanjit Kumer; Khan, AKAzad; Azad, Kishwar; Fottrell, Edward.
  • King C; Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK.
  • Pires M; Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.
  • Ahmed N; Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK.
  • Akter K; Diabetic Association of Bangladesh, Dhaka, Bangladesh.
  • Kuddus A; Diabetic Association of Bangladesh, Dhaka, Bangladesh.
  • Copas A; Diabetic Association of Bangladesh, Dhaka, Bangladesh.
  • Haghparast-Bidgoli H; Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK.
  • Morrison J; Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK.
  • Nahar T; Institute for Global Health, University College London, 30 Guildford Street, London, WC1N 1EH, UK.
  • Shaha SK; Diabetic Association of Bangladesh, Dhaka, Bangladesh.
  • Khan A; Diabetic Association of Bangladesh, Dhaka, Bangladesh.
  • Azad K; Diabetic Association of Bangladesh, Dhaka, Bangladesh.
  • Fottrell E; Diabetic Association of Bangladesh, Dhaka, Bangladesh.
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.
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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

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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