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, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (1:1) 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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    Titel :

    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


    Beteiligte:
    King, Carina (Autor:in) / Pires, Malini (Autor:in) / Ahmed, Naveed (Autor:in) / Akter, Kohenour (Autor:in) / Kuddus, Abdul (Autor:in) / Copas, Andrew (Autor:in) / Haghparast-Bidgoli, Hassan (Autor:in) / Morrison, Joanna (Autor:in) / Nahar, Tasmin (Autor:in) / Shaha, Sanjit Kumer (Autor:in)

    Erscheinungsdatum :

    2023-03-23


    Anmerkungen:

    Trials , 24 , Article 218. (2023)


    Medientyp :

    Aufsatz (Zeitschrift)


    Format :

    Elektronische Ressource


    Sprache :

    Englisch



    Klassifikation :

    DDC:    629