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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
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...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10034243/ https://www.ncbi.nlm.nih.gov/pubmed/36959617 http://dx.doi.org/10.1186/s13063-023-07243-x |
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author | 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 |
author_facet | 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 |
author_sort | King, Carina |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10034243 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-100342432023-03-23 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 Trials Update 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. BioMed Central 2023-03-23 /pmc/articles/PMC10034243/ /pubmed/36959617 http://dx.doi.org/10.1186/s13063-023-07243-x Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Update 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 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Update |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10034243/ https://www.ncbi.nlm.nih.gov/pubmed/36959617 http://dx.doi.org/10.1186/s13063-023-07243-x |
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