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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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trial Carina King, Malini Pires, Naveed Ahmed, Kohenour Akter, Abdul Kuddus, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-1665799/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 23 Mar, 2023 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract 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, from March 2020 – September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at project 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 20 th 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 (https://doi.org/10.1186/ISRCTN42219712). Registration date: 31/10/2019. Diabetes non-communicable diseases Bangladesh participatory learning and action stepped-wedge trial cluster RCT Figures Figure 1 Figure 2 Full Text 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. Bangladesh reported its first confirmed cases of SARS-CoV-2 on the 8 th March. Due to concerns about infection risk to both staff and communities, we made a decision to suspend all field-based project activities on the 20 th March 2020 ( Figure 1 ). Early in the pandemic, evidence emerged that uncontrolled hyperglycaemia and type 2 diabetes (T2DM) were risks for severe COVID-19 infections and mortality, alongside older age, obesity and heart disease. 2-4 Given the focus and nature of our PLA intervention, we were therefore particularly conscious that continuing the trial may have increased risks amongst vulnerable populations with non-communicable diseases. The status of the trial at the point of suspension is summarised in Table 1 . Bangladesh subsequently entered into a nationwide government declared lockdown from the 23 rd March to 30 th May 2020, and restrictions on mass gatherings continued until 1 st September 2020. 5 The second serious COVID-19 wave began in March 2021, and lockdowns were again implemented between 5 th April - 21 st April 2021 and 1 st July – 11st August 2021. This short article summarises the changes to our original trial design whilst detailing the considerations and rationale for these changes, which may be of relevance to other randomised controlled trials underway in dynamic contexts. Change In Trial Design As the result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we decided to change from a stepped-wedge (SW-RCT) to a wait-list parallel arm cluster RCT (cRCT) with baseline data. Conceptually, our wait-list design is a parallel arm cRCT but with commitment to implement the intervention to control clusters at the end of the trial evaluation. As detailed in Table 2 , this differs from our stepped-wedge trial design in terms of the timing of roll-out of the intervention across all clusters, timing of cross-sectional data collection for evaluation, and in terms of how clusters are exposed over time, i.e. the allocated exposure (intervention or control) does not change during the trial evaluation. 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 efficient and appropriate to meet project goals, and we presented alternative options to our Trial Steering Committee for consideration. We had four key reasons for eventually agreeing to change designs. Equipoise The D:Clare PLA intervention was shown to be effective in reducing both the 2-year cumulative incidence and prevalence of T2DM in a rural Bangladesh population during the D-Magic trial. 6 This was part of the justification for us using a SW-RCT originally, as evidence of population benefit existed, and our aim was to determine effectiveness at-scale in a similar but new population. However, with the considerable change in context and potential need to adapt the intervention components and delivery, the lack of equipoise around the PLA intervention we had previously argued was less clear. Specifically, our intervention encourages groups to meet, encourages participation from those with T2DM and NCDs and encourages collective action. In a context where COVID-19 preventive measures focused on restricting inter-household interactions, we hypothesised that PLA’s mechanism of action may be affected. Further, if COVID-19 cases were not being diagnosed in this community setting, then group meetings had the potential to cause harm. However, by the end of 2020 there was evidence that outdoor environments posed a lower risk of transmission than indoor, crowded spaces, especially if this can be combined with the use of face masks, hand hygiene and physical distancing. Given the potential for our intervention to improve T2DM management (a key risk for poor COVID-19 outcomes), the ability to deliver in a way that would reduce transmission, and inclusion of new stop/start rules ( Figure 2 ), we felt this risk could be sufficiently mitigated. We therefore decided we met the criteria for equipoise around the intervention needed to do a parallel group cluster RCT. Temporal bias in exposure and outcomes We also hypothesised that post-COVID-19 health literacy, care-seeking, dietary and physical activity behaviours, and the epidemiology of diabetes could be vastly different after lockdown restrictions were lifted – and therefore from our baseline survey. This in itself should not invalidate the SW-RCT design, but could make interpretation and communication of the intervention impact on primary and secondary outcomes more complicated. The timing of intervention delivery relative to lockdown and social distancing measures was also likely to have an important influence on the uptake, delivery and effectiveness of the intervention. This may result in variable intervention effects between the two steps of SW implementation, which could be assessed through process evaluation, but again would complicate interpretation. Loss of power Our power calculation was based on achieving at least an 80% response in the first cross-sectional survey. However, we only achieved 72% recruitment at the time of interruption, and saw variation in rates between clusters (49% - 89%). In order to then ensure the SW-RCT was sufficiently powered, we would have had to increase the sample size of all the subsequent surveys. Switching to a parallel arm trial which uses both a new baseline and endline data (assuming an autocorrelation of 0.4), we could achieve 78% power for a 30% reduction in the primary outcome and considered this a feasible alternative. The change to the number and timing of surveys and inclusion of baseline data in outcome evaluation are notable changes to our original protocol (Table 2). Time and funding Finally, there was a very practical issue that we no longer had enough time to complete the SW-RCT design within the overall 36-month funded project period, using our 12-month staggered two-step design. By switching to a parallel cRCT we could complete the effectiveness evaluation within the funded project timeline, albeit answering a slightly different evaluation question. We then planned to source project extensions and resources to scale-up the intervention into the control clusters as was promised to communities, but without incurring on-going concurrent process, economic and impact evaluation costs. Protocol Updates We made changes to three key areas of the trial protocol: study design, intervention and sample size; no amendments were made to the trial procedures for population eligibility, sampling, randomisation, blinding, data collection, or analysis of the primary or secondary outcomes. A list of registered trial protocol amendments in our ISRCTN record are summarised in Box 1 . We also set-out COVID-19 standard operating procedures, with new stop-start rules ( Figure 2 ), a COVID-19 safety protocol for staff and study participants, and consulted with a Data Monitoring and Safety Board on these infection prevention measures. For the intervention, we made the following modifications to incorporate COVID-19 measures: holding two meetings per village per month to allow for smaller groups but with the same coverage; inclusion of COVID-19 health information; re-organised meeting content to be delivered over a minimum of 13 instead of the planned 18 meetings (Table 2). Current Trial Status As of the 22/04/2022: We completed a new baseline survey on the 25/02/2021, with a response rate of 1,392 from 1,584 (87.9%) sampled participants, which forms the parallel arm cRCT baseline data. A total of 213 PLA groups have been formed in 6 of the 12 study clusters, and have completed 11 of a minimum 13 planned meetings. The endline survey will be completed between August and October 2022. Protocol version 3.0 (16/06/2021) Abbreviations D:Clare: (Diabetes: Community-Led Awareness, Response and Evaluation) NCD: non-communicable disease PLA: participatory learning and action RCT: randomised controlled trial SW-RCT: stepped-wedge randomised controlled trial T2DM: type-2 diabetes mellitus Declarations Ethics approval and consent to participate: Written informed consent will be obtained from all survey and interview participants by study staff. Community consent was sought from community leaders prior to randomisation and intervention implementation. Ethical approvals were provided by University College London Research Ethics Committee (ref: 4199/007) and the Ethical Review Committee of the Diabetic Association of Bangladesh (ref: BADAS-ERC/E/19/00276). Consent for publication: Not applicable. Availability of data and materials: Data required to support the protocol can be supplied on request. Competing interests: The authors declare no competing interests. Funding: The trial is funded by the UK Medical Research Council (ref: MR/T023562/1) under the Global Alliance for Chronic Diseases (GACD) Diabetes Programme. Peer review of the grant application provided input into the study proposal. Beyond that, the funder has no role in the design of the study, data collection, analysis and interpretation, or the write-up of the findings. Authors' contributions: EF is the principal investigator. He led the design of the study, wrote the first draft of the study protocol, and will participate in the analysis and interpretation of data. AK is project manager of the trial, overseeing all activities. CK is a senior researcher on the project, supporting the design, analysis and interpretation of data, and overseeing the data collection and management system. MP is research assistant on the study, contributing to design, analysis and interpretation of data. JM is a senior researcher on the project, leading design, analysis and interpretation of the process evaluation. HHB is senior researcher on the project, leading the economic evaluation and equity components. AC is the trial statistician, and contributed to the design of the study and will participate in the analysis and interpretation of data. NA contributed to protocol development, fieldworker training, and development of interventions. SKS coordinates survey data collection and processes and will participate in the analysis and interpretation of data. TN contributed to the design of interventions and is responsible for intervention implementation. KAk contributed to the design of the process evaluation. AKAK provides technical oversight. KAz is project director, contributed to the design of the study, leads the implementation of the trial and will participate in interpretation of data. All authors read and approved the final manuscript. Acknowledgements: We thank the members of our trial steering committee: Dr David Beran (Chair), Prof Graham Hitman, Prof Sarah Hawkes, Prof Anthony Costello, Prof Edward Gregg, Dr Jennifer Thompson, Prof Audrey Prost, Prof Justine Davies. We would also like to acknowledge the communities and community leaders for their engagement with the project. References King C, Pires M, Ahmed N, et al. 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. Trials . 2021/03/29 2021;22(1):235. doi:10.1186/s13063-021-05167-y Zhu L, She Z-G, Cheng X, et al. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metabolism . 2020/06/02/ 2020;31(6):1068-1077.e3. doi:https://doi.org/10.1016/j.cmet.2020.04.021 Ho FK, Petermann-Rocha F, Gray SR, et al. Is older age associated with COVID-19 mortality in the absence of other risk factors? General population cohort study of 470,034 participants. PLOS ONE . 2020;15(11):e0241824. doi:10.1371/journal.pone.0241824 Mesas AE, Cavero-Redondo I, Álvarez-Bueno C, et al. Predictors of in-hospital COVID-19 mortality: A comprehensive systematic review and meta-analysis exploring differences by age, sex and health conditions. PLOS ONE . 2020;15(11):e0241742. doi:10.1371/journal.pone.0241742 Siam MHB, Hasan MM, Tashrif SM, Rahaman Khan MH, Raheem E, Hossain MS. Insights into the first seven-months of COVID-19 pandemic in Bangladesh: lessons learned from a high-risk country. Heliyon . 2021/06/01/ 2021;7(6):e07385. doi:https://doi.org/10.1016/j.heliyon.2021.e07385 Fottrell E, Ahmed N, Morrison J, et al. Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial. The Lancet Diabetes & Endocrinology . 2019/03/01/ 2019;7(3):200-212. doi:https://doi.org/10.1016/S2213-8587(19)30001-4 Tables Table 1: Status of the D:Clare Stepped-Wedge Trial at the point of COVID-19 field activity suspension on 20 th March 2020 Milestone Status Administration Ethical approvals Approvals received from University College London (07/11/22) and Diabetic Association of Bangladesh (03/12/19) Trial registration Registered on 31/10/19 Community entry, consent and public randomisation. Meeting held 16/01/20 Evaluation Community census for development of sampling frame Data collection completed 04/02/20 Recruitment and training of survey field staff Training completed 10/02/20 Baseline cross-sectional survey (target sample=1320 across the 12 study clusters) Interrupted. 72% of the survey completed, with data gathered across all clusters, by 20/03/20. Follow-up data cleaning was conducted by phone. Intervention Recruitment and training of PLA community group intervention facilitators and supervisors Completed Formation of PLA community groups in 6 clusters Completed Table 2: Summary of key changes from original stepped-wedge design to parallel arm wait-list trial. Trial component Original stepped-wedge design Parallel arm waitlist design Intervention implementation Delivery to all clusters in two steps. 50% of clusters to receive the intervention from month 1 and the remaining 50% to receive the intervention from month 12. Delivered to all clusters in two steps. 50% of clusters (i.e. intervention arm) to receive the intervention from month 1 and the remaining 50% (i.e. control arm) to receive the intervention after the trial end at approx. month 30. Up to 216 PLA community groups meeting on a monthly basis to progress through a schedule of 18 meetings over approx. 18 months. Up to 216 PLA community groups meeting twice per month to progress through a schedule of a minimum of 13 meetings over a period of approx. 30 months. Total duration of implementation across all 12 clusters to be approx. 24 months. Total duration of implementation across all 12 clusters to be approx. 30 months (including periods of ‘lockdown’ where was paused. Timing of survey data collection At baseline (month 1), month 12, and month 24. At baseline (month 1) and post intervention implementation in intervention clusters (approx. month 30). Cluster exposure over time Depends on timing - all clusters contribute data to both control and intervention exposure. No change over time, i.e. intervention arm contributes to intervention exposure only, control arm contributes to control only. Total duration of project 36 months 54 months Box Box 1: Summary of registered trial protocol revisions in the D:Clare ISRCTN record 17/11/2021 1. Publication reference added. 2. The individual participant data (IPD) sharing statement has been updated. 17/12/2020 1. Ethics approval details added. 2. The study design was changed from 'Stepped-wedge cluster randomized trial' to a 'Cluster randomized controlled trial', with scale-up to control clusters after trial completion (‘wait-list’). 3. The interventions and primary and secondary outcome measures were updated. 4. The target number of participants measured across the baseline and endline surveys was changed from '12 clusters; 440 individuals per cluster' to '12 clusters; 211 individuals per cluster'. 5. The recruitment start date was changed from 07/12/2019 to 04/01/2020. 06/03/2020 1. Ethics approval and secondary outcome measures updated. Cite Share Download PDF Status: Published Journal Publication published 23 Mar, 2023 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 18 Oct, 2022 Reviewers invited by journal 31 Aug, 2022 Editor assigned by journal 24 Aug, 2022 First submitted to journal 23 Aug, 2022 Editorial decision: Minor revision 29 Jul, 2022 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-1665799","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":133110159,"identity":"76b9e435-878b-440e-8419-7487fe021c7b","order_by":0,"name":"Carina King","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAzklEQVRIiWNgGAWjYJCCA0BswMbAwPiwwYBELcyGRGsBAZBaNskGYpTyt599eLighsGYT7r9WuWMAgZ7fkJaJM6kGxyecYzBjE3mTNnNDQYMiTMJWWXAkMZwmIeNwYZNIift5gMDhgSDA4S08D8DavkH0VII1GJvT1CLBNAW3jagwyTSjzECHca4gaBfbgBt4e2TMAbawiw5w0AicQYhW/j705g/83yzMZw/I/3hx54/Nvb8DYSsgVoGxDwGUAbxgP0BScpHwSgYBaNg5AAAXfA4Vh0/EvIAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-6885-6716","institution":"Karolinska Institutet","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Carina","middleName":"","lastName":"King","suffix":""},{"id":133110160,"identity":"7d03dfef-3b1e-4129-81df-b2f0499136b2","order_by":1,"name":"Malini Pires","email":"","orcid":"","institution":"University College London","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Malini","middleName":"","lastName":"Pires","suffix":""},{"id":133110161,"identity":"85a620ce-181a-4db5-ab4a-be65f65e74a5","order_by":2,"name":"Naveed Ahmed","email":"","orcid":"","institution":"Diabetic Association of Bangladesh","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Naveed","middleName":"","lastName":"Ahmed","suffix":""},{"id":133110162,"identity":"95519763-de43-433c-8790-5cf5e0807433","order_by":3,"name":"Kohenour Akter","email":"","orcid":"","institution":"Diabetic Association of Bangladesh","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Kohenour","middleName":"","lastName":"Akter","suffix":""},{"id":133110163,"identity":"d7b1bd27-a361-47d6-a43c-779d814438cc","order_by":4,"name":"Abdul Kuddus","email":"","orcid":"","institution":"Diabetic Association of Bangladesh","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Abdul","middleName":"","lastName":"Kuddus","suffix":""},{"id":133110164,"identity":"d0aba53f-7f61-4c0d-825b-ba888b92bd92","order_by":5,"name":"Andrew Copas","email":"","orcid":"","institution":"University College London","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Andrew","middleName":"","lastName":"Copas","suffix":""},{"id":133110165,"identity":"b218f980-6c73-4422-a52e-aa677d693f10","order_by":6,"name":"Hassan Haghparast-Bidgoli","email":"","orcid":"","institution":"University College London","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Hassan","middleName":"","lastName":"Haghparast-Bidgoli","suffix":""},{"id":133110166,"identity":"75fd02c8-e5ef-4912-8673-6bbd43a8f5e2","order_by":7,"name":"Joanna Morrison","email":"","orcid":"","institution":"University College London","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Joanna","middleName":"","lastName":"Morrison","suffix":""},{"id":133110167,"identity":"7625ee74-1a66-49a4-b4bc-5449b50cad39","order_by":8,"name":"Tasmin Nahar","email":"","orcid":"","institution":"Diabetic Association of Bangladesh","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Tasmin","middleName":"","lastName":"Nahar","suffix":""},{"id":133110168,"identity":"2498647a-1d6d-4095-9287-10e7bc494ebe","order_by":9,"name":"Sanjit Kumer Shaha","email":"","orcid":"","institution":"Diabetic Association of Bangladesh","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Sanjit","middleName":"Kumer","lastName":"Shaha","suffix":""},{"id":133110169,"identity":"87d56197-ded7-4dba-9d3d-8d6ad081cb68","order_by":10,"name":"A K Azad Khan","email":"","orcid":"","institution":"Diabetic Association of Bangladesh","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"A","middleName":"K Azad","lastName":"Khan","suffix":""},{"id":133110170,"identity":"11d7a009-96ee-4a81-86ad-6560d492d6b6","order_by":11,"name":"Kishwar Azad","email":"","orcid":"","institution":"Diabetic Association of Bangladesh","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Kishwar","middleName":"","lastName":"Azad","suffix":""},{"id":133110171,"identity":"245449d4-a631-4ec6-ac6e-912aa63f5dc6","order_by":12,"name":"Edward Fottrell","email":"","orcid":"https://orcid.org/0000-0003-0518-7161","institution":"University College London","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Edward","middleName":"","lastName":"Fottrell","suffix":""}],"badges":[],"createdAt":"2022-05-17 13:59:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-1665799/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-1665799/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-023-07243-x","type":"published","date":"2023-03-23T20:07:53+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":25990640,"identity":"64832e74-ceb3-483a-be1b-b7f93dc45dec","added_by":"auto","created_at":"2022-09-02 15:41:59","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":59740,"visible":true,"origin":"","legend":"\u003cp\u003ePlanned D:Clare project timeline and COVID-19 interruptions\u003c/p\u003e","description":"","filename":"Figure1TrialDesign.png","url":"https://assets-eu.researchsquare.com/files/rs-1665799/v1/eda5e5e124a0e347015203c3.png"},{"id":25990641,"identity":"ec5108a2-858b-4604-b8ec-f267faf3213c","added_by":"auto","created_at":"2022-09-02 15:41:59","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":91842,"visible":true,"origin":"","legend":"\u003cp\u003eD:Clare Trial stop, pause and start rules for COVID-19 adaptation\u003c/p\u003e","description":"","filename":"Figure2StopStartRules.png","url":"https://assets-eu.researchsquare.com/files/rs-1665799/v1/c94e0b5a95fd5e2c639eb11f.png"},{"id":44723554,"identity":"6825f5f2-155a-425b-846a-67e2993396fa","added_by":"auto","created_at":"2023-10-16 20:16:40","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":576128,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1665799/v1/edcbc4a2-265c-4713-917b-19258484e040.pdf"}],"financialInterests":"","formattedTitle":"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","fulltext":[{"header":"Full Text","content":"\u003cp\u003eThe 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).\u003csup\u003e1\u003c/sup\u003e 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.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBangladesh reported its first confirmed cases of SARS-CoV-2 on the 8\u003csup\u003eth\u003c/sup\u003e March. Due to concerns about infection risk to both staff and communities, we made a decision to suspend all field-based project activities on the 20\u003csup\u003eth\u003c/sup\u003e March 2020 (\u003cstrong\u003eFigure 1\u003c/strong\u003e). Early in the pandemic, evidence emerged that uncontrolled hyperglycaemia and type 2 diabetes (T2DM) were risks for severe COVID-19 infections and mortality, alongside older age, obesity and heart disease.\u003csup\u003e2-4\u003c/sup\u003e Given the focus and nature of our PLA intervention, we were therefore particularly conscious that continuing the trial may have increased risks amongst vulnerable populations with non-communicable diseases. The status of the trial at the point of suspension is summarised in \u003cstrong\u003eTable 1\u003c/strong\u003e. Bangladesh subsequently entered into a nationwide government declared lockdown from the 23\u003csup\u003erd\u003c/sup\u003e March to 30\u003csup\u003eth\u003c/sup\u003e May 2020, and restrictions on mass gatherings continued until 1\u003csup\u003est\u003c/sup\u003e September 2020.\u003csup\u003e5\u003c/sup\u003e The second serious COVID-19 wave began in March 2021, and lockdowns were again implemented between 5\u003csup\u003eth\u003c/sup\u003e April - 21\u003csup\u003est\u003c/sup\u003e April 2021 and 1\u003csup\u003est\u003c/sup\u003e July \u0026ndash; 11st August 2021.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis short article summarises the changes to our original trial design whilst detailing the considerations and rationale for these changes, which may be of relevance to other randomised controlled trials underway in dynamic contexts.\u003c/p\u003e"},{"header":"Change In Trial Design","content":"\u003cp\u003eAs the result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we decided to change from a stepped-wedge (SW-RCT) to a wait-list parallel arm cluster RCT (cRCT) with baseline data. Conceptually, our wait-list design is a parallel arm cRCT but with commitment to implement the intervention to control clusters at the end of the trial evaluation. As detailed in \u003cstrong\u003eTable 2\u003c/strong\u003e, this differs from our stepped-wedge trial design in terms of the timing of roll-out of the intervention across all clusters, timing of cross-sectional data collection for evaluation, and in terms of how clusters are exposed over time, i.e. the allocated exposure (intervention or control) does not change during the trial evaluation. 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 (\u003cstrong\u003eFigure 1\u003c/strong\u003e).\u003csup\u003e1\u003c/sup\u003e 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 efficient and appropriate to meet project goals, and we presented alternative options to our Trial Steering Committee for consideration. We had four key reasons for eventually agreeing to change designs. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eEquipoise\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe D:Clare PLA intervention was shown to be effective in reducing both the 2-year cumulative incidence and prevalence of T2DM in a rural Bangladesh population during the D-Magic trial.\u003csup\u003e6\u003c/sup\u003e This was part of the justification for us using a SW-RCT originally, as evidence of population benefit existed, and our aim was to determine effectiveness at-scale in a similar but new population. However, with the considerable change in context and potential need to adapt the intervention components and delivery, the lack of equipoise around the PLA intervention we had previously argued was less clear. Specifically, our intervention encourages groups to meet, encourages participation from those with T2DM and NCDs and encourages collective action. In a context where COVID-19 preventive measures focused on restricting inter-household interactions, we hypothesised that PLA\u0026rsquo;s mechanism of action may be affected.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFurther, if COVID-19 cases were not being diagnosed in this community setting, then group meetings had the potential to cause harm. However, by the end of 2020 there was evidence that outdoor environments posed a lower risk of transmission than indoor, crowded spaces, especially if this can be combined with the use of face masks, hand hygiene and physical distancing. Given the potential for our intervention to improve T2DM management (a key risk for poor COVID-19 outcomes), the ability to deliver in a way that would reduce transmission, and inclusion of new stop/start rules (\u003cstrong\u003eFigure 2\u003c/strong\u003e), we felt this risk could be sufficiently mitigated. We therefore decided we met the criteria for equipoise around the intervention needed to do a parallel group cluster RCT. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTemporal bias in exposure and outcomes\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eWe also hypothesised that post-COVID-19 health literacy, care-seeking, dietary and physical activity behaviours, and the epidemiology of diabetes could be vastly different after lockdown restrictions were lifted \u0026ndash; and therefore from our baseline survey. This in itself should not invalidate the SW-RCT design, but could make interpretation and communication of the intervention impact on primary and secondary outcomes more complicated. The timing of intervention delivery relative to lockdown and social distancing measures was also likely to have an important influence on the uptake, delivery and effectiveness of the intervention. This may result in variable intervention effects between the two steps of SW implementation, which could be assessed through process evaluation, but again would complicate interpretation.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eLoss of power\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOur power calculation was based on achieving at least an 80% response in the first cross-sectional survey. However, we only achieved 72% recruitment at the time of interruption, and saw variation in rates between clusters (49% - 89%). In order to then ensure the SW-RCT was sufficiently powered, we would have had to increase the sample size of all the subsequent surveys. Switching to a parallel arm trial which uses both a new baseline and endline data (assuming an autocorrelation of 0.4), we could achieve 78% power for a 30% reduction in the primary outcome and considered this a feasible alternative. The change to the number and timing of surveys and inclusion of baseline data in outcome evaluation are notable changes to our original protocol (Table 2).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTime and funding\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFinally, there was a very practical issue that we no longer had enough time to complete the SW-RCT design within the overall 36-month funded project period, using our 12-month staggered two-step design. By switching to a parallel cRCT we could complete the effectiveness evaluation within the funded project timeline, albeit answering a slightly different evaluation question. We then planned to source project extensions and resources to scale-up the intervention into the control clusters as was promised to communities, but without incurring on-going concurrent process, economic and impact evaluation costs.\u0026nbsp;\u003c/p\u003e"},{"header":"Protocol Updates","content":"\u003cp\u003eWe made changes to three key areas of the trial protocol: study design, intervention and sample size; no amendments were made to the trial procedures for population eligibility, sampling, randomisation, blinding, data collection, or analysis of the primary or secondary outcomes. A list of registered trial protocol amendments in our ISRCTN record are summarised in \u003cstrong\u003eBox 1\u003c/strong\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe also set-out COVID-19 standard operating procedures, with new stop-start rules (\u003cstrong\u003eFigure 2\u003c/strong\u003e), a COVID-19 safety protocol for staff and study participants, and consulted with a Data Monitoring and Safety Board on these infection prevention measures. For the intervention, we made the following modifications to incorporate COVID-19 measures: holding two meetings per village per month to allow for smaller groups but with the same coverage; inclusion of COVID-19 health information; re-organised meeting content to be delivered over a minimum of 13 instead of the planned 18 meetings (Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCurrent Trial Status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs of the 22/04/2022: We completed a new baseline survey on the 25/02/2021, with a response rate of 1,392 from 1,584 (87.9%) sampled participants, which forms the parallel arm cRCT baseline data. A total of 213 PLA groups have been formed in 6 of the 12 study clusters, and have completed 11 of a minimum 13 planned meetings. The endline survey will be completed between August and October 2022.\u003c/p\u003e\n\u003cp\u003eProtocol version 3.0 (16/06/2021)\u003c/p\u003e\n"},{"header":"Abbreviations","content":"\u003cp\u003eD:Clare: \u0026nbsp;(Diabetes: Community-Led Awareness, Response and Evaluation)\u003c/p\u003e\n\u003cp\u003eNCD: non-communicable disease\u003c/p\u003e\n\u003cp\u003ePLA: participatory learning and action\u003c/p\u003e\n\u003cp\u003eRCT: randomised controlled trial\u003c/p\u003e\n\u003cp\u003eSW-RCT: stepped-wedge randomised controlled trial\u003c/p\u003e\n\u003cp\u003eT2DM: type-2 diabetes mellitus\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cem\u003eEthics approval and consent to participate:\u0026nbsp;\u003c/em\u003eWritten informed consent will be obtained from all survey and interview participants by study staff. Community consent was sought from community leaders prior to randomisation and intervention implementation. Ethical approvals were provided by\u0026nbsp;University College London Research Ethics Committee (ref: 4199/007) and the Ethical Review Committee of the Diabetic Association of Bangladesh (ref: BADAS-ERC/E/19/00276).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConsent for publication:\u0026nbsp;\u003c/em\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and materials:\u0026nbsp;\u003c/em\u003eData required to support the protocol can be supplied on request.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompeting interests:\u0026nbsp;\u003c/em\u003eThe authors declare no competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding:\u0026nbsp;\u003c/em\u003eThe trial is funded by the UK Medical Research Council (ref:\u0026nbsp;MR/T023562/1)\u0026nbsp;under the Global Alliance for Chronic Diseases (GACD) Diabetes Programme.\u0026nbsp;Peer review of the grant application provided input into the study proposal. Beyond that, the funder has no role in the design of the study, data collection, analysis and interpretation, or the write-up of the findings.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthors\u0026apos; contributions:\u0026nbsp;\u003c/em\u003eEF is the principal investigator. He led the design of the study, wrote the first draft of the study protocol, and will participate in the analysis and interpretation of data. AK is project manager of the trial, overseeing all activities. CK is a senior researcher on the project, supporting the design, analysis and interpretation of data, and overseeing the data collection and management system. MP is research assistant on the study, contributing to design, analysis and interpretation of data. JM is a senior researcher on the project, leading design, analysis and interpretation of the process evaluation. HHB is senior researcher on the project, leading the economic evaluation and equity components. AC is the trial statistician, and contributed to the design of the study and will participate in the analysis and interpretation of data. NA contributed to protocol development, fieldworker training, and development of interventions. SKS coordinates survey data collection and processes and will participate in the analysis and interpretation of data. TN contributed to the design of interventions and is responsible for intervention implementation. KAk contributed to the design of the process evaluation. AKAK provides technical oversight. KAz is project director, contributed to the design of the study, leads the implementation of the trial and will participate in interpretation of data.\u0026nbsp;All authors read and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAcknowledgements:\u0026nbsp;\u003c/em\u003eWe thank the members of our trial steering committee: Dr David Beran (Chair), Prof Graham Hitman, Prof Sarah Hawkes, Prof Anthony Costello, Prof Edward Gregg, Dr Jennifer Thompson, Prof Audrey Prost, Prof Justine Davies. We would also like to acknowledge the communities and community leaders for their engagement with the project.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eKing C, Pires M, Ahmed N, et al. 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. \u003cem\u003eTrials\u003c/em\u003e. 2021/03/29 2021;22(1):235. doi:10.1186/s13063-021-05167-y\u003c/li\u003e\n\u003cli\u003eZhu L, She Z-G, Cheng X, et al. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. \u003cem\u003eCell Metabolism\u003c/em\u003e. 2020/06/02/ 2020;31(6):1068-1077.e3. doi:https://doi.org/10.1016/j.cmet.2020.04.021\u003c/li\u003e\n\u003cli\u003eHo FK, Petermann-Rocha F, Gray SR, et al. Is older age associated with COVID-19 mortality in the absence of other risk factors? General population cohort study of 470,034 participants. \u003cem\u003ePLOS ONE\u003c/em\u003e. 2020;15(11):e0241824. doi:10.1371/journal.pone.0241824\u003c/li\u003e\n\u003cli\u003eMesas AE, Cavero-Redondo I, \u0026Aacute;lvarez-Bueno C, et al. Predictors of in-hospital COVID-19 mortality: A comprehensive systematic review and meta-analysis exploring differences by age, sex and health conditions. \u003cem\u003ePLOS ONE\u003c/em\u003e. 2020;15(11):e0241742. doi:10.1371/journal.pone.0241742\u003c/li\u003e\n\u003cli\u003eSiam MHB, Hasan MM, Tashrif SM, Rahaman Khan MH, Raheem E, Hossain MS. Insights into the first seven-months of COVID-19 pandemic in Bangladesh: lessons learned from a high-risk country. \u003cem\u003eHeliyon\u003c/em\u003e. 2021/06/01/ 2021;7(6):e07385. doi:https://doi.org/10.1016/j.heliyon.2021.e07385\u003c/li\u003e\n\u003cli\u003eFottrell E, Ahmed N, Morrison J, et al. Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial. \u003cem\u003eThe Lancet Diabetes \u0026amp; Endocrinology\u003c/em\u003e. 2019/03/01/ 2019;7(3):200-212. doi:https://doi.org/10.1016/S2213-8587(19)30001-4\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1:\u0026nbsp;Status of the D:Clare Stepped-Wedge Trial at the point of COVID-19 field activity suspension on 20\u003csup\u003eth\u003c/sup\u003e March 2020\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"7.820299500831947%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"56.572379367720465%\"\u003e\n \u003cp\u003eMilestone\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"35.607321131447584%\"\u003e\n \u003cp\u003eStatus\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" width=\"7.820299500831947%\"\u003e\n \u003cp\u003eAdministration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"56.572379367720465%\"\u003e\n \u003cp\u003eEthical approvals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"35.607321131447584%\"\u003e\n \u003cp\u003eApprovals received from University College London (07/11/22) and Diabetic Association of Bangladesh (03/12/19)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"61.371841155234655%\"\u003e\n \u003cp\u003eTrial registration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"38.628158844765345%\"\u003e\n \u003cp\u003eRegistered on 31/10/19\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"61.371841155234655%\"\u003e\n \u003cp\u003eCommunity entry, consent and public randomisation.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"38.628158844765345%\"\u003e\n \u003cp\u003eMeeting held 16/01/20\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" width=\"7.820299500831947%\"\u003e\n \u003cp\u003eEvaluation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"56.572379367720465%\"\u003e\n \u003cp\u003eCommunity census for development of sampling frame\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"35.607321131447584%\"\u003e\n \u003cp\u003eData collection completed 04/02/20\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"61.371841155234655%\"\u003e\n \u003cp\u003eRecruitment and training of survey field staff\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"38.628158844765345%\"\u003e\n \u003cp\u003eTraining completed 10/02/20\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"61.371841155234655%\"\u003e\n \u003cp\u003eBaseline cross-sectional survey (target sample=1320 across the 12 study clusters)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"38.628158844765345%\"\u003e\n \u003cp\u003eInterrupted. 72% of the survey completed, with data gathered across all clusters, by 20/03/20. Follow-up data cleaning was conducted by phone.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" width=\"7.820299500831947%\"\u003e\n \u003cp\u003eIntervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"56.572379367720465%\"\u003e\n \u003cp\u003eRecruitment and training of PLA community group intervention facilitators and supervisors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"35.607321131447584%\"\u003e\n \u003cp\u003eCompleted\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"61.371841155234655%\"\u003e\n \u003cp\u003eFormation of PLA community groups in 6 clusters\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"38.628158844765345%\"\u003e\n \u003cp\u003eCompleted\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 2: Summary of key changes from original stepped-wedge design to parallel arm wait-list trial.\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"19.767441860465116%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTrial component\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"37.37541528239203%\"\u003e\n \u003cp\u003e\u003cstrong\u003eOriginal stepped-wedge design\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"42.857142857142854%\"\u003e\n \u003cp\u003e\u003cstrong\u003eParallel arm waitlist design\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"3\" valign=\"top\" width=\"19.767441860465116%\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention implementation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"37.37541528239203%\"\u003e\n \u003cp\u003eDelivery to all clusters in two steps. 50% of clusters to receive the intervention from month 1 and the remaining 50% to receive the intervention from month 12.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"42.857142857142854%\"\u003e\n \u003cp\u003eDelivered to all clusters in two steps. 50% of clusters (i.e. intervention arm) to receive the intervention from month 1 and the remaining 50% (i.e. control arm) to receive the intervention after the trial end at approx. month 30.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"46.58385093167702%\"\u003e\n \u003cp\u003eUp to 216 PLA community groups meeting on a monthly basis to progress through a schedule of 18 meetings over approx. 18 months.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"53.41614906832298%\"\u003e\n \u003cp\u003eUp to 216 PLA community groups meeting twice per month to progress through a schedule of a minimum of 13 meetings over a period of approx. 30 months.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"46.58385093167702%\"\u003e\n \u003cp\u003eTotal duration of implementation across all 12 clusters to be approx. 24 months.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"53.41614906832298%\"\u003e\n \u003cp\u003eTotal duration of implementation across all 12 clusters to be approx. 30 months (including periods of \u0026lsquo;lockdown\u0026rsquo; where was paused.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"19.767441860465116%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTiming of survey data collection\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"37.37541528239203%\"\u003e\n \u003cp\u003eAt baseline (month 1), month 12, and month 24.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"42.857142857142854%\"\u003e\n \u003cp\u003eAt baseline (month 1) and post intervention implementation in intervention clusters (approx. month 30).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"19.767441860465116%\"\u003e\n \u003cp\u003e\u003cstrong\u003eCluster exposure over time\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"37.37541528239203%\"\u003e\n \u003cp\u003eDepends on timing - all clusters contribute data to both control and intervention exposure.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"42.857142857142854%\"\u003e\n \u003cp\u003eNo change over time, i.e. intervention arm contributes to intervention exposure only, control arm contributes to control only.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"19.767441860465116%\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal duration of project\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"37.37541528239203%\"\u003e\n \u003cp\u003e36 months\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"42.857142857142854%\"\u003e\n \u003cp\u003e54 months\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Box ","content":"\u003cp\u003eBox 1: Summary of registered trial protocol revisions in the D:Clare ISRCTN record\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.640599001663894%\"\u003e\n \u003cp\u003e17/11/2021\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"84.35940099833611%\"\u003e\n \u003cp\u003e1. Publication reference added.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2. The individual participant data (IPD) sharing statement has been updated.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.640599001663894%\"\u003e\n \u003cp\u003e17/12/2020\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"84.35940099833611%\"\u003e\n \u003cp\u003e1. Ethics approval details added.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2. The study design was changed from \u0026apos;Stepped-wedge cluster randomized trial\u0026apos; to a \u0026apos;Cluster randomized controlled trial\u0026apos;, with scale-up to control clusters after trial completion (\u0026lsquo;wait-list\u0026rsquo;).\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3. The interventions and primary and secondary outcome measures were updated.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4. The target number of participants measured across the baseline and endline surveys was changed from \u0026apos;12 clusters; 440 individuals per cluster\u0026apos; to \u0026apos;12 clusters; 211 individuals per cluster\u0026apos;.\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5. The recruitment start date was changed from 07/12/2019 to 04/01/2020.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"15.640599001663894%\"\u003e\n \u003cp\u003e06/03/2020\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"84.35940099833611%\"\u003e\n \u003cp\u003e1. Ethics approval and secondary outcome measures updated.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Diabetes, non-communicable diseases, Bangladesh, participatory learning and action, stepped-wedge trial, cluster RCT","lastPublishedDoi":"10.21203/rs.3.rs-1665799/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1665799/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThe “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. \u003c/p\u003e\u003cp\u003eThe trial was originally designed as a stepped-wedge cluster randomised controlled trial, from March 2020 – September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at project 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 20\u003csup\u003eth\u003c/sup\u003e 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.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\u003cp\u003eTrial registration:\u003cem\u003e \u003c/em\u003eISRCTN42219712 (https://doi.org/10.1186/ISRCTN42219712). Registration date: 31/10/2019.\u003c/p\u003e","manuscriptTitle":"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","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-09-02 15:41:58","doi":"10.21203/rs.3.rs-1665799/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2022-10-18T13:20:38+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2022-08-31T13:18:21+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2022-08-24T06:02:44+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2022-08-23T05:38:28+00:00","index":"","fulltext":""},{"type":"decision","content":"Minor revision","date":"2022-07-29T11:24:15+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"beaa89b0-ca35-4d10-9753-a15d7e6b9d5c","owner":[],"postedDate":"September 2nd, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2023-10-16T20:14:59+00:00","versionOfRecord":{"articleIdentity":"rs-1665799","link":"https://doi.org/10.1186/s13063-023-07243-x","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2023-03-23 20:07:53","publishedOnDateReadable":"March 23rd, 2023"},"versionCreatedAt":"2022-09-02 15:41:58","video":"","vorDoi":"10.1186/s13063-023-07243-x","vorDoiUrl":"https://doi.org/10.1186/s13063-023-07243-x","workflowStages":[]},"version":"v1","identity":"rs-1665799","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1665799","identity":"rs-1665799","version":["v1"]},"buildId":"FbvkV6FR0MCFSLy54lSbu","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}