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Table 3 Summary of registered trial protocol revisions in the D:Clare ISRCTN record

From: 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

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.

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ISSN: 1745-6215