All partners will participate in dissemination of the research, to maximise the impact of our findings in Europe, South Asia and internationally. Dissemination and exploitation will include multiple communication strategies. We will submit technical reports and organise presentations on the research to i. international bodies responsible for diabetes, non-communicable disease and global health including the IDF, WHO, World Bank, UN, GACD, ii. the local and national Health Departments of countries on the Indian subcontinent, UK, Netherlands and other countries where South Asians have settled in large numbers and iii. other relevant organisations eg Wellcome Trust, Public Health foundation of India, Gates Foundation and the Fred Hollows Foundation.
The primary aim of the health economic analysis is to determine the cost-effectiveness of family based lifestyle modification vs usual care for prevention of T2D amongst i. South Asians on the Indian subcontinent and ii. South Asians in Europe.
Our study is well powered to detect the ~42% reduction in risk predicted from our studies of family-based intervention in the UK, and the effect sizes for reduction of risk of T2D observed in published studies of lifestyle modification vs usual care for prevention of T2D (30-60%). The analysis committee will be responsible for data monitoring during the study, for the primary and secondary analyses of the study endpoints, and for assisting the consortium prepare technical reports for dissemination of the research findings.
We will determine the incidence of T2D incidence in the control group at 2 years to assess whether T2D incidence is lower than anticipated (eg health cohort effect).
With a sample size of 3,600 we therefore expect to identify up ~734 cases of new onset T2D over three years under the null hypothesis. Assuming a 10% dropout rate , with a 1:1 allocation ratio, a total of 120 clusters each of size 30, our study has 80% power to identify at P<0.017, a reduction in the incidence of T2D for family-based lifestyle modification vs usual care.
Establish a project web-site to promote the project, and allow simple, and secure, transfer of data, results and reports between participants.
The project website will provide details of the rationale, design, methods and results of the trial in an open access format. Lay language will be used where possible to ensure that the general public will understand and be engaged with the potential positive impact of lifestyle intervention on T2D prevention. The website will also serve as a platform for engaging scientific colleagues, clinicians and healthy policy makers.
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Author(s): Mirthe Muilwijk1*, Marie Loh2,3*, Sara Mahmood4, Saranya Palaniswamy3,5, Samreen Siddiqui6, Wnurinham Silva3, Gary S. Frost7, Heather M. Gage8, Marjo-Riitta Jarvelin3,5,9,10, Ravindra P. Rannan-Eliya11, Sajjad Ahmed12, Sujeet Jha6, Anuradhani Kasturiratne13, Prasad Katulanda14, Khadija I. Khawaja4, Jaspal S. Kooner15,16, Ananda R. Wickremasinghe13, Irene G.M. van Valkengoed1**, John C. Chambers2,3
Published in: Trials, 2020