13063_2021_5803_MOESM1_ESM.zip (10.09 MB)
Additional file 1 of The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial
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posted on 2021-12-19, 04:20 authored by Anuradhani Kasturiratne, Khadija I. Khawaja, Sajjad Ahmad, Samreen Siddiqui, Khurram Shahzad, Lathika K. Athauda, Ranil Jayawardena, Sara Mahmood, Mirthe Muilwijk, Tayyaba Batool, Saira Burney, Matthew Glover, Saranya Palaniswamy, Vodathi Bamunuarachchi, Manju Panda, Suren Madawanarachchi, Baldeesh Rai, Iqra Sattar, Wnurinham Silva, Swati Waghdhare, Marjo-Riitta Jarvelin, Ravindra P. Rannan-Eliya, Heather M. Gage, Irene G. M. van Valkengoed, Jonathan Valabhji, Gary S. Frost, Marie Loh, Ananda R. Wickremasinghe, Jaspal S. Kooner, Prasad Katulanda, Sujeet Jha, John C. ChambersAdditional file 1: S1. CHW Handbook. Training manual summarising the content and delivery of the lifestyle intervention. Translated versions available through study website. S2. CHW Workbook. Case report form / intervention delivery workbook for the lifestyle intervention. Translated versions available through study website. S3. Participant Handbook for Lifestyle intervention. Written materials provided to the participant to support the CHW delivered lifestyle intervention. Translated versions available through study website. S4. Participant Handbook for Usual care. Translated versions available through study website. Supplementary Table 1: The a-priori power calculations under alternate assumptions with a sample size of 3,600 participants.
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target recruitment 3600irb approval 16body mass index13 telephone sessionsscalable across settingsper annum ).m2 ); pregnantlifestyle modification advicecommunity health workerscommunity health worker14 april 2016usual care comprised0 – 6usual care sitesknown type 160 sites ).4 group sessionshba1c ≥ 6≥ 90 cmtype 2 diabetesincreased physical activity31 october 2016intervention lifestyle interventionusual care60 sitesphysical activitylifestyle interventionone sessionshba1c 6triglycerides );resource settingslifestyle measuresinclusive ).2 diabetesraised hba1cphysical measurest2d ).waist circumferenceuse approachesurgent needunstable residencethus informtake partsri lankasouth asianssouth asiasmoking statussingle 30serious illnessscreened 33primary endpointphysician diagnosisparticipants achievingobserved incidencemin sessionincreased riskimproved diethypothesis comparedhdl cholesterolgov nct02949739first postedfasting glucoseexclusion criteriaend 2019dietary intakedevelop approachesdecember 2020cm reductionclinical characteristicscentral obesityblood pressurebiochemical measuresalcohol intakeaged 52advance understanding930 people3682 agreed22 kg212 people1 allocation
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