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There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Hypothesis<\/jats:title>\n                    <jats:p>Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Entry criteria<\/jats:title>\n                    <jats:p>\n                      South Asian, men or women, age 40\u201370\u2009years with (i) central obesity (waist circumference \u2265 100\u2009cm in India and Pakistan; \u226590\u2009cm in Sri Lanka) and\/or (ii) prediabetes (HbA1c 6.0\u20136.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index &lt;\u200922\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Endpoints<\/jats:title>\n                    <jats:p>The primary endpoint is new-onset T2D at 3\u2009years, defined as (i) HbA1c \u2265 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3\u2009years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12\u2009months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (\n                      <jats:italic>SD<\/jats:italic>\n                      8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IRB approval<\/jats:title>\n                    <jats:p>16\/WM\/0171<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      EudraCT\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.hra.nhs.uk\/planning-and-improving-research\/application-summaries\/research-summaries\/ihealth-t2d\/\">2016-001350-18<\/jats:ext-link>\n                      . Registered on 14 April 2016.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02949739\">NCT02949739<\/jats:ext-link>\n                      . Registered on 31 October 2016, First posted on 31\/10\/2016.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05803-7","type":"journal-article","created":{"date-parts":[[2021,12,18]],"date-time":"2021-12-18T04:02:39Z","timestamp":1639800159000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial"],"prefix":"10.1186","volume":"22","author":[{"given":"Anuradhani","family":"Kasturiratne","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khadija I.","family":"Khawaja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sajjad","family":"Ahmad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samreen","family":"Siddiqui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khurram","family":"Shahzad","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lathika K.","family":"Athauda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ranil","family":"Jayawardena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Mahmood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3686-5116","authenticated-orcid":false,"given":"Mirthe","family":"Muilwijk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tayyaba","family":"Batool","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saira","family":"Burney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Glover","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saranya","family":"Palaniswamy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vodathi","family":"Bamunuarachchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manju","family":"Panda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suren","family":"Madawanarachchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baldeesh","family":"Rai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iqra","family":"Sattar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wnurinham","family":"Silva","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swati","family":"Waghdhare","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marjo-Riitta","family":"Jarvelin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravindra P.","family":"Rannan-Eliya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather M.","family":"Gage","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene G. 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Information sheets and consent forms were made available in the major South Asian languages. Multilingual translators were available as required. Each participant provided informed consent, which was obtained by the study research assistants and research nurses, under the supervision of the local principal investigator. People unwilling or unable to provide consent were excluded from the study.<i>India<\/i>\u2022 Max Healthcare Institutional Ethic Committee (ref: CT\/MSSH\/SKT-2\/ENDO\/IEC\/14-40, date 22\/04\/16)\u2022 Indian Council for Medical Research (ICMR, ref: 55\/7\/Indo-Foreign-Diab\/2014-NCD-II, date 08\/02\/2016)<i>Pakistan<\/i>\u2022 Punjab Institute of Cardiology Ethical Committee (ref: rtpgme-research-047, date 09\/04\/16)\u2022 Services Institute of Medical Sciences Institutional Review Board (ref: IRB\/2016\/222\/SIMS, date 12\/03\/16)<i>Sri Lanka<\/i>\u2022 University of Colombo Ethics Review Committee (ref: EC-16-063, date 23\/05\/16)\u2022 University of Kelaniya Ethics Review Committee (ref: P\/62\/05\/2016, date 11\/05\/16)<i>UK<\/i>\u2022 West Midlands - Solihull Research Ethics Committee (ref: 16\/WM\/0171, date 14\/04\/2016)","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"928"}}