Please use this identifier to cite or link to this item: https://hdl.handle.net/10356/163013
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
Authors: Kasturiratne, Anuradhani
Khawaja, Khadija I.
Ahmad, Sajjad
Siddiqui, Samreen
Shahzad, Khurram
Athauda, Lathika K.
Jayawardena, Ranil
Mahmood, Sara
Muilwijk, Mirthe
Batool, Tayyaba
Burney, Saira
Glover, Matthew
Palaniswamy, Saranya
Bamunuarachchi, Vodathi
Panda, Manju
Madawanarachchi, Suren
Rai, Baldeesh
Sattar, Iqra
Silva, Wnurinham
Waghdhare, Swati
Jarvelin, Marjo-Riitta
Rannan-Eliya, Ravindra P.
Gage, Heather M.
van Valkengoed, Irene G. M.
Valabhji, Jonathan
Frost, Gary S.
Loh, Marie
Wickremasinghe, Ananda R.
Kooner, Jaspal S.
Katulanda, Prasad
Jha, Sujeet
Chambers, John C.
Keywords: Science::Medicine
Issue Date: 2021
Source: Kasturiratne, A., Khawaja, K. I., Ahmad, S., Siddiqui, S., Shahzad, K., Athauda, L. K., Jayawardena, R., Mahmood, S., Muilwijk, M., Batool, T., Burney, S., Glover, M., Palaniswamy, S., Bamunuarachchi, V., Panda, M., Madawanarachchi, S., Rai, B., Sattar, I., Silva, W., ...Chambers, J. C. (2021). The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial. Trials, 22(1), 928-. https://dx.doi.org/10.1186/s13063-021-05803-7
Journal: Trials
Abstract: Background: People from South Asia are at increased risk of type 2 diabetes (T2D). 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. Hypothesis: 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. Design: 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. Entry criteria: South Asian, men or women, age 40–70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0–6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. Endpoints: The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years 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. Intervention: Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (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. Results: 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 (SD 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). Conclusion: 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. IRB approval: 16/WM/0171. Trial registration: EudraCT 2016-001350-18. Registered on 14 April 2016. ClinicalTrials.gov NCT02949739. Registered on 31 October 2016, First posted on 31/10/2016.
URI: https://hdl.handle.net/10356/163013
ISSN: 1745-6215
DOI: 10.1186/s13063-021-05803-7
Rights: © The Author(s). 2021 Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Fulltext Permission: open
Fulltext Availability: With Fulltext
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