학술논문
The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial
Document Type
article
Author
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. Chambers
Source
Trials, Vol 22, Iss 1, Pp 1-13 (2021)
Subject
Language
English
ISSN
1745-6215
Abstract
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