University of Oulu

Kasturiratne, A., Khawaja, K.I., Ahmad, S. et al. 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, 928 (2021). https://doi.org/10.1186/s13063-021-05803-7

The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes : study protocol for a randomised controlled trial

Saved in:
Author: Kasturiratne, Anuradhani1; Khawaja, Khadija I.2; Ahmad, Sajjad3;
Organizations: 1Department of Public Health, Faculty of Medicine, University of Kelaniya, PO Box 06, Thalagolla Road, Ragama 11010, Sri Lanka.
2Department of Endocrinology & Metabolism, Services Institute of Medical Sciences, Services Hospital, Ghaus ul Azam, Jail Road, Lahore 54700, Pakistan.
3Punjab Institute of Cardiology, Jail Road, Lahore, Pakistan.
4Institute of Endocrinology, Diabetes & Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket, New Delhi 110017, India.
5Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
6Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
7Department of Endocrinology & Metabolism, Diabetes Management Centre, Services Hospital, Ghaus-ul-Azam, Jail Road, Lahore 540000, Pakistan.
8School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Daphne Jackson Road, Guildford, GU2 7WG Surrey, England.
9School of Public Health, Epidemiology and Biostatistics, Imperial College London, St Mary’s Campus, Norfolk Place, London W2 1PG, UK.
10Center for Life Course Health Research, Faculty of Medicine, University of Oulu, Oulu, Finland.
11Diabetes Research Unit, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
12Department of Life Sciences, College of Health and Life Sciences, Brunel University London, Kingston Lane, Uxbridge, Middlesex UB8 3PH, UK.
13Unit of Primary Care, Oulu University Hospital, Oulu, Finland.
14Institute for Health Policy, 72 Park Street, Colombo 00200, Sri Lanka.
15Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Leggett Building, Daphne Jackson Road, Guildford, GU2 7WG Surrey, England.
16Department of Diabetes and Endocrinology, 1st Floor Mint Wing, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London W2 1NY, UK.
176th Floor Commonwealth Building, Faculty of Medicine, Imperial College London, Hammersmith Campus, Ducane Road, London W12 ONN, UK.
18Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore.
19National Heart and Lung Institute, Imperial College London, Hammersmith Hopsital Campus, Ducane Road, London W12 ONN, UK.
20Uxbridge Road, Southall, Middlesex UB1 3HW, UK.
21Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 1.5 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe2022020918451
Language: English
Published: Springer Nature, 2021
Publish Date: 2022-02-09
Description:

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.

see all

Series: Trials
ISSN: 1745-6215
ISSN-E: 1745-6215
ISSN-L: 1745-6215
Volume: 22
Issue: 1
Article number: 928
DOI: 10.1186/s13063-021-05803-7
OADOI: https://oadoi.org/10.1186/s13063-021-05803-7
Type of Publication: A1 Journal article – refereed
Field of Science: 3142 Public health care science, environmental and occupational health
3121 General medicine, internal medicine and other clinical medicine
Subjects:
Funding: The research was supported by the European Union H2020 program (iHealth-T2D, 643774). JCC, JSK, GF, BR and WS are also supported in part by the National Institute for Health Research (NIHR) (16/136/68) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Social Care. The funding body had no role in the study design; the collection, management, analysis and interpretation of data; the writing of the report; and the decision to submit the report for publication. European Commission (award 643774) and National Institute for Health Research (award 16/136/68)
EU Grant Number: (643774) iHealth-T2D - Family-based intervention to improve healthy lifestyle and prevent Type 2 Diabetes amongst South Asians with central obesity and prediabetes
Copyright information: © 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.
  https://creativecommons.org/licenses/by/4.0/