University of Oulu

Muilwijk, M., Loh, M., Mahmood, S. et al. The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes—a statistical analysis plan. Trials 23, 755 (2022). https://doi.org/10.1186/s13063-022-06667-1

The iHealth-T2D study : a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: a statistical analysis plan

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Author: Muilwijk, Mirthe1,2; Loh, Marie3,4; Mahmood, Sara5;
Organizations: 1Department of Public Health, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, Amsterdam, The Netherlands
2Amsterdam Public Health, Health Behaviours & Cardiovascular Diseases, Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands
3Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, 308232, Singapore
4Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, St Mary’s Campus, Norfolk Place, London, W2 1PG, UK
5Department of Endocrinology & Metabolism, Services Institute of Medical Sciences, Services Institute of Medical Sciences, Services Hospital, Ghaus Ul Azam, Jail Road 54700, Lahore, Pakistan
6Center for Life Course Health Research, Faculty of Medicine, University of Oulu, Oulu, Finland
7Max Healthcare, Institute of Endocrinology, Diabetes and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Skaet, New Delhi, 110017, India
8Faculty of Medicine, Imperial College London, Hammersmith Campus, DuCane Road, London, W12 ONN, UK
9Department of Clinical and Experimental Medicine, Surrey Health Economics Centre, University of Surrey, Leggett Building, Daphne Jackson Road, Guildford, Surrey, GU2 7WG, UK
10Unit of Primary Care, Oulu University Hospital, University of Oulu, Oulu, Finland
11Department of Life Sciences, College of Health and Life Sciences, Brunel University London, Kingston Lane, Uxbridge, UB8 3PH, Middlesex, UK
12Institute for Health Policy, 72 Park Street, Colombo, 00200, Sri Lanka
13Punjab Institute of Cardiology, Punjab Institute of Cardiology, Jail Road, Shadman, Lahore, Punjab, Pakistan
14Faculty of Medicine, University of Kelaniya, Thalagolla Road, PO Box 06, Ragama, 11010, Sri Lanka
15Department of Clinical Medicine, Faculty of Medicine, University of Colombo, 25 Kynsey Rd, Colombo, 00800, Sri Lanka
16London Northwest University Healthcare NHS Trust, Uxbridge Road, Southall, UB1 3HW, Middlesex, UK
17National Heart and Lung Institute, Imperial College London, Hammersmith Campus, DuCane Road, London, W12 ONN, UK
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 1.4 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe202301235240
Language: English
Published: Springer Nature, 2022
Publish Date: 2023-01-23
Description:

Abstract

Background: South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.

Methods: The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.

Discussion: The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.

Ethics and dissemination: The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.

Trial registration: EudraCT 2016–001,350-18. Registered on 14 April 2016. ClinicalTrials.gov NCT02949739. Registered on 31 October 2016.

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Series: Trials
ISSN: 1745-6215
ISSN-E: 1745-6215
ISSN-L: 1745-6215
Volume: 23
Article number: 755
DOI: 10.1186/s13063-022-06667-1
OADOI: https://oadoi.org/10.1186/s13063-022-06667-1
Type of Publication: A1 Journal article – refereed
Field of Science: 3142 Public health care science, environmental and occupational health
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.
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
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