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.

Details

Title
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
Author
Muilwijk, Mirthe 1   VIAFID ORCID Logo  ; Loh, Marie 2 ; Mahmood, Sara 3 ; Palaniswamy, Saranya 4 ; Siddiqui, Samreen 5 ; Silva, Wnurinham 6 ; Frost, Gary S. 7 ; Gage, Heather M. 8 ; Jarvelin, Marjo-Riitta 9 ; Rannan-Eliya, Ravindra P. 10 ; Ahmad, Sajjad 11 ; Jha, Sujeet 5 ; Kasturiratne, Anuradhani 12 ; Katulanda, Prasad 13 ; Khawaja, Khadija I. 3 ; Kooner, Jaspal S. 14 ; Wickremasinghe, Ananda R. 12 ; van Valkengoed, Irene G. M. 15 ; Chambers, John C. 2 

1  University of Amsterdam, Amsterdam Public Health Research Institute, Department of Public Health, Amsterdam UMC, Amsterdam, The Netherlands; Amsterdam Public Health, Health Behaviours & Cardiovascular Diseases, Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands 
2  Nanyang Technological University, Lee Kong Chian School of Medicine, Singapore, Singapore (GRID:grid.59025.3b) (ISNI:0000 0001 2224 0361); Imperial College London, St Mary’s Campus, Norfolk Place, Department of Epidemiology and Biostatistics, School of Public Health, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111) 
3  Services Institute of Medical Sciences, Services Hospital, Department of Endocrinology & Metabolism, Services Institute of Medical Sciences, Lahore, Pakistan (GRID:grid.460986.5) (ISNI:0000 0004 4904 5891) 
4  Imperial College London, St Mary’s Campus, Norfolk Place, Department of Epidemiology and Biostatistics, School of Public Health, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111); University of Oulu, Center for Life Course Health Research, Faculty of Medicine, Oulu, Finland (GRID:grid.10858.34) (ISNI:0000 0001 0941 4873) 
5  Max Super Speciality Hospital, Max Healthcare, Institute of Endocrinology, Diabetes and Metabolism, Skaet, India (GRID:grid.459746.d) (ISNI:0000 0004 1805 869X) 
6  Imperial College London, St Mary’s Campus, Norfolk Place, Department of Epidemiology and Biostatistics, School of Public Health, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111) 
7  Imperial College London, Faculty of Medicine, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111) 
8  University of Surrey, Department of Clinical and Experimental Medicine, Surrey Health Economics Centre, Surrey, UK (GRID:grid.5475.3) (ISNI:0000 0004 0407 4824) 
9  Imperial College London, St Mary’s Campus, Norfolk Place, Department of Epidemiology and Biostatistics, School of Public Health, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111); University of Oulu, Center for Life Course Health Research, Faculty of Medicine, Oulu, Finland (GRID:grid.10858.34) (ISNI:0000 0001 0941 4873); Oulu University Hospital, University of Oulu, Unit of Primary Care, Oulu, Finland (GRID:grid.10858.34) (ISNI:0000 0001 0941 4873); College of Health and Life Sciences, Brunel University London, Department of Life Sciences, Uxbridge, UK (GRID:grid.7728.a) (ISNI:0000 0001 0724 6933) 
10  Institute for Health Policy, Colombo, Sri Lanka (GRID:grid.7728.a) 
11  Punjab Institute of Cardiology, Punjab Institute of Cardiology, Punjab, Pakistan (GRID:grid.418815.1) (ISNI:0000 0004 0608 8752) 
12  University of Kelaniya, Faculty of Medicine, Ragama, Sri Lanka (GRID:grid.45202.31) (ISNI:0000 0000 8631 5388) 
13  University of Colombo, Department of Clinical Medicine, Faculty of Medicine, Colombo, Sri Lanka (GRID:grid.8065.b) (ISNI:0000000121828067) 
14  London Northwest University Healthcare NHS Trust, Southall, UK (GRID:grid.460986.5); National Heart and Lung Institute, Imperial College London, London, UK (GRID:grid.7445.2) (ISNI:0000 0001 2113 8111) 
15  University of Amsterdam, Amsterdam Public Health Research Institute, Department of Public Health, Amsterdam UMC, Amsterdam, The Netherlands (GRID:grid.45202.31); Amsterdam Public Health, Health Behaviours & Cardiovascular Diseases, Amsterdam Cardiovascular Sciences, Diabetes & Metabolism, Amsterdam, The Netherlands (GRID:grid.45202.31) 
Pages
755
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-022-06667-1
ProQuest document ID
2808563756
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.