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BMJ Glob Health. 2021 Nov;6(11). doi: 10.1136/bmjgh-2021-006479.

Effects of a lifestyle intervention programme after 1 year of follow-up among South Asians at high risk of type 2 diabetes: a cluster randomised controlled trial.

BMJ global health

Mirthe Muilwijk, Marie Loh, Samreen Siddiqui, Sara Mahmood, Saranya Palaniswamy, Khurram Shahzad, Lathika K Athauda, Ranil Jayawardena, Tayyaba Batool, Saira Burney, Matthew Glover, Vodathi Bamunuarachchi, Manju Panda, Madawa Madawanarachchi, Baldeesh Rai, Iqra Sattar, Wnurinham Silva, Swati Waghdhare, Marjo-Riitta Jarvelin, Ravindra Prasan Rannan-Eliya, Nilmini Wijemunige, Heather M Gage, Jonathan Valabhji, Gary S Frost, Rajitha Wickremasinghe, Anuradhani Kasturiratne, Khadija I Khawaja, Sajjad Ahmad, Irene Gm van Valkengoed, Prasad Katulanda, Sujeet Jha, Jaspal S Kooner, John C Chambers

Affiliations

  1. Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands [email protected].
  2. Lee Kon Chian School of Medicine, Nanyang Technological University, Singapore.
  3. Department of Epidemiology and Biostatistics, Imperial College London, London, UK.
  4. Institute of Endocrinology Diabetes and Metabolism, Max Healthcare, New Delhi, Delhi, India.
  5. Department of Endocrinology & Metabolism, Services Institute of Medical Sciences, Lahore, Punjab, Pakistan.
  6. Center for Life Course Health Research, Faculty of Medicine, University of Oulu, Oulu, Finland.
  7. Punjab Institute of Cardiology, Lahore, Punjab, Pakistan.
  8. Department of Public Health, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.
  9. Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Western, Sri Lanka.
  10. Department of Endocrinology and Metabolism, Services Institute of Medical Sciences, Lahore, Punjab, Pakistan.
  11. School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, UK.
  12. Diabetes Research Unit, Faculty of Medicine, University of Colombo, Colombo, Western, Sri Lanka.
  13. School of Public Health, Imperial College London, London, UK.
  14. Department of Life Sciences, College of Health and Life Sciences, Brunel University, London, UK.
  15. Unit of Primary Care, Oulu University Hospital, Oulu, Finland.
  16. Institute for Health Policy, Colombo, Sri Lanka.
  17. Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, Surrey, UK.
  18. Department of Diabetes and Endocrinology, Imperial College London, London, UK.
  19. Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
  20. Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.
  21. Department of Clinical Medicine, University of Colombo, Colombo, Sri Lanka.
  22. London North West University Healthcare NHS Trust, Harrow, London, UK.
  23. National Heart & Lung Institute, Faculty of Medicine, Imperial College London, London, UK.

PMID: 34725039 PMCID: PMC8562508 DOI: 10.1136/bmjgh-2021-006479

Abstract

INTRODUCTION: South Asians are at high risk of type 2 diabetes (T2D). We assessed whether intensive family-based lifestyle intervention leads to significant weight loss, improved glycaemia and blood pressure in adults at elevated risk for T2D.

METHODS: This cluster randomised controlled trial (iHealth-T2D) was conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. We included 3684 South Asian men and women, aged 40-70 years, without T2D but with raised haemoglobin A1c (HbA1c) and/or waist circumference. Participants were randomly allocated either to the family-based lifestyle intervention or control group by location clusters. Participants in the intervention received 9 visits and 13 telephone contacts by community health workers over 1-year period, and the control group received usual care. Reductions in weight (aim >7% reduction), waist circumference (aim ≥5 cm reduction), blood pressure and HbA1C at 12 months of follow-up were assessed. Our linear mixed-effects regression analysis was based on intention-to-treat principle and adjusted for age, sex and baseline values.

RESULTS: There were 1846 participants in the control and 1838 in the intervention group. Between baseline and 12 months, mean weight of participants in the intervention group reduced by 1.8 kg compared with 0.4 kg in the control group (adjusted mean difference -1.10 kg (95% CI -1.70 to -1.06), p<0.001). The adjusted mean difference for waist circumference was -1.9 cm (95% CI -2.5; to 1.3), p<0.001). No overall difference was observed for blood pressure or HbA1c. People who attended multiple intervention sessions had a dose-dependent effect on waist circumference, blood pressure and HbA1c, but not on weight.

CONCLUSION: An intensive family-based lifestyle intervention adopting low-resource strategies led to effective reduction in weight and waist circumference at 12 months, which has potential long-term benefits for preventing T2D. A higher number of attended sessions increased the effect on waist circumference, blood pressure and HbA1c.

TRIAL REGISTRATION NUMBER: EudraCT: 2016-001350-18; ClinicalTrials.gov: NCT02949739.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: cluster randomized trial; diabetes; epidemiology; prevention strategies; public health

Conflict of interest statement

Competing interests: None declared.

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