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  • 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

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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
  1. Mirthe Muilwijk1,
  2. Marie Loh2,3,
  3. Samreen Siddiqui4,
  4. Sara Mahmood5,
  5. Saranya Palaniswamy3,6,
  6. Khurram Shahzad7,
  7. Lathika K Athauda8,
  8. Ranil Jayawardena9,
  9. Tayyaba Batool10,
  10. Saira Burney5,
  11. Matthew Glover11,
  12. Vodathi Bamunuarachchi12,
  13. Manju Panda4,
  14. Madawa Madawanarachchi12,
  15. Baldeesh Rai13,
  16. Iqra Sattar7,
  17. Wnurinham Silva13,
  18. Swati Waghdhare4,
  19. Marjo-Riitta Jarvelin6,13,14,15,
  20. Ravindra Prasan Rannan-Eliya16,
  21. Nilmini Wijemunige16,
  22. Heather M Gage17,
  23. Jonathan Valabhji18,19,
  24. Gary S Frost19,
  25. Rajitha Wickremasinghe8,
  26. Anuradhani Kasturiratne8,
  27. Khadija I Khawaja5,
  28. Sajjad Ahmad7,
  29. Irene GM van Valkengoed1,
  30. Prasad Katulanda20,
  31. Sujeet Jha4,
  32. Jaspal S Kooner21,22,
  33. John C Chambers2,3
  1. 1Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands
  2. 2Lee Kon Chian School of Medicine, Nanyang Technological University, Singapore
  3. 3Department of Epidemiology and Biostatistics, Imperial College London, London, UK
  4. 4Institute of Endocrinology Diabetes and Metabolism, Max Healthcare, New Delhi, Delhi, India
  5. 5Department of Endocrinology & Metabolism, Services Institute of Medical Sciences, Lahore, Punjab, Pakistan
  6. 6Center for Life Course Health Research, Faculty of Medicine, University of Oulu, Oulu, Finland
  7. 7Punjab Institute of Cardiology, Lahore, Punjab, Pakistan
  8. 8Department of Public Health, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka
  9. 9Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Western, Sri Lanka
  10. 10Department of Endocrinology and Metabolism, Services Institute of Medical Sciences, Lahore, Punjab, Pakistan
  11. 11School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, UK
  12. 12Diabetes Research Unit, Faculty of Medicine, University of Colombo, Colombo, Western, Sri Lanka
  13. 13School of Public Health, Imperial College London, London, UK
  14. 14Department of Life Sciences, College of Health and Life Sciences, Brunel University, London, UK
  15. 15Unit of Primary Care, Oulu University Hospital, Oulu, Finland
  16. 16Institute for Health Policy, Colombo, Sri Lanka
  17. 17Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, Surrey, UK
  18. 18Department of Diabetes and Endocrinology, Imperial College London, London, UK
  19. 19Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK
  20. 20Department of Clinical Medicine, University of Colombo, Colombo, Sri Lanka
  21. 21London North West University Healthcare NHS Trust, Harrow, London, UK
  22. 22National Heart & Lung Institute, Faculty of Medicine, Imperial College London, London, UK
  1. Correspondence to Dr Mirthe Muilwijk; m.muilwijk{at}amsterdamumc.nl

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.

  • epidemiology
  • prevention strategies
  • public health
  • diabetes
  • cluster randomized trial

Data availability statement

Data are available upon reasonable request. Data will be available to others after de-identification, on completion of the research, by application to the Steering Committee.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjgh-2021-006479

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    Data availability statement

    Data are available upon reasonable request. Data will be available to others after de-identification, on completion of the research, by application to the Steering Committee.

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    Footnotes

    • Handling editor Seye Abimbola

    • Twitter @ravirannaneliya

    • Contributors GSF, HMG, M-RJ, RPR-E, SA, SJ, AK, PK, KIK, JSK, RW and JCC designed the iHealth-T2D trial. MM and IGMV designed the statistical approach. SJ was the lead investigator in India. SA and KIK were the lead investigators in Pakistan. PK, RW and RPR-E were the lead investigators in Sri Lanka. JCC, JSK and HMG were the lead investigators in the UK. MM performed the data analysis and drafted the first version of the manuscript. SP and IGMV reviewed and edited the manuscript. All authors reviewed the manuscript. All authors read and approved the final manuscript. JCC is the guarantor.

    • Funding The iHealth-T2D trial was funded by the European Commission (grant award 643774).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.