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Kasturiratne A, Khawaja KI, 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. 2021;22(1):928doi: 10.1186/s13063-021-05803-7.
Kasturiratne, A., Khawaja, K. I., Ahmad, S., Siddiqui, S., Shahzad, K., Athauda, L. K., Jayawardena, R., Mahmood, S., Muilwijk, M., Batool, T., Burney, S., Glover, M., Palaniswamy, S., Bamunuarachchi, V., Panda, M., Madawanarachchi, S., Rai, B., Sattar, I., Silva, W., Waghdhare, S., Jarvelin, M. R., Rannan-Eliya, R. P., Gage, H. M., van Valkengoed, I. G. M., Valabhji, J., Frost, G. S., Loh, M., Wickremasinghe, A. R., Kooner, J. S., Katulanda, P., Jha, S., & Chambers, J. C. (2021). 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(1), 928. https://doi.org/10.1186/s13063-021-05803-7
Kasturiratne, Anuradhani, 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 vol. 22,1 (2021): 928. doi: https://doi.org/10.1186/s13063-021-05803-7
Kasturiratne A, Khawaja KI, Ahmad S, Siddiqui S, Shahzad K, Athauda LK, Jayawardena R, Mahmood S, Muilwijk M, Batool T, Burney S, Glover M, Palaniswamy S, Bamunuarachchi V, Panda M, Madawanarachchi S, Rai B, Sattar I, Silva W, Waghdhare S, Jarvelin MR, Rannan-Eliya RP, Gage HM, van Valkengoed IGM, Valabhji J, Frost GS, Loh M, Wickremasinghe AR, Kooner JS, Katulanda P, Jha S, Chambers JC. 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. 2021 Dec 18;22(1):928. doi: 10.1186/s13063-021-05803-7. PMID: 34922608.
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Trials. 2021 Dec 18;22(1):928. doi: 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.

Trials

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

Affiliations

  1. Department of Public Health, Faculty of Medicine, University of Kelaniya, PO Box 06, Thalagolla Road, Ragama, 11010, Sri Lanka.
  2. Department of Endocrinology & Metabolism, Services Institute of Medical Sciences, Services Hospital, Ghaus ul Azam, Jail Road, Lahore, 54700, Pakistan.
  3. Punjab Institute of Cardiology, Jail Road, Lahore, Pakistan.
  4. Institute of Endocrinology, Diabetes & Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket, New Delhi, 110017, India.
  5. Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
  6. Department of Public and Occupational Health, Amsterdam Public Health research institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
  7. Department of Endocrinology & Metabolism, Diabetes Management Centre, Services Hospital, Ghaus-ul-Azam, Jail Road, Lahore, 540000, Pakistan.
  8. School of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Daphne Jackson Road, Guildford, GU2 7WG, Surrey, England.
  9. School of Public Health, Epidemiology and Biostatistics, Imperial College London, St Mary's Campus, Norfolk Place, London, W2 1PG, UK.
  10. Center for Life Course Health Research, Faculty of Medicine, University of Oulu, Oulu, Finland.
  11. Diabetes Research Unit, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
  12. Department of Life Sciences, College of Health and Life Sciences, Brunel University London, Kingston Lane, Uxbridge, Middlesex, UB8 3PH, UK.
  13. Unit of Primary Care, Oulu University Hospital, Oulu, Finland.
  14. Institute for Health Policy, 72 Park Street, Colombo, 00200, Sri Lanka.
  15. Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Leggett Building, Daphne Jackson Road, Guildford, GU2 7WG, Surrey, England.
  16. Department of Diabetes and Endocrinology, 1st Floor Mint Wing, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, W2 1NY, UK.
  17. 6th Floor Commonwealth Building, Faculty of Medicine, Imperial College London, Hammersmith Campus, Ducane Road, London, W12 ONN, UK.
  18. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, 308232, Singapore.
  19. National Heart and Lung Institute, Imperial College London, Hammersmith Hopsital Campus, Ducane Road, London, W12 ONN, UK.
  20. , Uxbridge Road, Southall, Middlesex, UB1 3HW, UK.
  21. Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
  22. School of Public Health, Epidemiology and Biostatistics, Imperial College London, St Mary's Campus, Norfolk Place, London, W2 1PG, UK. [email protected].
  23. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, 308232, Singapore. [email protected].

PMID: 34922608 DOI: 10.1186/s13063-021-05803-7

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/m

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.

IRB APPROVAL: 16/WM/0171 TRIAL REGISTRATION: EudraCT 2016-001350-18 . Registered on 14 April 2016. ClinicalTrials.gov NCT02949739 . Registered on 31 October 2016, First posted on 31/10/2016.

© 2021. The Author(s).

References

  1. Unnikrishnan R, Gupta PK, Mohan V. Diabetes in South Asians: phenotype, clinical presentation, and natural history. Curr Diab Rep. 2018;18(6):30. https://doi.org/10.1007/s11892-018-1002-8 . - PubMed
  2. Pradeepa R, Mohan V. Prevalence of type 2 diabetes and its complications in India and economic costs to the nation. Eur J Clin Nutr. 2017;71(7):816–24. https://doi.org/10.1038/ejcn.2017.40 . - PubMed
  3. Anjana RM, Deepa M, Pradeepa R, Mahanta J, Narain K, Das HK, et al. Prevalence of diabetes and prediabetes in 15 states of India: results from the ICMR-INDIAB population-based cross-sectional study. Lancet Diabetes Endocrinol. 2017;5(8):585–96. https://doi.org/10.1016/S2213-8587(17)30174-2 . - PubMed
  4. Hills AP, Arena R, Khunti K, Yajnik CS, Jayawardena R, Henry CJ, et al. Epidemiology and determinants of type 2 diabetes in south Asia. Lancet Diabetes Endocrinol. 2018;6(12):966–78. https://doi.org/10.1016/S2213-8587(18)30204-3 . - PubMed
  5. Sattar N, Gill JM. Type 2 diabetes in migrant south Asians: mechanisms, mitigation, and management. Lancet Diabetes Endocrinol. 2015;3(12):1004–16. https://doi.org/10.1016/S2213-8587(15)00326-5 . - PubMed
  6. Chambers JC, Loh M, Lehne B, Drong A, Kriebel J, Motta V, et al. Epigenome-wide association of DNA methylation markers in peripheral blood from Indian Asians and Europeans with incident type 2 diabetes: a nested case-control study. Lancet Diabetes Endocrinol. 2015;3(7):526–34. https://doi.org/10.1016/S2213-8587(15)00127-8 . - PubMed
  7. Diabetes Prevention Program Research, G. Effects of withdrawal from metformin on the development of diabetes in the diabetes prevention program. Diabetes Care. 2003;26(4):977–80. https://doi.org/10.2337/diacare.26.4.977 . - PubMed
  8. Diabetes Prevention Program Research, G. Long-term safety, tolerability, and weight loss associated with metformin in the Diabetes Prevention Program Outcomes Study. Diabetes Care 35, 731-737, doi: https://doi.org/10.2337/dc11-1299 (2012). - PubMed
  9. Jenum AK, Brekke I, Mdala I, Muilwijk M, Ramachandran A, Kjøllesdal M, et al. Effects of dietary and physical activity interventions on the risk of type 2 diabetes in South Asians: meta-analysis of individual participant data from randomised controlled trials. Diabetologia. 2019;62(8):1337–48. https://doi.org/10.1007/s00125-019-4905-2 . - PubMed
  10. Jeet G, Thakur JS, Prinja S, Singh M. Community health workers for non-communicable diseases prevention and control in developing countries: evidence and implications. PLoS One. 2017;12(7):e0180640. https://doi.org/10.1371/journal.pone.0180640 . - PubMed
  11. Abdel-All M, Thrift AG, Riddell M, Thankappan KRT, Mini GK, Chow CK, et al. Evaluation of a training program of hypertension for accredited social health activists (ASHA) in rural India. BMC Health Serv Res. 2018;18(1):320. https://doi.org/10.1186/s12913-018-3140-8 . - PubMed
  12. Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, et al. A community-based intervention for managing hypertension in rural South Asia. N Engl J Med. 2020;382(8):717–26. https://doi.org/10.1056/NEJMoa1911965 . - PubMed
  13. Gruber KJ, Haldeman LA. Using the family to combat childhood and adult obesity. Prev Chronic Dis. 2009;6:A106. - PubMed
  14. Pamungkas RA, Chamroonsawasdi K, Vatanasomboon P. A systematic review: family support integrated with diabetes self-management among uncontrolled type II diabetes mellitus patients. 2017;7(Behav Sci (Basel)). https://doi.org/10.3390/bs7030062 . - PubMed
  15. Jaber R, Braksmajer A, Trilling JS. Group visits: a qualitative review of current research. J Am Board Fam Med. 2006;19(3):276–90. https://doi.org/10.3122/jabfm.19.3.276 . - PubMed
  16. Soares Pires F, Drummond M, Marinho A, Sampaio R, Pinto T, Gonçalves M, et al. Effectiveness of a group education session on adherence with APAP in obstructive sleep apnea--a randomized controlled study. Sleep Breath. 2013;17(3):993–1001. https://doi.org/10.1007/s11325-012-0789-9 . - PubMed
  17. Ferrara A, Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Feng J, et al. A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial. Lancet Diabetes Endocrinol. 2020;8(6):490–500. https://doi.org/10.1016/S2213-8587(20)30107-8 . - PubMed
  18. Muilwijk, M. et al. The iHealth-T2D study: statistical analysis plan for a cluster randomised controlled trial with intensive family-based lifestyle modification programme to reduce type 2 diabetes risk amongst South Asians. MedRxiv. 2020.11.12.20229849. - PubMed
  19. Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2(3):109–12. https://doi.org/10.4103/2229-3485.83221 . - PubMed
  20. Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018;14(2):88–98. https://doi.org/10.1038/nrendo.2017.151 . - PubMed
  21. Thankappan KR, Sathish T, Tapp RJ, Shaw JE, Lotfaliany M, Wolfe R, et al. A peer-support lifestyle intervention for preventing type 2 diabetes in India: a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program. PLoS Med. 2018;15(6):e1002575. https://doi.org/10.1371/journal.pmed.1002575 . - PubMed
  22. Nanditha A, Thomson H, Susairaj P, Srivanichakorn W, Oliver N, Godsland IF, et al. A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial. Diabetologia. 2020;63(3):486–96. https://doi.org/10.1007/s00125-019-05061-y . - PubMed

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