PMID- 36945029 OWN - NLM STAT- MEDLINE DCOM- 20230329 LR - 20230429 IS - 1471-2458 (Electronic) IS - 1471-2458 (Linking) VI - 23 IP - 1 DP - 2023 Mar 22 TI - The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk: a study protocol. PG - 539 LID - 10.1186/s12889-023-15392-6 [doi] LID - 539 AB - INTRODUCTION: India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM). This is predicted to increase to 124.9 million by 2045. In combination with controlling blood glucose levels among those with T2DM, preventing the onset of diabetes among those at high risk of developing it is essential. Although many diabetes prevention interventions have been implemented in resource-limited settings in recent years, there is limited evidence about their long-term effectiveness, cost-effectiveness, and sustainability. Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. OBJECTIVES: The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). Specific aims are 1) to measure the long-term effectiveness of K-DPP on diabetes incidence and cardiometabolic risk after nine years from participant recruitment; 2) to assess retinal microvasculature, microalbuminuria, and ECG abnormalities and their association with cardiometabolic risk factors over nine years of the intervention; 3) to evaluate the long-term cost-effectiveness and return on investment of the K-DPP; and 4) to assess the sustainability of community engagement, peer-support, and other related community activities after nine years. METHODS: The nine-year follow-up study aims to reach all 1007 study participants (500 intervention and 507 control) from 60 randomized polling areas recruited to the original trial. Data are being collected in two phases. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. All data collection is being conducted by trained Nurses. The primary outcome is the incidence of T2DM. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Analysis of the long-term cost-effectiveness of the intervention is planned. DISCUSSION: Findings from this follow-up study will contribute to improved policy and practice regarding the long-term effects of lifestyle interventions for diabetes prevention in India and other resource-limited settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry-(updated from the original trial)ACTRN12611000262909; India: CTRI/2021/10/037191. CI - (c) 2023. The Author(s). FAU - Haregu, Tilahun AU - Haregu T AD - Baker Heart and Diabetes Institute, Melbourne, Australia. tilahun.haregu@baker.edu.au. AD - Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. tilahun.haregu@baker.edu.au. FAU - Lekha, T R AU - Lekha TR AD - Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum, India. FAU - Jasper, Smitha AU - Jasper S AD - Christian Medical College, Vellore, India. FAU - Kapoor, Nitin AU - Kapoor N AD - Christian Medical College, Vellore, India. FAU - Sathish, Thirunavukkarasu AU - Sathish T AD - Department of Family and Preventive Medicine, School of Medicine, Emory University, Atlanta, GA, USA. FAU - Panniyammakal, Jeemon AU - Panniyammakal J AD - Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum, India. FAU - Tapp, Robyn AU - Tapp R AD - Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. AD - Research Centre for Intelligent Health Care, Coventry University, Coventry, UK. FAU - Thankappan, Kavumpurathu Raman AU - Thankappan KR AD - Amrita Institute of Medical Sciences, Kochi, Kerala, India. FAU - Mahal, Ajay AU - Mahal A AD - Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. FAU - Absetz, Pilvikki AU - Absetz P AD - Faculty of Social Sciences, Tampere University, Tampere, Finland. FAU - Fisher, Edwin B AU - Fisher EB AD - Gillings School of Global Public Health, University of North Carolina, Chapel Hill, USA. FAU - Oldenburg, Brian AU - Oldenburg B AD - Baker Heart and Diabetes Institute, Melbourne, Australia. AD - School of Psychology and Public Health, La Trobe University, Melbourne, Australia. LA - eng SI - ANZCTR/ACTRN12611000262909 GR - P30 DK092926/DK/NIDDK NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230322 PL - England TA - BMC Public Health JT - BMC public health JID - 100968562 SB - IM MH - Humans MH - *Cardiovascular Diseases/epidemiology/prevention & control MH - *Diabetes Mellitus, Type 2/epidemiology/prevention & control MH - Follow-Up Studies MH - Incidence MH - Life Style PMC - PMC10030347 OTO - NOTNLM OT - Cardiometabolic OT - Diabetes OT - India OT - Kerala OT - Long-term effects OT - Peer support OT - Sustainability COIS- The authors declare no competing interests. EDAT- 2023/03/23 06:00 MHDA- 2023/03/24 06:00 PMCR- 2023/03/22 CRDT- 2023/03/22 00:37 PHST- 2023/01/31 00:00 [received] PHST- 2023/03/07 00:00 [accepted] PHST- 2023/03/22 00:37 [entrez] PHST- 2023/03/23 06:00 [pubmed] PHST- 2023/03/24 06:00 [medline] PHST- 2023/03/22 00:00 [pmc-release] AID - 10.1186/s12889-023-15392-6 [pii] AID - 15392 [pii] AID - 10.1186/s12889-023-15392-6 [doi] PST - epublish SO - BMC Public Health. 2023 Mar 22;23(1):539. doi: 10.1186/s12889-023-15392-6.