The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk: a study protocol

• Authors: Tilahun Haregu, Baker Heart and Diabetes Institute; T. R. Lekha, Sree Chitra Tirunal Institute for Medical Sciences and Technology; Smitha Jasper, Christian Medical College, Vellore; Nitin Kapoor, Christian Medical College, Vellore; Sathish Thirunavukkarasu, Emory University; Jeemon Panniyammakal, Sree Chitra Tirunal Institute for Medical Sciences and Technology; Robyn Tapp, Melbourne School of Population and Global Health; Kavumpurathu Raman Thankappan, Amrita Institute of Medical Sciences India; Ajay Mahal, Melbourne School of Population and Global Health; Pilvikki Absetz, Tampere University; Edwin B. Fisher, The University of North Carolina at Chapel Hill; Brian Oldenburg, Baker Heart and Diabetes Institute
• Journal Title: BMC Public Health
• Volume: Volume 23, Number 1
• Publisher: BMC | 2023-03-22, Pages 539-539
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1186/s12889-023-15392-6
• Subjects: Health Sciences, Nutrition; Health Sciences, Public Health
• Keywords: Cardiometabolic; Diabetes; India; Kerala; Long-term effects; Peer support; Sustainability; Humans; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Follow-Up Studies; Incidence; Life Style

Abstract

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.