![]() The Kerala Diabetes Prevention Program (K-DPP) is a cluster randomized trial of a group-based and peer-led lifestyle intervention among adults at high-risk for type 2 diabetes in Kerala, India. We also present the rationale to conduct a nine-year follow-up of the original K-DPP participants the aims, measures to be undertaken, and the analysis plan. ![]() In this study protocol paper, we briefly discuss the findings of a community-based diabetes prevention program conducted in the Indian state of Kerala, the Kerala Diabetes Prevention Program (K-DPP), from 2013–2016. In addition, there is limited evidence about their effects and sustainability after the active intervention phase. However, most of the trials have been conducted in high-income countries. The lifestyle interventions used in these implementation trials have been shown to be more effective when delivered via groups, such as peer support groups. A review of 38 implementation trials has demonstrated a reduction in type 2 diabetes incidence of between 40–60%. The efficacy, effectiveness, and implementation of lifestyle interventions aimed at preventing the onset of type 2 diabetes have been well-established at least in high-income countries. In this regard, the prevention and management of diabetes, through community-based approaches need urgent attention. Partly due to its large population size, India has the second-highest annual number of deaths from diabetes, approximately 0.6 million. About 57% of the estimated number of people with diabetes in India are undiagnosed. India has the second highest number of people with diabetes (74.2 million), accounting for 1 in 7 of all adults living with diabetes worldwide, and this is expected to increase to 124.9 million by 2045. Almost 90% of people with undiagnosed diabetes live in low- and middle-income countries. It is estimated that 94% of this increase will occur in low and middle-income countries. The global number of people with diabetes is projected to reach 783 million by 2045. Trial registrationĪustralia and New Zealand Clinical Trials Registry–(updated from the original trial)ACTRN12611000262909 India: CTRI/2091.īased on recent estimates, there are 537 million people with diabetes globally with 433 million (80.6%) living in low and middle-income countries such as India. Discussionįindings 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. Analysis of the long-term cost-effectiveness of the intervention is planned. Data analysis strategies include a comparison of outcome indicators with baseline, and follow-up measurements conducted at 12 and 24 months. Secondary outcomes include behavioral, psychosocial, clinical, biochemical, and retinal vasculature measures. The primary outcome is the incidence of T2DM. All data collection is being conducted by trained Nurses. In phase II, we are inviting participants to undergo retinal imaging, body composition measurements, and ECG. In phase 1 (Survey), we are admintsering a structured questionnaire, undertake physical measurements, and collect blood and urine samples for biochemical analysis. 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. 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. The overall aim of this study is to evaluate the long-term cardiometabolic effects of the Kerala Diabetes Prevention Program (K-DPP). ![]() Moreover, evidence on the impact of a diabetes prevention program on cardiovascular risk over time is limited. 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. 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. This is predicted to increase to 124.9 million by 2045. India currently has more than 74.2 million people with Type 2 Diabetes Mellitus (T2DM).
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