TY - JOUR
T1 - The long-term effects of Kerala Diabetes Prevention Program on diabetes incidence and cardiometabolic risk
T2 - a study protocol
AU - Haregu, Tilahun
AU - Lekha, T. R.
AU - Jasper, Smitha
AU - Kapoor, Nitin
AU - Sathish, Thirunavukkarasu
AU - Panniyammakal, Jeemon
AU - Tapp, Robyn
AU - Thankappan, Kavumpurathu Raman
AU - Mahal, Ajay
AU - Absetz, Pilvikki
AU - Fisher, Edwin B.
AU - Oldenburg, Brian
N1 - Funding Information:
This study is funded by the Australian National Health and Medical Research Council (NHMRC) (Grant ID: 1160283). The funding body has no role in the design of the study and the writing the study protocol.
Funding Information:
K-DPP follow-up study is funded by the National Health & Medical Research Council (Grant ID: 1160283). We acknowledge Dr Yingting Cao, Dr GK Mini, Professor Sivasubramonian Sivasankaran, Kate Chalmers, Ameera Katar, and Rebecca Gracey for their contribution in the preparatory phase of the study. We also acknowledge Sree Chitra Trunal Institute for Medical Sciences and Technology the Melbourne School of Population and Global at the University of Melbourne, and Baker Heart and Diabetes Institute for their contribution to this study.
Funding Information:
K-DPP follow-up study is funded by the National Health & Medical Research Council (Grant ID: 1160283). We acknowledge Dr Yingting Cao, Dr GK Mini, Professor Sivasubramonian Sivasankaran, Kate Chalmers, Ameera Katar, and Rebecca Gracey for their contribution in the preparatory phase of the study. We also acknowledge Sree Chitra Trunal Institute for Medical Sciences and Technology the Melbourne School of Population and Global at the University of Melbourne, and Baker Heart and Diabetes Institute for their contribution to this study.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/3
Y1 - 2023/3
N2 - 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.
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.
KW - Cardiometabolic
KW - Diabetes
KW - India
KW - Kerala
KW - Long-term effects
KW - Peer support
KW - Sustainability
U2 - 10.1186/s12889-023-15392-6
DO - 10.1186/s12889-023-15392-6
M3 - Article
C2 - 36945029
AN - SCOPUS:85150916113
SN - 1471-2458
VL - 23
JO - BMC Public Health
JF - BMC Public Health
M1 - 539
ER -
