A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program

Background: The major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the...

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Main Authors: Thankappan, Kavumpurathu R., Sathish, Thirunavukkarasu, Tapp, Robyn J., Shaw, Jonathan E., Lotfaliany, Mojtaba, Wolfe, Rory, Absetz, Pilvikki, Mathews, Elezebeth, Aziz, Zahra, Williams, Emily D., Fisher, Edwin B., Zimmet, Paul Z., Mahal, Ajay, Balachandran, Sajitha, D'Esposito, Fabrizio, Sajeev, Priyanka, Thomas, Emma, Oldenburg, Brian
Other Authors: Gregg, Ed
Format: Journal Article
Language:English
Published: 2018
Subjects:
Online Access:https://hdl.handle.net/10356/87693
http://hdl.handle.net/10220/45526
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author Thankappan, Kavumpurathu R.
Sathish, Thirunavukkarasu
Tapp, Robyn J.
Shaw, Jonathan E.
Lotfaliany, Mojtaba
Wolfe, Rory
Absetz, Pilvikki
Mathews, Elezebeth
Aziz, Zahra
Williams, Emily D.
Fisher, Edwin B.
Zimmet, Paul Z.
Mahal, Ajay
Balachandran, Sajitha
D'Esposito, Fabrizio
Sajeev, Priyanka
Thomas, Emma
Oldenburg, Brian
author2 Gregg, Ed
author_facet Gregg, Ed
Thankappan, Kavumpurathu R.
Sathish, Thirunavukkarasu
Tapp, Robyn J.
Shaw, Jonathan E.
Lotfaliany, Mojtaba
Wolfe, Rory
Absetz, Pilvikki
Mathews, Elezebeth
Aziz, Zahra
Williams, Emily D.
Fisher, Edwin B.
Zimmet, Paul Z.
Mahal, Ajay
Balachandran, Sajitha
D'Esposito, Fabrizio
Sajeev, Priyanka
Thomas, Emma
Oldenburg, Brian
author_sort Thankappan, Kavumpurathu R.
collection NTU
description Background: The major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score. Methods and findings: The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30–60 years) were those with an Indian Diabetes Risk Score (IDRS) ≥60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66–1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: −1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (≥5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate. Conclusions: A low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale.
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spelling ntu-10356/876932020-11-01T05:26:03Z A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program Thankappan, Kavumpurathu R. Sathish, Thirunavukkarasu Tapp, Robyn J. Shaw, Jonathan E. Lotfaliany, Mojtaba Wolfe, Rory Absetz, Pilvikki Mathews, Elezebeth Aziz, Zahra Williams, Emily D. Fisher, Edwin B. Zimmet, Paul Z. Mahal, Ajay Balachandran, Sajitha D'Esposito, Fabrizio Sajeev, Priyanka Thomas, Emma Oldenburg, Brian Gregg, Ed Lee Kong Chian School of Medicine (LKCMedicine) Centre for Population Health Sciences IGT Lifestyle Interventions Background: The major efficacy trials on diabetes prevention have used resource-intensive approaches to identify high-risk individuals and deliver lifestyle interventions. Such strategies are not feasible for wider implementation in low- and middle-income countries (LMICs). We aimed to evaluate the effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes among high-risk individuals identified on the basis of a simple diabetes risk score. Methods and findings: The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial conducted in 60 polling areas (clusters) of Neyyattinkara taluk (subdistrict) in Trivandrum district, Kerala state, India. Participants (age 30–60 years) were those with an Indian Diabetes Risk Score (IDRS) ≥60 and were free of diabetes on an oral glucose tolerance test (OGTT). A total of 1,007 participants (47.2% female) were enrolled (507 in the control group and 500 in the intervention group). Participants from intervention clusters participated in a 12-month community-based peer-support program comprising 15 group sessions (12 of which were led by trained lay peer leaders) and a range of community activities to support lifestyle change. Participants from control clusters received an education booklet with lifestyle change advice. The primary outcome was the incidence of diabetes at 24 months, diagnosed by an annual OGTT. Secondary outcomes were behavioral, clinical, and biochemical characteristics and health-related quality of life (HRQoL). A total of 964 (95.7%) participants were followed up at 24 months. Baseline characteristics of clusters and participants were similar between the study groups. After a median follow-up of 24 months, diabetes developed in 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants (relative risk [RR] 0.88, 95% CI 0.66–1.16, p = 0.36). At 24 months, compared with the control group, intervention participants had a greater reduction in IDRS score (mean difference: −1.50 points, p = 0.022) and alcohol use (RR 0.77, p = 0.018) and a greater increase in fruit and vegetable intake (≥5 servings/day) (RR 1.83, p = 0.008) and physical functioning score of the HRQoL scale (mean difference: 3.9 score, p = 0.016). The cost of delivering the peer-support intervention was US$22.5 per participant. There were no adverse events related to the intervention. We did not adjust for multiple comparisons, which may have increased the overall type I error rate. Conclusions: A low-cost community-based peer-support lifestyle intervention resulted in a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months. However, there were significant improvements in some cardiovascular risk factors and physical functioning score of the HRQoL scale. Published version 2018-08-07T08:11:54Z 2019-12-06T16:47:23Z 2018-08-07T08:11:54Z 2019-12-06T16:47:23Z 2018 Journal Article Thankappan, K. R., Sathish, T., Tapp, R. J., Shaw, J. E., Lotfaliany, M., Wolfe, R., et al. (2018). A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program. PLOS Medicine, 15(6), e1002575-. 1549-1277 https://hdl.handle.net/10356/87693 http://hdl.handle.net/10220/45526 10.1371/journal.pmed.1002575 en PLOS Medicine © 2018 Thankappan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. 23 p. application/pdf
spellingShingle IGT
Lifestyle Interventions
Thankappan, Kavumpurathu R.
Sathish, Thirunavukkarasu
Tapp, Robyn J.
Shaw, Jonathan E.
Lotfaliany, Mojtaba
Wolfe, Rory
Absetz, Pilvikki
Mathews, Elezebeth
Aziz, Zahra
Williams, Emily D.
Fisher, Edwin B.
Zimmet, Paul Z.
Mahal, Ajay
Balachandran, Sajitha
D'Esposito, Fabrizio
Sajeev, Priyanka
Thomas, Emma
Oldenburg, Brian
A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
title A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
title_full A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
title_fullStr A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
title_full_unstemmed A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
title_short A peer-support lifestyle intervention for preventing type 2 diabetes in India : a cluster-randomized controlled trial of the Kerala Diabetes Prevention Program
title_sort peer support lifestyle intervention for preventing type 2 diabetes in india a cluster randomized controlled trial of the kerala diabetes prevention program
topic IGT
Lifestyle Interventions
url https://hdl.handle.net/10356/87693
http://hdl.handle.net/10220/45526
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