A peer-support lifestyle intervention for preventing type 2 diabetes in India

A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program

Kavumpurathu R Thankappan, Thirunavukkarasu Sathish, Robyn Tapp, Jonathan Shaw, Mojtaba Lotfaliany, Rory Wolfe, Pilvikki Absetz, Elezebeth Mathews, Zahra Aziz, Emily D. Williams, Edwin B Fisher, Paul Z. Zimmet, Ajay Mahal, Sajitha Balachandran, Fabrizio D'Esposito, Priyanka Sajeev, Emma Thomas, Brian Oldenburg

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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.
Original languageEnglish
Article numbere1002575
Number of pages23
JournalPLoS Medicine
Volume15
Issue number6
DOIs
Publication statusPublished - 6 Jun 2018

Keywords

  • diabetes mellitus
  • diabetes prevention
  • physical activity
  • alcohol consumption
  • fruits
  • India
  • blood plasma
  • mental health and psychiatry

Cite this

Thankappan, Kavumpurathu R ; Sathish, Thirunavukkarasu ; Tapp, Robyn ; Shaw, Jonathan ; 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. In: PLoS Medicine. 2018 ; Vol. 15, No. 6.
@article{403f51cd1d994845bb080b2f88c23402,
title = "A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program",
abstract = "BackgroundThe 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 findingsThe 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.ConclusionsA 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.",
keywords = "diabetes mellitus, diabetes prevention, physical activity, alcohol consumption, fruits, India, blood plasma, mental health and psychiatry",
author = "Thankappan, {Kavumpurathu R} and Thirunavukkarasu Sathish and Robyn Tapp and Jonathan Shaw and Mojtaba Lotfaliany and Rory Wolfe and Pilvikki Absetz and Elezebeth Mathews and Zahra Aziz and Williams, {Emily D.} and Fisher, {Edwin B} and Zimmet, {Paul Z.} and Ajay Mahal and Sajitha Balachandran and Fabrizio D'Esposito and Priyanka Sajeev and Emma Thomas and Brian Oldenburg",
year = "2018",
month = "6",
day = "6",
doi = "10.1371/journal.pmed.1002575",
language = "English",
volume = "15",
journal = "PLoS Medicine",
issn = "1549-1676",
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number = "6",

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Thankappan, KR, Sathish, T, Tapp, R, Shaw, J, Lotfaliany, M, Wolfe, R, Absetz, P, Mathews, E, Aziz, Z, Williams, ED, Fisher, EB, Zimmet, PZ, Mahal, A, Balachandran, S, D'Esposito, F, Sajeev, P, Thomas, E & Oldenburg, B 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, vol. 15, no. 6, e1002575. https://doi.org/10.1371/journal.pmed.1002575

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; Shaw, Jonathan; 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 .

In: PLoS Medicine, Vol. 15, No. 6, e1002575, 06.06.2018.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - A peer-support lifestyle intervention for preventing type 2 diabetes in India

T2 - A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program

AU - Thankappan, Kavumpurathu R

AU - Sathish, Thirunavukkarasu

AU - Tapp, Robyn

AU - Shaw, Jonathan

AU - Lotfaliany, Mojtaba

AU - Wolfe, Rory

AU - Absetz, Pilvikki

AU - Mathews, Elezebeth

AU - Aziz, Zahra

AU - Williams, Emily D.

AU - Fisher, Edwin B

AU - Zimmet, Paul Z.

AU - Mahal, Ajay

AU - Balachandran, Sajitha

AU - D'Esposito, Fabrizio

AU - Sajeev, Priyanka

AU - Thomas, Emma

AU - Oldenburg, Brian

PY - 2018/6/6

Y1 - 2018/6/6

N2 - BackgroundThe 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 findingsThe 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.ConclusionsA 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.

AB - BackgroundThe 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 findingsThe 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.ConclusionsA 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.

KW - diabetes mellitus

KW - diabetes prevention

KW - physical activity

KW - alcohol consumption

KW - fruits

KW - India

KW - blood plasma

KW - mental health and psychiatry

U2 - 10.1371/journal.pmed.1002575

DO - 10.1371/journal.pmed.1002575

M3 - Article

VL - 15

JO - PLoS Medicine

JF - PLoS Medicine

SN - 1549-1676

IS - 6

M1 - e1002575

ER -