A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program.
<h4>Background</h4>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 aim...
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| author | Kavumpurathu R Thankappan Thirunavukkarasu Sathish Robyn J Tapp Jonathan E 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 |
| author_facet | Kavumpurathu R Thankappan Thirunavukkarasu Sathish Robyn J Tapp Jonathan E 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 |
| author_sort | Kavumpurathu R Thankappan |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Australia and New Zealand Clinical Trials Registry ACTRN12611000262909. |
| format | Article |
| id | doaj-art-0e9f12c416d24b15a723f6ae0b13f5f1 |
| institution | DOAJ |
| issn | 1549-1277 1549-1676 |
| language | English |
| publishDate | 2018-06-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Medicine |
| spelling | doaj-art-0e9f12c416d24b15a723f6ae0b13f5f12025-08-20T03:11:25ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762018-06-01156e100257510.1371/journal.pmed.1002575A peer-support lifestyle intervention for preventing type 2 diabetes in India: A cluster-randomized controlled trial of the Kerala Diabetes Prevention Program.Kavumpurathu R ThankappanThirunavukkarasu SathishRobyn J TappJonathan E ShawMojtaba LotfalianyRory WolfePilvikki AbsetzElezebeth MathewsZahra AzizEmily D WilliamsEdwin B FisherPaul Z ZimmetAjay MahalSajitha BalachandranFabrizio D'EspositoPriyanka SajeevEmma ThomasBrian Oldenburg<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Australia and New Zealand Clinical Trials Registry ACTRN12611000262909.https://storage.googleapis.com/plos-corpus-prod/10.1371/journal.pmed.1002575/1/pmed.1002575.pdf?X-Goog-Algorithm=GOOG4-RSA-SHA256&X-Goog-Credential=wombat-sa%40plos-prod.iam.gserviceaccount.com%2F20210222%2Fauto%2Fstorage%2Fgoog4_request&X-Goog-Date=20210222T181848Z&X-Goog-Expires=3600&X-Goog-SignedHeaders=host&X-Goog-Signature=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 |
| spellingShingle | Kavumpurathu R Thankappan Thirunavukkarasu Sathish Robyn J Tapp Jonathan E 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 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 |
| 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 |
| url | https://storage.googleapis.com/plos-corpus-prod/10.1371/journal.pmed.1002575/1/pmed.1002575.pdf?X-Goog-Algorithm=GOOG4-RSA-SHA256&X-Goog-Credential=wombat-sa%40plos-prod.iam.gserviceaccount.com%2F20210222%2Fauto%2Fstorage%2Fgoog4_request&X-Goog-Date=20210222T181848Z&X-Goog-Expires=3600&X-Goog-SignedHeaders=host&X-Goog-Signature=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 |
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