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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 Jul 12, 2018

Thankappan KR, et al. - The effectiveness of a peer-support lifestyle intervention in preventing type 2 diabetes was assessed among high-risk individuals identified on the basis of a simple diabetes risk score. Observations revealed a nonsignificant reduction in diabetes incidence in this high-risk population at 24 months in association with a low-cost community-based peer-support lifestyle intervention. Researchers, however, identified significant improvements in some cardiovascular risk factors and physical functioning score of the health-related quality of life (HRQoL) scale.

Methods

  • Researchers undertook the Kerala Diabetes Prevention Program which 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) comprised of individuals with an Indian Diabetes Risk Score (IDRS) ≥60 and those who were free of diabetes on an oral glucose tolerance test (OGTT).
  • They enrolled a total of 1,007 participants (47.2% female); 507 in the control group and 500 in the intervention group.
  • Intervention cluster participants were made to participate 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.
  • An education booklet with lifestyle change advice was provided to the participants from control clusters.
  • The incidence of diabetes at 24 months, diagnosed by an annual OGTT was assessed as the primary outcome.
  • Behavioral, clinical, and biochemical characteristics and HRQoL were assessed as the secondary outcomes.

Results

  • At 24 months, researchers followed up a total of 964 (95.7%) participants.
  • The study groups were similar in terms of baseline characteristics of clusters and participants.
  • In 17.1% (79/463) of control participants and 14.9% (68/456) of intervention participants, diabetes developed after a median follow-up of 24 months (relative risk [RR] 0.88, 95% CI 0.66–1.16, p=0.36).
  • At 24 months, intervention participants vs the control group displayed 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).
  • Cost of delivering the peer-support intervention was US$22.5 per participant in this work .
  • The intervention led to no adverse event.
  • They made no adjustment for multiple comparisons, which may have increased the overall type I error rate.

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