Cluster Randomised Controlled Trial of Community-based Diabetes Prevention: the Kerala Diabetes Prevention Program

INTRODUCTION: After China, India has the largest number of people with Type 2 Diabetes Mellitus. We describe findings from a study which is evaluating a “real world” community-based diabetes prevention program in rural Kerala, India which is adapted from the Finnish GOAL program.

METHODS: A total of 60 rural neighbourhoods (“clusters”) are randomised to intervention or control arm. Participants at “high risk” of diabetes are recruited in 2 steps. (1) If people aged 30-60 years have an Indian Diabetes Risk Score (IDRS) value of ≥60, they are invited to attend a mobile clinic (HOME SCREENING). (2) At the clinic they complete questionnaires, undergo physical measurements, and provide blood samples (MOBILE CLINIC). Participants in intervention arm participate in a group-based, lay peer support intervention program over 12 months to motivate, guide and support planning, initiation and maintenance of lifestyle changes aimed at reducing diabetes risk. Participants in the control arm are provided with a health education booklet. Follow-up assessments are conducted at 12 and 24 months.

RESULTS: About 3202 individuals underwent home screening, 44% (n=1410) of these had an IDRS ≥60. About 86% (n=1211) of these individuals attended the mobile clinic. Two hundred were excluded as having diabetes, leaving 1011 participants in the trial with an average cluster size of 17. Intervention fidelity is very good in 29/30 intervention clusters and intervention feasibility and acceptability is high.

CONCLUSIONS: Results from this trial will contribute to improved policy and practice regarding community-based diabetes prevention programs in India and other resource-constrained settings.