KDPP
Phase 4
Completed
- Registration Number
- CTRI/2017/09/009895
- Lead Sponsor
- World Diabetes Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Individuals (both women and men) 18 years and above irrespective of their religion / caste.
2. Individuals who belong to the 3 districts (Kollam, Ernakulam and Kannur) where intervention is taking place.
3. Individuals who do not belong to Kudumbashree mission.
Exclusion Criteria
1. Individuals who are less than 18 years.
2. Individuals who belong to other districts (than the 3 where the study is set).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.120 KSM trainers trained to build capacity of Peer Leaders for KDPP delivery. <br/ ><br>2.15,000 Peer-Leaders trained in the delivery of KDPP. <br/ ><br>3.KDPP delivered to 375,000 men and women from 15,000 neighbourhoods in 3 regions of Kerala. <br/ ><br>4.75% of group participants attending at least 50% of the small group sessions. <br/ ><br>Timepoint: 1-3 years
- Secondary Outcome Measures
Name Time Method 5.25%of group participants attending at least 75% of small group sessions. <br/ ><br>6.No weight gain among program participants over 12 months. <br/ ><br>7.A reduction in waist circumference of at least 2.3 cm over 12 months. <br/ ><br>8.A reduction of those consuming tobacco and/or alcohol by at least 5.5% over 12 months. <br/ ><br>Timepoint: 12 months;9.At least 50% of participants walking for 30 minutes or more at least 5 times a week. <br/ ><br>10.At least 50% of participants achieving individualised dietary targets set with Peer-Leaders. <br/ ><br>11.Reduced progression towards diabetes based on fasting plasma glucose and oral glucose tolerance test (in a subset of 300 individuals). <br/ ><br>12.Reduction in triglycerides level of 0.06 mmol or more (in a subset of 300 individuals). <br/ ><br>Timepoint: 12 months