Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.
Aims: The Diabetes Community Lifestyle Improvement Program (D-CLIP) aims to implement and
evaluate in a controlled, randomized trial the effectiveness, cost-effectiveness, and
sustainability of a culturally appropriate, low-cost, and sustainable lifestyle intervention
for the prevention of type 2 diabetes mellitus in India.
Methods: D-CLIP, a translational research project adapted from the methods and curriculum
developed and tested for efficacy in the Diabetes Prevention Program, utilizes innovated
methods (a step-wise model of diabetes prevention with lifestyle and metformin added when
needed; inclusion of individuals with isolated impaired glucose tolerance, isolated impaired
fasting glucose, and both; classes team-taught by professionals and trained community
educators) with the goals of increasing diabetes prevention, community acceptability, and
long-term dissemination and sustainability of the program. The primary outcome is, diabetes
incidence, and secondary outcomes are cost-effectiveness, changes in anthropometric
measures, plasma lipids, blood pressure, blood glucose, and HbA1c, and program acceptability
and sustainability assessed using a mixed methods approach.
Conclusion: D-CLIP, a low-cost, community-based, research program, addresses the key
components of translational research and can be used as a model for prevention of chronic
diseases in other low- and middle-income country settings.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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