A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lifestyle Intervention; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention arm participants will attend 6 months of weekly classes where they will be taught the skills necessary to reach these goals. The curriculum for the classes is based on the DPP lesson plans. Social support will be provided by trained lay health educators and peer support groups. Participants who remain at highest risk of T2DM after four or more months in the program will be prescribed metformin in addition to continuing the lifestyle program. Metformin dosages will start at 500 mg per day, and, when appropriate, will increase to 1000 mg per day (given as 500 mg twice per day). This group will be comprised of individuals who have (1) Fasting plasma glucose values of 100 mg/dl or more and (2) elevated fasting HbA1c measures of 5.7% or more.; Participants randomized to the standard of care group will meet with a physician and a dietician, attend one class/awareness lecture on diabetes prevention through weight loss and diet change and one class on exercise, and receive handouts reinforcing what they learn in class and with the dietician, fitness consultant, and physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes Mellitus, Type 2; India; Prevention & Control; Lifestyle Intervention; Translational Research