A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India

NACompletedINTERVENTIONAL
Enrollment

599

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Diabetes Mellitus, Type 2
Interventions
BEHAVIORAL

Lifestyle Intervention

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.

BEHAVIORAL

Standard of Care

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.

Trial Locations (1)

600 086

Madras Diabetes Research Foundation, Chennai

Sponsors
All Listed Sponsors
collaborator

Madras Diabetes Research Foundation

OTHER

lead

Emory University

OTHER