Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, 19140, United States
NCT Number: NCT02088034
The overarching goal of this project is to develop and test a behavioral intervention delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
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Notify Me20 year–75 year
Female
Interventional
Phase 4
Philadelphia, Pennsylvania, 19140, United States
The goal of the proposed research is to compare two evidence-based strategies for preventing type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC) among Latinas in a "real world" setting. The aims of this study are to 1) develop a protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic markers-hemoglobin A1C, fasting lipids, blood pressure-from baseline to 1 year between at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC) groups; and 3) understand the social and cultural context surrounding weight-related behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas assigned to PLI and metformin will have greater weight loss (primary outcome) and greater improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
Other names: ILI
Participants in this group will receive metformin 850 mg bid for one year.
Other names: Metformin
Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
Other names: Control
Time frame: 1 year
Study tests difference in body weight (Weight in kg) between treatment conditions and usual care at 12 months.
Temple University
Other
Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
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