NCT02088034

Intervention to Promote Weight Loss in Latinas At-risk for Diabetes

Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Promotora-led Intervention	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.
DRUG	Metformin Therapy	Participants in this group will receive metformin 850 mg bid for one year.
OTHER	Usual Care	Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-03-14
• Last updated: 2020-12-22
• Results posted: 2020-12-22

Locations

1 site across 1 country: United States