Overview

This trial is active, not recruiting.

Condition diabetes
Treatments prometra led intervention, metformin therapy, usual care
Phase phase 4
Sponsor Temple University
Start date September 2013
End date February 2016
Trial size 150 participants
Trial identifier NCT02088034, 21273

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The PLI consists of a core curriculum or 12 group sessions of 90 minute duration over a 12-week period and will be followed by a maintenance phase of 10 biweekly and then monthly 90-minute sessions during months 4 through 12. One promotora will lead each session in Spanish, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.
prometra 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.
(Active Comparator)
One physician visit at Puentes de Salud or Congreso Health Center to discuss healthy lifestyle behaviors that promote weight loss and diabetes prevention. During that visit, UC participants will also receive standard educational materials in Spanish from the NIDDK Weight-control Information Network covering the same topics. UC participants will receive another physician visit upon completion of 1-year follow-up to review laboratory assessments.
usual care
Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
(Experimental)
Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.
metformin therapy
Participants in this group will receive metformin 850 mg bid for one year.

Primary Outcomes

Measure
Body weight
time frame: 1 year

Secondary Outcomes

Measure
Cardiometabolic markers
time frame: 1 year
Physical activity
time frame: 1 year
Dietary intake
time frame: 1 year
Diabetes knowledge
time frame: 1 year

Eligibility Criteria

Female participants from 20 years up to 75 years old.

Inclusion Criteria: - Female gender - Latino ethnicity - Spanish fluency - Age ≥20 years - BMI ≥25 kg/m2 - And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item questionnaire and hemoglobin A1C ≥ 5.6%) Exclusion Criteria: - Hemoglobin A1C ≥ 6.5% - Current or planned pregnancy during the study period - Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease) - Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV) - Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).

Additional Information

Official title Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Principal investigator Matthew J O'Brien, MD, MSc
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Temple University.