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

NCT02088034 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2020-12-22

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Temple University

    lead OTHER

Principal Investigators

  • Matthew J O'Brien, MD, MSc · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088034 on ClinicalTrials.gov