CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
Metformin Therapy +2 moredrug
Likely dose
Metformin Therapy 850 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02088034
NCT02088034Phase 4Completed
CompareCT.gov

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

Temple University·interventional·Posted Mar 14, 2014·Updated Dec 22, 2020

In Brief

A Phase 4 clinical trial evaluating Promotora-led Intervention, Metformin Therapy, and 1 other intervention for Diabetes. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 14, 2014
Enrollment StartSep 1, 2013
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.3 years ago

Interventions

Promotora-led Interventionbehavioral

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.

Metformin Therapydrug

Participants in this group will receive metformin 850 mg bid for one year.

Usual Careother

Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.