Skip to main content
OpenTrials
Completed

NCT Number: NCT02088034

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Temple University - Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Promotora-led Intervention

Behavioral

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

Metformin Therapy

Drug

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

Other names: Metformin

Usual Care

Other

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

Other names: Control

Primary outcomes

  1. Body Weight

    Time frame: 1 year

    Study tests difference in body weight (Weight in kg) between treatment conditions and usual care at 12 months.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2014
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.