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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088034
• Other study ID #: 21273
• Status: Completed
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: November 2020
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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, ß-blockers, and systemic glucocorticoids).

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Temple University - Center for Obesity Research and Education	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Study tests difference in body weight (Weight in kg) between treatment conditions and usual care at 12 months.	1 year