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

NCT02088034 | Completed Phase 4 Results

• 1 other identifier: 21273
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes

Outcome Measures

Primary Outcomes (1)

• Body Weight

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

  1 year

Study Arms (3)

Promotora-led Intervention

EXPERIMENTAL

The Promotora-led Intervention 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.

Behavioral: Promotora-led Intervention

Usual care

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.

Other: Usual Care

Metformin Therapy

ACTIVE COMPARATOR

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.

Drug: Metformin Therapy

Interventions

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.

Also known as: ILI

Promotora-led Intervention

Metformin Therapy DRUG

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

Also known as: Metformin

Metformin Therapy

Usual Care OTHER

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

Also known as: Control

Usual care

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University - Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

The study was underpowered to detect a clinically meaningful weight difference between the metformin and standard care arms. This study was a community-based translation trial with fewer eligibility criteria than DPP, a less intensive screening process, and no run-in period. The study enrolled motivated study volunteers, potentially limiting the external validity of the findings among all Latinas with prediabetes.

Results Point of Contact

• Title: Matthew J. O'Brien, MD
• Organization: Northwestern University

matthew.obrien1@northwestern.edu

312-503-5046

Study Officials

• Matthew J O'Brien, MD, MSc

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 14, 2014
• Study Start: September 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: December 22, 2020
• Results First Posted: December 22, 2020

Record last verified: 2020-11

Locations

US (1)