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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088034
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Promotora-led Intervention Drug: Metformin Therapy Other: Usual Care Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Study Start Date : September 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Promotora-led Intervention
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
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 Name: ILI

Active Comparator: Usual care
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
Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
Other Name: Control

Active Comparator: Metformin Therapy
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
Participants in this group will receive metformin 850 mg bid for one year.
Other Name: Metformin




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088034


Locations
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United States, Pennsylvania
Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Matthew J O'Brien, MD, MSc Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02088034    
Other Study ID Numbers: 21273
First Posted: March 14, 2014    Key Record Dates
Results First Posted: December 22, 2020
Last Update Posted: December 22, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs