Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
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|ClinicalTrials.gov Identifier: NCT02088034|
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : December 22, 2020
Last Update Posted : December 22, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Promotora-led Intervention Drug: Metformin Therapy Other: Usual Care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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|
- 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%)
- 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).
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
|United States, Pennsylvania|
|Temple University - Center for Obesity Research and Education|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Matthew J O'Brien, MD, MSc||Temple University|
|Responsible Party:||Temple University|
|Other Study ID Numbers:||
|First Posted:||March 14, 2014 Key Record Dates|
|Results First Posted:||December 22, 2020|
|Last Update Posted:||December 22, 2020|
|Last Verified:||November 2020|
Glucose Metabolism Disorders
Endocrine System Diseases
Body Weight Changes
Physiological Effects of Drugs