Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
NCT ID: NCT02088034
Last Updated: 2020-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
92 participants
INTERVENTIONAL
2013-09-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Usual Care
Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
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.
Metformin Therapy
Participants in this group will receive metformin 850 mg bid for one year.
Interventions
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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.
Metformin Therapy
Participants in this group will receive metformin 850 mg bid for one year.
Usual Care
Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
20 Years
75 Years
FEMALE
No
Sponsors
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Temple University
OTHER
Responsible Party
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Principal Investigators
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Matthew J O'Brien, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Temple University
Locations
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Temple University - Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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21273
Identifier Type: -
Identifier Source: org_study_id