Phase 4
N=92
Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02088034 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Body Weight — -4.0; .8; -.9 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Promotora-led Intervention (Behavioral); Metformin Therapy (Drug); Usual Care (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Temple University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight |
-4.0; .8; -.9 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT02088034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.