Status:
COMPLETED
Promotora-Led Intervention for Metabolic and Mental Health
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
PreDiabetes
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evidence-based programs to prevent diabetes among high-risk individuals are less effective among those who also have mental health needs. This study involves developing and pilot testing the first ada...
Detailed Description
The overall goal of this study is to develop an effective and potentially scalable intervention to prevent diabetes in people with elevated mental health symptoms (EMS) and prediabetes. This study foc...
Eligibility Criteria
Inclusion
- Latino ethnicity
- Spanish fluency
- Age ≥18 years
- BMI ≥25 kg/m2
- And "increased risk of diabetes" (ADA Diabetes Risk Score ≥5 as determined by 7-item questionnaire and/or hemoglobin A1C ≥ 5.7%)
Exclusion
- 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).
Key Trial Info
Start Date :
August 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2019
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03372018
Start Date
August 7 2018
End Date
March 22 2019
Last Update
June 5 2019
Active Locations (1)
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1
Northwestern Univeristy
Chicago, Illinois, United States, 60611