Promotora-Led Intervention for Metabolic and Mental Health
Completed · Not applicable
Conditions studied: PreDiabetes, Obesity, Metabolic Disease, Body Weight Changes, Diabetes Mellitus
In brief
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 adaptation of the landmark Diabetes Prevention Program lifestyle intervention to simultaneously treat prediabetes and elevated mental health symptoms. This project has large potential to impact public health, given that more than half of the U.S. adult population has either of these conditions, and is at risk for developing comorbid diabetes and mental illness.
Key facts
- Study ID
- NCT03372018
- Run by
- Northwestern University
- People needed
- 53
- Starts
- 2018-08-07
- Expected to finish
- 2019-03-22
- Last updated by the study team
- 2019-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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%)
You may not qualify if…
- 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).
Where it is running
- Northwestern Univeristy — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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