Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older
Eligible age
50–74 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
The goal of this randomized clinical trial is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving therapy virtual coach for depression management with the Diabetes Prevention Program video-based program for weight loss, among racial and ethnic minorities with comorbid depression and obesity. The study aims include: * Determine the efficacy of the vCare intervention at 6 months. Primary outcomes are weight and depression symptom checklist 20-item (SCL-20) score. * Identify predictors of treatment success, defined by achieving clinically significant weight loss (5%) and depression outcomes (50% decline or SCL-20\<0.5), at 6 and 12 months. * Characterize participant experiences and perceptions of the vCare intervention. Eligible participants will be randomized to the early-intervention arm who will receive active treatment for 6 months, followed by maintenance for another 6 months, or the later-intervention arm who will be waitlisted for 6 months and then receive active treatment in the second 6 months.
Sponsor: University of Illinois at Chicago
You may qualify if…
- ✓ Age 50-74 years (inclusive)
- ✓ Confirmed body mass index (BMI) between ≥27.0 and \<45.0 based on weight and height measured by study staff at device distribution
- ✓ Confirmed weight ≤396 lbs
- ✓ Patient Health Questionnaire-9 (PHQ-9) scores between ≥10 and \<20, indicating moderate to moderately severe depressive symptoms
- ✓ Self-identified race and ethnicity other than non-Hispanic White
- ✓ Willing and able to accept randomization, and provide informed e-consent and HIPAA authorization
You may not qualify if…
- ✕ Unable to speak, read, understand English sufficiently for informed consent
- ✕ No reliable Wi-Fi Internet access at home
- ✕ Pre-existing type 1 or type 2 diabetes, coronary heart disease, heart failure, stroke, cancer diagnosis (other than non-melanoma skin cancer) or treatment in the past 12 months, end-stage organ failure, residence in a long-term care facility, life expectancy \<24 months
- ✕ Self-report of weight change \>15 lbs. during prior 3 months
- ✕ Current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS), other programs led by trained personnel (professional or lay) at the recruiting clinic or in the local community
- ✕ Taking prescription medications regularly that affect appetite/weight (e.g., anti-obesity medicines, oral corticosteroids, oral hypoglycemics, etc.) for chronic disease management
- ✕ Planned or prior bariatric surgery (Note: patients who are more than 2 years post bariatric surgery may otherwise be eligible)
- ✕ Screen positive for bulimia nervosa using PHQ- eating disorder module
Where it's recruiting
Source: ClinicalTrials.gov · NCT06636058 · last updated 2025-02-27