Actively Recruiting
Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older
Led by University of Illinois at Chicago · Updated on 2025-02-27
440
Participants Needed
2
Research Sites
194 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50-74 years (inclusive)
- Confirmed body mass index (BMI) between 27.0 and less than 45.0 based on weight and height measured by study staff
- Confirmed weight 396 lbs or less
- Patient Health Questionnaire-9 (PHQ-9) score between 10 and less than 20, indicating moderate to moderately severe depression
- 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 will not qualify if you...
- Unable to speak, read, or 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, recent cancer diagnosis or treatment (except non-melanoma skin cancer), end-stage organ failure, living in long-term care, or life expectancy less than 24 months
- Weight change greater than 15 lbs in the past 3 months
- Current active weight loss treatment or participation in conflicting behavioral, medical, or surgical studies
- Regular use of prescription medications that affect appetite or weight
- Planned or prior bariatric surgery within the past 2 years
- Positive screen for bulimia nervosa
- Unable to pass physical activity readiness screening or lack physician clearance
- Active suicidal thoughts with plan or intent
- Bipolar or psychotic disorder or current treatment for psychiatric conditions
- Cognitive impairment based on screening
- Active alcohol or substance use disorder
- Current or planned pregnancy or breastfeeding less than 6 months postpartum
- Family member of enrolled participant or study team member
- Investigator discretion for safety or protocol adherence reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Medicine, Vitoux Program on Aging and Prevention
Chicago, Illinois, United States, 60608
Actively Recruiting
2
Washington University School of Medicine in St Louis
St Louis, Missouri, United States, 63110
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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