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.
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
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
University of Illinois at Chicago
Lead sponsor
Washington University School of Medicine
Collaborator
National Institute on Aging (NIA)
Collaborator