Digital Therapy for Obesity and Depression
(IGNITE Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that participants not take prescription medications that affect appetite or weight, such as anti-obesity medicines or oral corticosteroids. If you are taking such medications, you may need to stop them to participate in the trial.
What data supports the effectiveness of the treatment vCare Intervention for obesity and depression?
Research shows that digital health interventions can help with weight loss in underserved populations and improve depressive symptoms in people with obesity. Additionally, a study on a similar program, I-CARE, found that integrating behavioral therapy for mood and weight management can lead to improvements in both weight and depression severity.12345
Is the digital therapy for obesity and depression safe for humans?
What makes the vCare Intervention treatment unique for obesity and depression?
The vCare Intervention is unique because it uses digital technology to enhance traditional cognitive behavioral therapy (CBT) for obesity and depression, potentially overcoming barriers like time, cost, and distance. It incorporates features like virtual reality and smartphone apps with 3D food picture recognition to improve eating behaviors and mood, which are less commonly addressed in other treatments.2571011
Eligibility Criteria
This trial is for adults aged 50 and older who belong to racial and ethnic minority groups, have both obesity and depression, but no other major health issues. Participants must be willing to use digital tools for treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Early VCare Intervention
Participants receive active treatment for 6 months, followed by 6 months of maintenance
Later Waitlist VCare Intervention
Participants are waitlisted for 6 months, then receive active treatment for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- vCare Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
Washington University School of Medicine
Collaborator
National Institute on Aging (NIA)
Collaborator