Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 74
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Department of Medicine, Vitoux Program on Aging and Prevention
RECRUITING
Chicago
Missouri
Washington University School of Medicine in St Louis
NOT_YET_RECRUITING
St Louis
Time Frame
Start Date: 2025-01-21
Estimated Completion Date: 2028-10-13
Participants
Target number of participants: 440
Treatments
Experimental: Early VCare Intervention (6-month active treatment followed by 6-month maintenance)
Participants randomized to the early-intervention arm will receive active treatment for 6 months, followed by maintenance for another 6 months.
Active_comparator: Later Waitlist VCare Intervention (active treatment after 6 months)
Participants in the later-intervention arm will be waitlisted for 6 months and then receive active treatment in the second 6 months.
Related Therapeutic Areas
Sponsors
Collaborators: Washington University School of Medicine, National Institute on Aging (NIA)
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov