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

Conditions

• Depression
• Obesity

Eligibility Criteria

Sex

ALL

Age

50 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• vCare Intervention (6-month active treatment followed by 6-month maintenance) — BEHAVIORAL
  During the active treatment, participants will interact with the Lumen virtual coach (for depression management) and watch the GLB videos (for weight loss). Using the Amazon Alexa app on their study iPads, participants will complete 4 weekly Lumen PST sessions initially, 2 bi-weekly sessions, and then 3 monthly sessions during the active intervention. Beginning in week 6, participants will receive automated messages with instructions to view one GLB video a week for 11 weeks. During the maintenance period, participants in the early vCare intervention arm will be able to interact with Lumen for PST coaching when they need to, i.e., "on demand," although they will receive reminders to do so at least once a month. Participants may watch any of the 12 GLB videos again and will receive GLB-themed reinforcement and motivational messages by email every 2 weeks.
• vCare Intervention (active treatment after 6 months) — BEHAVIORAL
  During the active treatment, participants will interact with the Lumen virtual coach (for depression management) and watch the GLB videos (for weight loss). Using the Amazon Alexa app on their study iPads, participants will complete 4 weekly Lumen PST sessions initially, 2 bi-weekly sessions, and then 3 monthly sessions during the active intervention. Beginning in week 6, participants will receive automated messages with instructions to view one GLB video a week for 11 weeks.

Study Details

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.

Key Dates

Start date

Jan 21, 2025

Status verified

Feb 2025

Primary completion

Apr 14, 2028

Completion

Oct 13, 2028

Study Design

Enrollment

440 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Changes in weight from baseline to 6 months [ Time Frame: From Baseline to 6 months ]

Locations (2)

Find similar trials in Chicago, IL

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