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

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.

Conditions

• Obesity
• Depression

Interventions

BEHAVIORAL

vCare Intervention (6-month active treatment followed by 6-month maintenance)

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.

BEHAVIORAL

vCare Intervention (active treatment after 6 months)

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.

Sponsors & Collaborators

• Washington University School of Medicine

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• University of Illinois at Chicago

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-21

Primary Completion

2028-04-14

Completion

2028-10-13

Countries

• United States

Study Locations