Recruiting

Digital Integrated Behavioral TreatmentDigital InteGrated Behavioral treatmeNt for Comorbid obesITy and deprEssion Among Racial and Ethnic Adults Age 50 and Older

Sponsor:

University of Illinois at Chicago

Code:

NCT06636058

Conditions

Obesity

Depression

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

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

vCare Intervention (active treatment after 6 months)

Study Details

Brief 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

Study ID

NCT06636058

Start date

Jan 21, 2025

Status verified date

Aug, 2026

Completion date

Oct 13, 2028

Anticipated

Primary completion date

Apr 14, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

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

Exclusion Criteria

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
Current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS), other programs led by trained personnel (professional or lay) at the recruiting clinic or in the local community
Taking prescription medications regularly that affect appetite/weight (e.g., anti-obesity medicines, oral corticosteroids, oral hypoglycemics, etc.) for chronic disease management
Planned or prior bariatric surgery (Note: patients who are more than 2 years post bariatric surgery may otherwise be eligible)
Screen positive for bulimia nervosa using PHQ- eating disorder module
Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician clearance to participate
Active suicidal ideation (PHQ-9 item 9 score ≥1 or SCL-20 item 2 score ≥2) with active plan and/or intent
Bipolar or psychotic disorder, or pharmacotherapy or psychotherapy (individual or professionally-led group therapy), or brain stimulation therapy for depression or any other psychiatric condition
Cognitive impairment based on the Callahan 6-item screener
Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)
Current or planned pregnancy or lactating (<6 months postpartum)
Participation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss and depression outcomes of this study
Family/household member of an already enrolled participant or of a study team member
Investigator discretion for serious safety or protocol adherence reasons

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

vCare Intervention (active treatment after 6 months)

Primary outcome measure

Changes in weight from baseline to 6 months [ Time Frame: From Baseline to 6 months ]
Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months [ Time Frame: From Baseline to 6 months ]

Central Contacts and Locations

Locations

Department of Medicine, Vitoux Program on Aging and Prevention

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Jun Ma, MD, PhD

312-413-9830 maj2015@uic.edu

Leslie Sandoval, BS

6307101940 lsando8@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-08-18.