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

NCT ID: NCT06636058

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2028-10-13

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.

Detailed Description

The objective of this project is to test the efficacy of a fully digital intervention, combining the Lumen problem-solving treatment (PST) virtual coach for depression management with the Diabetes Prevention Program (DPP) video-based program for weight loss. This integrated intervention is named vCare. Patients self-identified as a racial or ethnic minority with depression and obesity will be enrolled from a large minority-serving academic medical center in Chicago.

In this fully remote clinical trial, participants will receive a study iPad, a wireless weight scale, and a wearable activity tracker. Eligible participants who complete baseline assessment (N=440) will be randomly assigned in 1:1 ratio to receive the vCare intervention early (for 6 months of active treatment and 6 months of maintenance) or later (for 6 months waitlist control and 6 months of active treatment). Participants in either the early- or later-intervention arm will be assessed at 6 and 12 months follow-up.

The specific aims of this study are to (1) determine the intervention efficacy to improve the primary depressive symptoms and weight loss outcomes and secondary outcomes (e.g., anxiety, sleep, quality of life, social isolation, loneliness, and psychosocial and cognitive functioning) at 6 months; (2) identify predictors of treatment success, defined by clinically significant weight loss (5%) and depression response (50% symptom reduction) or remission (free of symptoms), at 6 and 12 months; and (3) characterize the experiences and perceptions of intervention participants to inform future adaptation and translation.

Conditions

Obesity; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

vCare Intervention (active treatment after 6 months)

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Jun Ma

MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine Affiliation: University of Illinois at Chicago

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Medicine, Vitoux Program on Aging and Prevention

Chicago, Illinois, United States

Site Status: RECRUITING

Washington University School of Medicine in St Louis

St Louis, Missouri, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Facility Contacts

Jun Ma, MD, PhD

Role: primary

maj2015@uic.edu

312-413-9830

Leslie Sandoval, BS

Role: backup

lsando8@uic.edu

6307101940

Thomas Kannampallil, PhD

Role: primary

thomas.k@wustl.edu

314-273-7801

Other Identifiers

R01AG084527

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024-0908

Identifier Type: -

Identifier Source: org_study_id