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

NCT06636058 | Recruiting DMC

• 2 other identifiers: 2024-0908R01AG084527
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Changes in weight from baseline to 6 months

  All participants will receive a study-provided wireless weight scale (Withings Body - Digital Wi-Fi Smart Scale), assistance with account and device setup, and as-needed tech support. A study coordinator who is blinded to randomization will proactively contact participants by phone, email, and/or text to remind them to weigh themselves in the morning after urination (and a bowel movement too, if able to do so) on 3 days during the assessment week at baseline (0), 6, 12 months. Participants will be instructed to self-weigh in a T-shirt and undergarment and with no socks or shoes using their study-provided digital scale. We will obtain participants' self-monitored weight data using a developed program for automated daily synchronization via the Fitbit open API.

  From Baseline to 6 months

• Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months

  The SCL-20 is a valid, reliable measure of depression severity. It has been used in numerous depression treatment trials in primary care and community settings, making it particularly useful for cross-study comparisons and data synthesis in meta-analyses. The SCL-20 had good internal consistency (Cronbach's alpha=0.859) and correlated well with the General Health Questionnaire (r=0.78), a psychiatric screening test.

  From Baseline to 6 months

Secondary Outcomes (19)

• Changes in weight from baseline to 12 months

  From Baseline to 12 months

• Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 12 months

  From Baseline to 12 months

• Clinically significant weight change from baseline

  From baseline to 6 months, 12 months

• Depression Response

  From baseline to 6 months, 12 months

• Depression Remission

  Baseline, 6 months, 12 months

Study Arms (2)

Early VCare Intervention (6-month active treatment followed by 6-month maintenance)

EXPERIMENTAL

Participants randomized to the early-intervention arm will receive active treatment for 6 months, followed by maintenance for another 6 months.

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

Later Waitlist VCare Intervention (active treatment after 6 months)

ACTIVE COMPARATOR

Participants in the later-intervention arm will be waitlisted for 6 months and then receive active treatment in the second 6 months.

Behavioral: vCare Intervention (active treatment after 6 months)

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.

Early VCare Intervention (6-month active treatment followed by 6-month maintenance)

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.

Later Waitlist VCare Intervention (active treatment after 6 months)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Washington University School of Medicine: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Department of Medicine, Vitoux Program on Aging and Prevention

Chicago, Illinois, 60608, United States

RECRUITING

Washington University School of Medicine in St Louis

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Depression

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator, Beth and George Vitoux Professor of Medicine Affiliation: University of Illinois at Chicago

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): April 14, 2028
• Study Completion (Estimated): October 13, 2028
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

US (2)