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Digital Intervention for Obesity and Depression in Adults 50 and Older

This study is testing a digital program called vCare for adults aged 50-74 who have both obesity and depression. The vCare program combines a virtual coach (Lumen) to help with depression and videos (GLB videos) for weight loss. You would use a study iPad with the Amazon Alexa app to access these tools. Researchers want to see if vCare helps people lose weight and improve their depression symptoms after 6 months. To join, you need to be 50-74 years old, have a body mass index (BMI) between 27.0 and 45.0, weigh less than 396 lbs, and have moderate to moderately severe depressive symptoms. The study is currently unclear about its status and plans to enroll 440 participants.

Study design
This is a randomized clinical trial where 440 participants will be assigned by chance to receive the vCare intervention early or later. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Participants will interact with the Lumen virtual coach and watch GLB videos. You will complete 4 weekly Lumen PST sessions initially, then 2 bi-weekly sessions. You will also receive a study iPad, a wireless weight scale, and a wearable activity tracker.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at 6 and 12 months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06636058

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

Recruiting
NAAges 50–74InterventionalTreatment
University of Illinois at Chicago
~440 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:vCare Intervention (6-month active treatment followed by 6-month maintenance)vCare Intervention (active treatment after 6 months)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in weight from baseline to 6 months
Measured over From Baseline to 6 months
+1 more outcome measured

Conditions

Obesity
Depression

Explore related trials

DepressionObesity

Where it's being run

2 sites across 2 states
Illinois1
Missouri1

Who to contact

Jun Ma, MD, PhD
[email protected]
312-413-9830
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Changes in weight from baseline to 6 monthsFrom 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.

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