Digital intervention for obesity and depression in older racial and ethnic adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial tests a fully digital intervention called vCare, which combines a virtual coach for depression management with a video-based program for weight loss. Participants aged 50 and older, who self-identify as racial or ethnic minorities and have comorbid obesity and depression, will be randomly assigned to receive either immediate or delayed access to the intervention. The study aims to evaluate the efficacy of vCare in improving weight and depression symptoms over a 12-month period, while also identifying predictors of treatment success and characterizing participant experiences. Participants will receive a study iPad, a wireless weight scale, and a wearable activity tracker to facilitate their engagement in the program.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Medicine, Vitoux Program on Aging and Prevention
  Chicago, Illinois, United States Recruiting
• Washington University School of Medicine in St Louis
  St Louis, Missouri, United States Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.