Can a virtual coach tackle both obesity and depression?
NCT ID NCT06636058
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial tests a fully digital program that combines a virtual coach for depression with a video-based weight loss plan. It aims to help racial and ethnic adults aged 50 and older who have both obesity and depression. Participants are randomly assigned to start the program immediately or after a wait period, and their weight and mood are tracked over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A digital behavioral intervention combining a virtual coach for depression (Lumen) and a video-based weight loss program (GLB)
- What this could lead to
- If effective, this could offer a scalable, accessible way to manage both obesity and depression together in older minority adults.
- What could go wrong
- The trial is early and results may not apply to everyone. Success depends on participants engaging with the digital tools, and some may find them less effective than in-person care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 440 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Medicine, Vitoux Program on Aging and Prevention
RECRUITINGChicago, Illinois, 60608, United States
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Washington University School of Medicine in St Louis
NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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