vCare Intervention (active treatment after 6 months) / Obesity / Depression · Interventional Study

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

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective randomized controlled trial of a fully digital integrated behavioral intervention combining depression and weight loss management in older racial and ethnic minorities with comorbid obesity and depression. The study is currently recruiting and has not yet posted results; efficacy outcomes at 6 and 12 months are planned but not yet reported.

What was studied

Interventional, Randomized, Parallel, Double masking, Treatment purpose. Obesity, Depression; age from 50 Years; to 74 Years. Intervention: Early VCare Intervention (6-month active treatment followed…. Compared with: Later Waitlist VCare Intervention (active treatment after 6… — Active Comparator. n = 440. 2 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Results are not yet available in this registry record. When completed, this trial will provide evidence on the efficacy of an integrated digital intervention for a common and understudied comorbidity in an underrepresented population.

Plain-language summary

This is a clinical trial registry record describing a planned interventional study with no results posted; the study is actively recruiting and has not yet reported outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Changes in weight from baseline to 6 months (assessed at From Baseline to 6 months); Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months (assessed at From Baseline to 6 months)

DesignInterventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationObesity, Depression; age from 50 Years; to 74 Years

Sample size440

InterventionEarly VCare Intervention (6-month active treatment followed…

ComparatorLater Waitlist VCare Intervention (active treatment after 6… — Active Comparator

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment440

Primary outcome measure 1Changes in weight from baseline to 6 months

Primary outcome measure 2Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months

Secondary outcome: clinically significant weight loss threshold5%

Secondary outcome: depression response threshold50% decline or SCL-20 < 0.5

Clinical bottom line

Caveats

No results posted; outcomes are planned measures only.
No information on blinding, allocation concealment, or other methodological details to assess risk of bias.
No data on recruitment progress, retention rates, or any interim findings.
Study phase listed as 'NA'; treatment modality and duration described but not formally phase-designated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized controlled trial with two arms and defined primary outcomes.

Directness

strong

Addresses clinically relevant comorbidity in target population with behavioral intervention.

Consistency

insufficient

Registry record only; no results available for consistency assessment.

Risk of bias

insufficient

No methods detail on blinding, allocation concealment, or completion rates available.

Sample adequacy

moderate

440 participants estimated; planned enrollment appears adequate for primary outcomes.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06636058). This is a study registration, not published results. Lead sponsor: University of Illinois at Chicago. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 440 participants (ESTIMATED). Conditions: Obesity, Depression. Interventions: BEHAVIORAL: vCare Intervention (6-month active treatment followed by 6-month maintenance); BEHAVIORAL: vCare Intervention (active treatment after 6 months). Primary outcome measures: Changes in weight from baseline to 6 months , From Baseline to 6 months; Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months , From Baseline to 6 months. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

vCare Intervention (active treatment after 6 months)ObesityUniversity of Illinois at ChicagoDepressionNCT06636058vCare Intervention (6-month active treatment followed by 6-month maintenance)