Digital InteGrated Behavioral treatmeNt for Comorbid obesITy and deprEssion Among Racial and Ethnic Adults Age 50 and Older
Recruiting · NCT06636058 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
2 locations listed across 2 US states.
- Department of Medicine, Vitoux Program on Aging and Prevention - Chicago, Illinois, United States
- Washington University School of Medicine in St Louis - St Louis, Missouri, United States