RecruitingNot ApplicableNCT06636058

Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older

Digital InteGrated Behavioral TreatmeNt for Comorbid ObesITy and DeprEssion Among Racial and Ethnic Adults Age 50 and Older (IGNITE)


Sponsor

University of Illinois at Chicago

Enrollment

440 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study, called IGNITE, is testing a combined digital treatment program targeting both obesity and depression simultaneously in racially and ethnically diverse adults aged 50–74. The program uses a digital app and wearable device to deliver behavioral support for weight loss and mood improvement. The study is designed specifically for non-white adults, as these groups are disproportionately affected by both conditions. **You may be eligible if...** - You are between 50 and 74 years old - Your BMI is between 27 and 45 kg/m² and you weigh 396 lbs or less - You have moderate-to-moderately severe depressive symptoms (PHQ-9 score between 10 and 19) - You self-identify as a racial or ethnic minority (not non-Hispanic White) - You have reliable home Wi-Fi - You are willing to be randomized to a study group and provide e-consent **You may NOT be eligible if...** - You have type 1 or type 2 diabetes, heart disease, stroke, or active cancer - You have gained or lost more than 15 lbs in the past 3 months - You are currently in another formal weight loss program - You take medications affecting appetite or weight (anti-obesity drugs, oral steroids, oral diabetes medications) - You have had or are planning bariatric surgery (unless it was more than 2 years ago) - You have bipolar disorder, psychosis, or are currently in individual therapy for depression - You have active suicidal thoughts - You are pregnant, nursing, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALvCare Intervention (6-month active treatment followed by 6-month maintenance)

During the active treatment, participants will interact with the Lumen virtual coach (for depression management) and watch the GLB videos (for weight loss). Using the Amazon Alexa app on their study iPads, participants will complete 4 weekly Lumen PST sessions initially, 2 bi-weekly sessions, and then 3 monthly sessions during the active intervention. Beginning in week 6, participants will receive automated messages with instructions to view one GLB video a week for 11 weeks. During the maintenance period, participants in the early vCare intervention arm will be able to interact with Lumen for PST coaching when they need to, i.e., "on demand," although they will receive reminders to do so at least once a month. Participants may watch any of the 12 GLB videos again and will receive GLB-themed reinforcement and motivational messages by email every 2 weeks.

BEHAVIORALvCare Intervention (active treatment after 6 months)

During the active treatment, participants will interact with the Lumen virtual coach (for depression management) and watch the GLB videos (for weight loss). Using the Amazon Alexa app on their study iPads, participants will complete 4 weekly Lumen PST sessions initially, 2 bi-weekly sessions, and then 3 monthly sessions during the active intervention. Beginning in week 6, participants will receive automated messages with instructions to view one GLB video a week for 11 weeks.


Locations(2)

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

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NCT06636058


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