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Behavioural Intervention

Digital Therapy for Obesity and Depression (IGNITE Trial)

N/A
Waitlist Available
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50-74 years (inclusive)
Confirmed weight ≤396 lbs
Must not have
Self-report of weight change >15 lbs. during prior 3 months
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a digital intervention that combines therapy for depression with a weight loss program for racial and ethnic minorities who have both depression and obesity. The study will look at the effectiveness of the intervention

Who is the study for?
This trial is for adults aged 50 and older who belong to racial and ethnic minority groups, have both obesity and depression, but no other major health issues. Participants must be willing to use digital tools for treatment.
What is being tested?
The study tests a fully digital vCare intervention that combines a virtual coach for depression with a video-based weight loss program. It measures the success of this approach over 6 months of active treatment plus maintenance or delayed start.
What are the potential side effects?
Since the interventions are behavioral treatments delivered digitally, there may not be traditional side effects like with medication; however, participants might experience discomfort or frustration using digital technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 74 years old.
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My weight is 396 lbs or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lost or gained more than 15 lbs in the last 3 months.
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I have a serious health condition like diabetes, heart disease, or another cancer.
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I am currently participating in a weight loss program.
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I am receiving treatment for a psychiatric condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 6 months
Changes in weight from baseline to 6 months
Secondary study objectives
Changes in Cognitive functioning from baseline to 6, 12 months
Changes in Depression Symptom Checklist 20-items (SCL-20) from baseline to 12 months
Changes in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 6, 12 months
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early VCare Intervention (6-month active treatment followed by 6-month maintenance)Experimental Treatment1 Intervention
Participants randomized to the early-intervention arm will receive active treatment for 6 months, followed by maintenance for another 6 months.
Group II: Later Waitlist VCare Intervention (active treatment after 6 months)Active Control1 Intervention
Participants in the later-intervention arm will be waitlisted for 6 months and then receive active treatment in the second 6 months.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,696 Total Patients Enrolled
36 Trials studying Obesity
9,866 Patients Enrolled for Obesity
Washington University School of MedicineOTHER
1,991 Previous Clinical Trials
2,295,444 Total Patients Enrolled
83 Trials studying Obesity
14,222 Patients Enrolled for Obesity
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,102 Total Patients Enrolled
47 Trials studying Obesity
13,193 Patients Enrolled for Obesity
~293 spots leftby Apr 2028
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