440 Participants Needed

Digital Therapy for Obesity and Depression

(IGNITE Trial)

Recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants not take prescription medications that affect appetite or weight, such as anti-obesity medicines or oral corticosteroids. If you are taking such medications, you may need to stop them to participate in the trial.

What data supports the effectiveness of the treatment vCare Intervention for obesity and depression?

Research shows that digital health interventions can help with weight loss in underserved populations and improve depressive symptoms in people with obesity. Additionally, a study on a similar program, I-CARE, found that integrating behavioral therapy for mood and weight management can lead to improvements in both weight and depression severity.12345

Is the digital therapy for obesity and depression safe for humans?

The research articles reviewed do not provide specific safety data for the digital therapy for obesity and depression, including the vCare Intervention.36789

What makes the vCare Intervention treatment unique for obesity and depression?

The vCare Intervention is unique because it uses digital technology to enhance traditional cognitive behavioral therapy (CBT) for obesity and depression, potentially overcoming barriers like time, cost, and distance. It incorporates features like virtual reality and smartphone apps with 3D food picture recognition to improve eating behaviors and mood, which are less commonly addressed in other treatments.2571011

Eligibility Criteria

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.

Inclusion Criteria

Self-identified race and ethnicity other than non-Hispanic White
Confirmed body mass index (BMI) between ≥27.0 and <45.0 based on weight and height measured by study staff at device distribution
Patient Health Questionnaire-9 (PHQ-9) scores between ≥10 and <20, indicating moderate to moderately severe depressive symptoms
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Exclusion Criteria

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
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early VCare Intervention

Participants receive active treatment for 6 months, followed by 6 months of maintenance

12 months
Remote monitoring with digital tools

Later Waitlist VCare Intervention

Participants are waitlisted for 6 months, then receive active treatment for 6 months

12 months
Remote monitoring with digital tools

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • vCare Intervention
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

The RAINBOW trial will evaluate the effectiveness of the Integrated Coaching for Better Mood and Weight (I-CARE) program, which combines behavioral therapy for depression and obesity, in 404 obese and depressed adults over 12 months.
The study aims to show that participants in the I-CARE program will experience greater improvements in both weight and depression severity compared to those receiving usual care, with follow-up assessments extending to 24 months to measure sustained effects.
Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial.Ma, J., Yank, V., Lv, N., et al.[2021]
A review of literature found that while there are mobile apps designed for managing either overweight/obesity or depression/anxiety, none specifically target the simultaneous management of both conditions, despite their common overlap.
The majority of the identified studies utilized cognitive behavioral frameworks and highlighted the need for integrated mobile health solutions to address the comorbidity of overweight/obesity and mental health issues, which could improve accessibility and reduce treatment costs.
Mobile Apps for the Management of Comorbid Overweight/Obesity and Depression/Anxiety: A Systematic Review.Gómez-de-Regil, L., Avila-Nava, A., Gutierrez-Solis, AL., et al.[2021]
In a study involving 134-141 community health center patients with obesity, specific documentation of intervention-focused weight counseling by providers led to an average weight loss of 3.1 kg compared to general counseling, highlighting the importance of targeted support in weight loss interventions.
Participants who felt their providers showed empathy lost more weight over 6 to 12 months, suggesting that the emotional connection in counseling can significantly enhance weight loss outcomes.
Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment.McVay, M., Steinberg, D., Askew, S., et al.[2020]

References

Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. [2021]
Mobile Apps for the Management of Comorbid Overweight/Obesity and Depression/Anxiety: A Systematic Review. [2021]
Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment. [2020]
[User Acceptance of an Online-Intervention for Improving Depressive Symptoms in Adults with Obesity - Results of a Pilot Study]. [2022]
Effect of a novel telehealth device for dietary cognitive behavioral intervention in overweight or obesity care. [2023]
Efficacy and safety of an oral device to reduce food intake and promote weight loss. [2020]
Review of innovations in digital health technology to promote weight control. [2021]
Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care. [2021]
The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care. [2021]
Digital communication and virtual reality for extending the behavioural treatment of obesity - the patients' perspective: results of an online survey in Germany. [2023]
Effectiveness of internet-based and mobile-based interventions for adults with overweight or obesity experiencing symptoms of depression: a systematic review protocol. [2023]