Digital Therapy for Obesity and Depression

(IGNITE Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Anti-obesity, Corticosteroids, Hypoglycemics, others

Disqualifiers: Diabetes, Heart disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program designed to aid in weight loss and depression management. The program, called the vCare Intervention, combines a virtual coach for depression management with a video-based weight loss program. It targets individuals who identify as racial or ethnic minorities and experience both obesity and moderate to moderately severe depression. Participants are divided into two groups: one begins the program immediately, while the other starts after six months. Individuals with a BMI between 27.0 and 45.0, moderate depression, and not currently enrolled in any weight loss program may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore a new approach to managing weight and depression simultaneously.

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 prior data suggests that this digital intervention is safe for managing obesity and depression?

Research shows that digital therapies, such as the vCare Intervention for obesity and depression, are generally easy to use and safe. Although specific safety data for this intervention is not yet available, similar digital health tools have been used in other studies without major safety issues. Past research on digital methods for weight loss and mental health has demonstrated good results without serious side effects.

This trial's digital approach poses less risk than traditional medical treatments. Digital therapies typically involve apps or online programs, which are unlikely to cause harm, making them a relatively safe option for managing conditions like obesity and depression. Prospective participants should consult a healthcare provider if they have any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the vCare Intervention because it combines digital technology with personalized support to tackle both obesity and depression. Unlike traditional treatments that often focus on just one condition at a time, vCare aims to address the interconnected nature of these health issues. By offering an early-intervention option and a waitlist-controlled approach, it provides flexibility and personalized care, potentially leading to more sustainable health outcomes. Additionally, the digital format offers greater accessibility and convenience, breaking down barriers to treatment for many individuals.

What evidence suggests that the vCare intervention could be effective for obesity and depression?

Research shows that the vCare program, which uses digital therapy focused on cognitive behavioral therapy (CBT) for obesity and depression, holds promise in treating these conditions. Studies have found that digital tools like vCare can help people make lifestyle changes that lead to weight loss and improved mood. One study noted a drop in body mass index (BMI) and fewer depression symptoms for those using similar digital health methods. In this trial, participants in the early-intervention arm will receive active treatment for 6 months, followed by maintenance for another 6 months, while those in the later-intervention arm will wait for 6 months before receiving active treatment. Additionally, the vCare app provides ongoing support and interaction, which can help sustain these positive results over time. These findings suggest that vCare could effectively help people manage obesity and depression together. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Early VCare Intervention (6-month active treatment followed by 6-month maintenance) Experimental Treatment 1 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 Control 1 Intervention

Participants in the later-intervention arm will be waitlisted for 6 months and then receive active treatment in the second 6 months.

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+

Published Research Related to This Trial

In a 16-week study involving 76 adults with a body mass index of 27 to <35 kg/m², the SmartByte™ System, combined with a lifestyle video program, helped 30% of participants achieve at least 5% weight loss, indicating its efficacy as a weight loss tool.

The study reported only mild to moderate device-related adverse events, suggesting that the SmartByte™ System is a safe option for weight management, especially with higher usage leading to better weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of an oral device to reduce food intake and promote weight loss. Ryan, DH., Parkin, CG., Longley, W., et al.[2020]

Participants with a baseline BMI of 35 or higher experienced greater reductions in weight and waist circumference with a coach-led intervention compared to usual care and self-directed interventions, indicating that more severe obesity may benefit from structured support.

For individuals with a baseline BMI between 25 and 35, the self-directed intervention was more effective than usual care, suggesting that treatment strategies should be tailored based on the severity of obesity for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care. Azar, KM., Xiao, L., Ma, J.[2021]

In a pilot study with 46 participants, an unguided online intervention for obesity and depressive symptoms showed moderate to high user acceptance, particularly in terms of usefulness and ease of learning.

Despite a high uptake rate of 76.1%, only 22.9% of participants completed the intervention, indicating that while the program is well-received, improvements are needed to enhance completion rates and overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[User Acceptance of an Online-Intervention for Improving Depressive Symptoms in Adults with Obesity - Results of a Pilot Study]. Löbner, M., Stein, J., Rechenberg, T., et al.[2022]

A 12-month randomized controlled trial will test a digital weight gain prevention intervention for patients with obesity, focusing on tailored behavior change and remote coaching, compared to usual care.

The primary goal is to prevent weight gain (defined as ≤3% change in baseline weight) in a diverse group of medically vulnerable patients, highlighting the potential of digital health solutions in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care. Berger, MB., Steinberg, DM., Askew, S., et al.[2021]

A survey of 152 participants with obesity revealed that face-to-face communication with therapists is highly valued, indicating that traditional methods remain crucial in treatment despite the potential for technology-based interventions.

Participants showed a neutral attitude towards the use of virtual reality (VR) in obesity treatment, with low familiarity but some openness to its application for body image exercises, suggesting a need for further education and research on integrating VR into therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital communication and virtual reality for extending the behavioural treatment of obesity - the patients' perspective: results of an online survey in Germany. Luck-Sikorski, C., Hochrein, R., Döllinger, N., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Digital technology can be effectively used for behavioral weight control, particularly through self-monitoring of weight-related behaviors, making it a promising tool for promoting healthy eating and physical activity habits.

Technology-based interventions offer a cost-effective alternative to traditional face-to-face treatments, allowing for broader reach and accessibility to individuals seeking to manage their weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of innovations in digital health technology to promote weight control. Thomas, JG., Bond, DS.[2021]

This systematic review aims to evaluate the effectiveness of internet-based and mobile-based interventions (IMIs) for adults with overweight or obesity who also experience depressive symptoms, highlighting their potential as low-cost and accessible treatment options.

The review will include randomized controlled trials (RCTs) and will follow rigorous standards for data extraction and quality assessment, ensuring a comprehensive analysis of the evidence regarding IMIs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based and mobile-based interventions for adults with overweight or obesity experiencing symptoms of depression: a systematic review protocol. Schladitz, K., Luppa, M., Riedel-Heller, SG., et al.[2023]

The pilot study involving 20 adults aged 30-60 demonstrated that using the CogniNU app led to significant weight reduction and improved mindful eating behaviors, particularly in the control-first group after app use.

While the intervention-first group showed a decrease in fat percentage during the initial app use, it increased in the second period, indicating the need for further research on the long-term effectiveness of technology-based weight control interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a novel telehealth device for dietary cognitive behavioral intervention in overweight or obesity care. Fang, YY., Lee, JI., Wu, NY., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment. McVay, M., Steinberg, D., Askew, S., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-obesity-2025-0f66c

Digital Therapy for Obesity and Depression (IGNITE Trial) The vCare Intervention is unique because it uses digital technology to enhance traditional cognitive behavioral therapy (CBT) for obesity and depression, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37463558/

V-care: An application to support lifestyle improvement in ... The purpose of this article is to introduce the V-care app, a mobile health platform specifically developed to offer effective interaction and support young ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1386505623001582

V-care: An application to support lifestyle improvement in ... The V-care is an health mobile application specifically developed to offer effective interaction and support young people in a long-term obesity treatment ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7089815/

Effect of an Intervention for Obesity and Depression ... The results showed that this integrated collaborative care intervention improved patient-centered outcomes in addition to the previously documented improvements ...

5. researchgate.net researchgate.net/publication/366654389_Effectiveness_of_a_Scalable_mHealth_Intervention_for_Children_with_Overweight_and_Obesity

Effectiveness of a Scalable mHealth Intervention for ... Youth experienced a 0.70 U decrease in BMI [standard deviation (SD) = 2.19] and a 4.45% decrease (SD = 8.5) in %BMIp95 over a mean of 31.5 weeks. The overall ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4885789/

Track: A randomized controlled trial of a digital health obesity ... Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings. Methods. Track is a 12-month randomized ...

7. researchprotocols.org researchprotocols.org/2022/2/e32240/

Digital Interventions to Reduce Distress Among Health ... This project aims to demonstrate the feasibility of using digital platforms to understand the continuum of moral distress that can lead to moral injury.

8. trial.medpath.com trial.medpath.com/clinical-trial/e61eb25bb9bb73d2/nct06636058-integrated-behavioral-treatment-obesity-depression

Digital InteGrated Behavioral TreatmeNt for Comorbid ... The study aims include: * Determine the efficacy of the vCare intervention at 6 months. Primary outcomes are weight and depression symptom checklist 20-item ( ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10482795/

The Effectiveness of eHealth Interventions for Weight Loss ... All studies showed a statistically significant weight loss after the digital health intervention. Seven studies reported a significant difference between ...