Digital Intervention for Binge Eating

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Drexel University

Must not be taking: Antipsychotics

Disqualifiers: Eating disorder treatment, Weight loss treatment, Severe psychopathology, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool called ChangeBite, designed to assist people with obesity who also struggle with binge eating. The study aims to evaluate the ease and effectiveness of this app-based intervention. Participants will use ChangeBite and provide feedback on its usability and their satisfaction. The trial seeks English-speaking adults with a BMI of 30 or higher who have experienced binge eating episodes at least 12 times in the past three months and own a smartphone with specific software. As a Phase 1 and Phase 2 trial, this research focuses on understanding how ChangeBite functions in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications, including Haldol, Loxitane, Mellaril, Moban, Navane, Prolixin, Serentil, Stelaxine, Trilafon, Thoraxine, Abilify, Clozaril, Geodon, Risperdal, Seroquel, and Zyprexa. If you are taking any of these, you would need to stop before participating.

What prior data suggests that this digital intervention is safe for individuals with obesity and binge eating behavior?

Research has shown that digital tools like ChangeBite might help reduce binge eating. In past studies, the number of people with severe binge eating behaviors decreased. For instance, some studies found a drop from 4% to 2% in severe cases and from 11%–14% to 5%–9% in moderate to severe cases. These results suggest that ChangeBite could help manage binge eating.

Regarding safety, ChangeBite is a digital tool, which usually means fewer physical side effects than medication. Since this study is in the early stages, it mainly examines how people use the app and whether it is easy to use. This phase doesn't provide detailed safety data yet, but it is an important step to ensure everything works well before larger studies. Overall, digital tools like ChangeBite are generally well-tolerated, with few reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

ChangeBite is unique because it delivers therapy for binge eating through a self-help digital platform, setting it apart from traditional face-to-face therapy and medication options like cognitive-behavioral therapy (CBT) and antidepressants. This digital intervention offers flexibility and convenience, allowing users to access guidance and support anytime, anywhere, which is a major advantage over scheduled therapy sessions. Researchers are excited about ChangeBite because it harnesses technology to potentially reach a wider audience, making evidence-based treatment more accessible and personalized, especially for those who might not seek or have access to conventional treatments.

What evidence suggests that this digital intervention is effective for binge eating?

Research shows that digital programs can help people with binge eating disorder (BED). Studies have found that these programs can reduce the frequency of binge eating episodes. They typically offer strategies and support to help individuals control their eating habits. In this trial, all participants will receive ChangeBite, the program under study, which aims to provide similar benefits by offering tools and resources for behavior change. Although specific data on ChangeBite is limited, research supports the effectiveness of digital programs for people with BED. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with obesity and binge eating behavior. Participants will be recruited in Philadelphia and must be willing to use the ChangeBite digital intervention, attend video call assessments, and provide weekly weight updates via photos. Individuals not meeting these requirements or unable to consent won't qualify.

Inclusion Criteria

BMI ≥30

Recurrent objective or subjective binge eating episodes (≥12 episodes in 3 months)

Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher

Exclusion Criteria

I am currently taking medication for mental health.

Have a mental handicap or currently experiencing severe psychopathology that would limit their ability to engage in study

I am currently undergoing treatment for weight loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

Participants engage with the ChangeBite digital intervention

12 weeks

Weekly self-reporting and app usage

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (virtual) at 12 and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ChangeBite

Trial Overview

The study tests the feasibility of a self-guided mobile app called ChangeBite designed for individuals with obesity and binge eating issues. It's an open-label pilot trial without randomization, involving follow-ups at 12 and 24 weeks to measure usability and satisfaction.

How Is the Trial Designed?

Group I: Self-Help Digital Intervention Experimental Treatment 1 Intervention

All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Oui Therapeutics, Inc.

Industry Sponsor

Trials

8

Recruited

730+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A qualitative usability evaluation of a new app for binge eating, involving 14 participants with binge eating symptoms, showed that the app had good usability and was well-received for its flexible content and interactivity.

Participants appreciated the app's easy-to-understand information and progress tracking, but raised concerns about its visual design and the absence of professional feedback, highlighting areas for improvement in future app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a Cognitive-Behavioral App-Based Intervention for Binge Eating and Related Psychopathology: A Qualitative Study. Linardon, J., King, T., Shatte, A., et al.[2022]

In a pilot study involving 22 adults with binge-eating disorder (BED), the combination of naltrexone and bupropion (NB) was well-tolerated, showing significant reductions in binge-eating frequency, eating-disorder psychopathology, depression, and weight during treatment, although these effects were not significantly different from placebo.

Notably, 45.5% of patients on NB achieved a 3% weight loss compared to none on placebo, indicating a potential benefit of NB for weight management in BED, but further research with a larger sample size is necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Grilo, CM., Lydecker, JA., Morgan, PT., et al.[2022]

In a pilot study involving 155 participants with binge-spectrum eating disorder, offering a choice between two digital interventions did not lead to significantly better treatment outcomes compared to random assignment.

Both groups showed improvements in binge eating behaviors and related concerns, suggesting that the effectiveness of digital interventions may not be influenced by client preferences when the programs are based on similar cognitive-behavioral principles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Participant's Choice of Different Digital Interventions on Outcomes for Binge-Spectrum Eating Disorders: A Pilot Doubly Randomized Preference Trial. Linardon, J., Shatte, A., Messer, M., et al.[2023]

The ASTrA digital self-help application, designed for individuals with various eating disorders, demonstrated excellent psychometric properties, including high validity and reliability, based on evaluations from 15 patients and 13 clinicians.

Both patients and clinicians found the application acceptable and feasible for clinical use, indicating strong potential for practical implementation in promoting motivation for change in eating disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a transdiagnostic digital interactive application for eating disorders: psychometric properties, satisfaction, and perceptions on implementation in clinical practice. Booij, L., Israël, M., Ferrari, M., et al.[2023]

A randomized trial with 600 participants showed that both broad and focused digital interventions for recurrent binge eating significantly improved eating disorder symptoms compared to a waitlist group, with effects lasting for 8 weeks.

The focused intervention, which targeted only dietary restraint, was as effective as the broad intervention in most outcomes but had higher dropout rates, suggesting that while it can be effective, it may not engage users as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A broad v. focused digital intervention for recurrent binge eating: a randomized controlled non-inferiority trial. Linardon, J., Shatte, A., McClure, Z., et al.[2023]

A randomized controlled study involving 74 women demonstrated that an Internet-guided self-help program based on cognitive behavioral therapy (CBT) significantly improved binge eating behaviors and related psychological factors over six months, with benefits maintained at a six-month follow-up.

The program was well-accepted by participants, indicating that transferring CBT techniques to an online format can effectively address binge eating disorder (BED) symptoms and improve overall eating disorder psychopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. Carrard, I., Crépin, C., Rouget, P., et al.[2022]

A targeted internet and app-based intervention focusing solely on cognitive-behavioral techniques to modify dietary restraint significantly reduced binge-eating episodes in 403 participants, most of whom reported binge eating weekly.

The intervention not only decreased binge-eating frequency but also improved various secondary outcomes related to eating concerns and psychological distress, with effects sustained at an 8-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting dietary restraint to reduce binge eating: a randomised controlled trial of a blended internet- and smartphone app-based intervention. Linardon, J., Messer, M., Shatte, A., et al.[2023]

The study involving 66 participants with binge-eating disorder or bulimia nervosa found that the Noom Monitor app combined with guided self-help treatments (CBT-GSH) significantly reduced objective bulimic episodes compared to traditional CBT-GSH alone.

Participants using the Noom app showed better adherence to meal and snack guidelines, which helped mediate the treatment's effectiveness, although both treatments had similar remission rates at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. Hildebrandt, T., Michaelides, A., Mackinnon, D., et al.[2023]

Cognitive-behavioral therapy led by a therapist (CBTth) is significantly more effective than guided self-help (CBTgsh) for treating binge-eating disorder, with a 20-fold higher likelihood of treatment completion and nearly 15-fold higher likelihood of remission based on a study of 457 participants.

Weight concern plays a crucial role in treatment outcomes, with lower weight concern associated with better remission rates in both CBT methods, but longer treatment duration positively impacts remission in CBTth while negatively affecting CBTgsh.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical moderators and predictors of cognitive-behavioral therapy by guided-self-help versus therapist-led for binge-eating disorder: Analysis of aggregated clinical trials. Grilo, CM., Thompson-Brenner, H., Shingleton, RM., et al.[2022]

An acceptance-facilitating intervention (AFI) significantly improved acceptance ratings of digital interventions for binge eating among 398 participants, highlighting its effectiveness in addressing misconceptions and promoting positive attitudes.

Despite the increased acceptance, there were no differences in the actual usage or adherence rates to the digital interventions between the AFI and control groups, suggesting that while acceptance can be enhanced, it does not necessarily translate to increased engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Acceptance-Facilitating Intervention on Acceptance and Usage of Digital Interventions for Binge Eating. Linardon, J., Anderson, C., Chapneviss, T., et al.[2022]

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