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?

The proposed study is an open label, non randomized, waitlist controlled single group feasibility study of the feasibility and usability of a digital intervention (called ChangeBite) to be used by individuals with obesity and comorbid binge eating behavior. The proposed research will include approximately 30 participants. Participants will be recruited for this single group pilot trial using online advertising to attend a virtual screening session. Screened participants willing and eligible to participate, will receive informed consent and formally start ChangeBite. Participants will be instructed to engage with ChangeBite and attend follow up assessments on scheduled video calls. Feasibility and acceptability of implementation will be assessed by collecting data on recruitment, retention, usability and satisfaction. The research team will also collect assessment data from participants on feasibility, and usability. In addition to self report scales, semi-structured interviews will be completed with a trained research team member via video call and will be partially recorded. Assessments will be done at baseline, 12 weeks, and 24 weeks. Participants' app use frequency and duration will be tracked using software analytics. Participants' body weight will be captured weekly using a timestamped picture of their weight as it appears on their scale and Body Mass Index will be calculated with these data points.

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.

Is the digital intervention for binge eating safe for humans?

The digital intervention for binge eating, based on cognitive-behavioral therapy (CBT), was well accepted by participants and showed positive results without any reported safety concerns in the study. ^{1 2 3 4 5}

How is the treatment ChangeBite different from other treatments for binge eating?

ChangeBite is a digital intervention that likely focuses on a specific change mechanism, which is different from traditional treatments that target multiple mechanisms. This approach may offer a more streamlined and potentially effective way to address core symptoms of binge eating. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment ChangeBite for binge eating?

Research shows that digital interventions based on cognitive-behavioral therapy (CBT) principles, similar to ChangeBite, have been effective in reducing binge eating episodes and improving related symptoms. These interventions are well-received by patients and maintain positive results over time. ^{1 2 6 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.

I am currently undergoing treatment for weight loss.

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

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

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effects of an Acceptance-Facilitating Intervention on Acceptance and Usage of Digital Interventions for Binge Eating. [2022]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A broad v. focused digital intervention for recurrent binge eating: a randomized controlled non-inferiority trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. [2022]

5. England 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. [2023]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a Cognitive-Behavioral App-Based Intervention for Binge Eating and Related Psychopathology: A Qualitative Study. [2022]