30 Participants Needed

Digital Intervention for Binge Eating

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

Trial Summary

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 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.12345

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.14678

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.134910

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.

Eligibility Criteria

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
See 2 more

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
See 10 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Self-Help Digital InterventionExperimental Treatment1 Intervention
All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm.

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

Effects of an Acceptance-Facilitating Intervention on Acceptance and Usage of Digital Interventions for Binge Eating. [2022]
Effects of Participant's Choice of Different Digital Interventions on Outcomes for Binge-Spectrum Eating Disorders: A Pilot Doubly Randomized Preference Trial. [2023]
A broad v. focused digital intervention for recurrent binge eating: a randomized controlled non-inferiority trial. [2023]
Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder. [2022]
Development of a transdiagnostic digital interactive application for eating disorders: psychometric properties, satisfaction, and perceptions on implementation in clinical practice. [2023]
Targeting dietary restraint to reduce binge eating: a randomised controlled trial of a blended internet- and smartphone app-based intervention. [2023]
Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. [2022]
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]
Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Usability Evaluation of a Cognitive-Behavioral App-Based Intervention for Binge Eating and Related Psychopathology: A Qualitative Study. [2022]
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