NCT06817863 · Drexel University
A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
What this study is about
The proposed study is an open label, non randomly assigned, 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.
View original scientific description
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.
Interventions
OTHER
Digital
This intervention is a self-help digital treatment, delivered via a smartphone application, for adults with co-morbid binge eating and obesity. The app ChangeBite will integrate principles of evidence based treatments for obesity (behavioral weight loss treatment) and binge eating (cognitive behavioral therapy, acceptance and commitment therapy) into a highly personalized, self-guided, program that leverages an artificial conversational agent and Just-In-Time-Adaptive-Interventions (JITAIs).
Primary outcome measures
Binge eating episodes
Time frame: 3 months
The frequency of binge eating episodes.
Weight
Time frame: 3 months
Weight loss during the intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Are English speaking male or female
- Are aged 18-70 years
- Have recurrent objective or subjective binge eating episodes (≥12 episodes in 3 months)
- Have BMI ≥30
- Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
- Are willing and able to complete enrollment procedures
- Are able to understand the nature of the study and provide written informed consent
Exclusion criteria
- Are unable to fluently speak, write and read English.
- Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider)
- Are receiving weight loss treatment (behavioral or pharmacological)
- Have a mental handicap or are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., imminent or high risk for suicide, substance use disorder, active psychotic disorder,)
- Are purging and/or using laxatives 3 or more times per week and are not deemed safe for remote treatment by a primary care provider.
- Are exercising 2 or more hours a day on average, or engaging in significantly harmful compensatory behaviors (i.e., \> 3x/week of self-induced vomiting or laxative use), and are not deemed safe for remote treatment by a primary care provider.
- Are fasting for 24 hours or more, \> 3x times a week, and are not deemed safe for remote treatment by a primary care provider.
- Are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate.
- Are pregnant or planning to become pregnant within the next year.
- Are individuals who are not yet adults (infants, children, teenagers) Are currently taking any of these medications: Haldol, Loxitane, Mellaril, Moban, Navane, Prolixin, Serentil, Stelaxine, Trilafon, Thoraxine, Abilify, Clozaril, Geodon, Risperdal, Seroquel, Zyprexa
- Are adults unable to consent
- Are prisoners
Where
- Philadelphia, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH), Oui Therapeutics, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2025 · Source of record for eligibility and locations