Binge Eating Disorder Associated With ObesityPhase 1/2NCT06817863
A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
A Phase 1/2 study testing Digital in people with Binge Eating Disorder Associated With Obesity and Binge Eating Disorder, run by Drexel University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Binge Eating Disorder Associated With Obesity, Binge Eating Disorder
- What is being tested?
- Digital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2025to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19139
Stephanie Dr. Manasse, PhD, 510-520-6362, smm522@drexel.edu
Alexandra Mouangue, BA, 2408838111, am5562@drexel.edu
About this study
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.
- Being tested
- Digital
- Keywords
- digital treatment, self-help intervention, binge eating
- Medical subject headings
- Binge-Eating Disorder, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DigitalOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Self-Help Digital Intervention | Experimental | All study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm. Receives: Other: Digital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge eating episodes
The frequency of binge eating episodes.
Measured: 3 months
Weight
Weight loss during the intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating Disorder Associated With ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Oui Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817863
- Sponsor's protocol ID
- 2408010718
- Other IDs
- R41MH134704
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
- ClinicalTrials.gov ID
- NCT06817863
- Acronym / sponsor ID
- 2408010718
- Keywords
- digital treatment, self-help intervention, binge eating
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Oui Therapeutics, Inc.
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Help Digital Intervention | Experimental | Other: DigitalAll study participants will receive the digital intervention (ChangeBite). Therefore, this study has 1 arm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DigitalThis 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). | Other | Self-Help Digital Intervention |
Primary outcome
Binge eating episodes
Time frame: 3 months
The frequency of binge eating episodes.
Weight
Time frame: 3 months
Weight loss during the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Digital in people with Binge Eating Disorder Associated With Obesity and Binge Eating Disorder, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge eating episodes (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.