New treatment option for Binge Eating Disorder Associated With Obesity
Official title A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity
ClinicalTrials.gov ID: NCT06817863
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
- Are adults unable to consent
- Are prisoners
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.