A Self-Guided Mobile Intervention for Adults With Binge Eating and Obesity

Drexel University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Binge Eating Disorder Associated With Obesity

Binge Eating Disorder

Treatments

Other: Digital

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT06817863

R41MH134704 (U.S. NIH Grant/Contract)

2408010718

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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