RightFit
RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be instructed to engage with ChangeBite and attend follow up assessments on scheduled video calls."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 1. Are English speaking male or female 2. Are aged 18-70 years 3. Have recurrent objective or subjective binge eating episodes (≥12 episodes in 3 months) 4. Have BMI ≥30 5. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher 6. Are willing and able to complete enrollment procedures 7. Are able to understand the nature of the study and provide written informed consent Exclusion Criteria: 1. Are unable to fluently speak, write and read English. 2. Are already receiving treatment for an eating disorder (e.g., research participants cannot be receiving concurrent eating disorder treatment from another provider) 3. Are receiving weight loss treatment (behavioral or pharmacological) 4. 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,) 5. 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. 6. 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. 7. Are fasting for 24 hours or more, \> 3x times a week, and are not deemed safe for remote treatment by a primary care provider. 8. Are unwilling to receive medical clearance and/or medical monitoring as requested by the study to ensure they are medically safe to participate. 9. Are pregnant or planning to become pregnant within the next year. 10. 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 11. Are adults unable to consent 12. Are prisoners

Study sites (1)

PA