Testing SHAPE: A Single-Session Intervention Targeting Binge Eating in Women Through Assessment a… (NCT07217847) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Testing SHAPE: A Single-Session Intervention Targeting Binge Eating in Women Through Assessment and Values-Based Strategies
United States56 participantsStarted 2025-10
Plain-language summary
The goal of this controlled trial is to learn whether a brief single-session intervention (SSI) can reduce binge eating symptoms by targeting overvaluation of weight/shape in women with recurrent binge eating.
The main questions it aims to answer are:
* Does assessment alone reduce binge eating severity and overvaluation of weight/shape compared to a control group undergoing minimal assessment?
* Does adding a values-based reflection and goal-setting component (the full SHAPE intervention) add benefits beyond the assessment alone?
Researchers will compare three groups:
1. assessment-only,
2. full SHAPE intervention, and
3. minimal assessment control to see if both active conditions outperform the control, and whether the full intervention adds any benefits beyond the assessment itself
Participants will:
* Complete a semi-structured eating disorder assessment (Eating Disorder Examination)
* Depending on assignment, also complete a values-based reflection and goal-setting exercise with psychoeducation
* Complete follow-up assessments evaluating binge eating severity, overvaluation of weight/shape, clinical impairment, binge frequency, and related outcomes.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 18 years old
* Identify as cisgender female
* self-reported BMI ≥ 18.5 kg/m²
* Rate the extent to which their weight or shape influences how they feel about themselves as a "4" or higher on a 7-point Likert scale on screening measures
* ≥1 binge eating episode every 2 weeks (i.e., ≥ six episodes over 3 months) at the time of screening
Exclusion Criteria:
* \< 18 years old
* Assigned male at birth
* Gender identity different from biological sex indicated on birth certificate
* Purging behaviors (i.e., self-induced vomiting, laxative misuse, or diuretic misuse) ≥ 1x/week in the last 3 months at the time of screening.
* Engaged in structured psychological therapy or counseling (defined as attending sessions \> 1x/month in the past 3 months)
* Prior participation in studies that include administration of the EDE interview at Ohio University (IRB-FY24-403, IRB-FY25-330, and IRB-21-F-14).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.