Testing SHAPE: A Single-Session Intervention Targeting Binge Eating in Women Through Assessment and Values-Based Strategies

NCT ID: NCT07217847

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-05-31

Brief 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.

Conditions

Binge Eating; Binge Eating Behaviour; Binge Eating/Loss of Control Eating; Body Image; Body Image Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Assessment-only

Diagnostic items of the Eating Disorder Examindation (EDE)

Group Type: ACTIVE_COMPARATOR

Assessment-only

Intervention Type: BEHAVIORAL

Diagnostic items of the Eating Disorder Examindation (EDE)

Full Intervention (SHAPE)

Diagnostic items of the Eating Disorder Examindation (EDE)

+ Values-based reflection and goal-setting exercises

Group Type: ACTIVE_COMPARATOR

Assessment-only

Intervention Type: BEHAVIORAL

Diagnostic items of the Eating Disorder Examindation (EDE)

values-based reflection and goal-setting/action-planning exercises

Intervention Type: BEHAVIORAL

Assessment-only intervention + values-based reflection and goal-setting/action-planning exercises

Minimal-Assessment Control

Intro/Eating Pattern + Bulimic Episodes/Overeating Sections of Eating Disorder Examindation (EDE)

Group Type: PLACEBO_COMPARATOR

Minimal-Assessment Control

Intervention Type: BEHAVIORAL

Invovles completing only the Intro/Eating Pattern + Bulimic Episodes/Overeating Sections of Eating Disorder Examination (EDE)

Interventions

Assessment-only

Diagnostic items of the Eating Disorder Examindation (EDE)

Intervention Type: BEHAVIORAL

values-based reflection and goal-setting/action-planning exercises

Assessment-only intervention + values-based reflection and goal-setting/action-planning exercises

Intervention Type: BEHAVIORAL

Minimal-Assessment Control

Invovles completing only the Intro/Eating Pattern + Bulimic Episodes/Overeating Sections of Eating Disorder Examination (EDE)

Intervention Type: BEHAVIORAL

Other Intervention Names

SHAPE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio University

OTHER

Sponsor Role: collaborator

Taylor Rezeppa

OTHER

Sponsor Role: lead

Responsible Party

Taylor Rezeppa

Doctoral Candidate in Clinical Psychology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Katherine J. Forney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio University

Locations

Ohio University

Athens, Ohio, United States

Countries

United States

Central Contacts

Taylor L Rezeppa, Master of Science

Role: CONTACT

tr036720@ohio.edu

301-957-5805

Facility Contacts

Taylor L Rezeppa, M.S.

Role: primary

tr036720@ohio.edu

3019575805

Katherine J. Forney, Ph.D.

Role: backup

forney@ohio.edu

Other Identifiers

IRB-FY26-100

Identifier Type: -

Identifier Source: org_study_id