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

NCT07217847 | Not Yet Recruiting

• 1 other identifier: IRB-FY26-100
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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:
• assessment-only,
• full SHAPE intervention, and
• minimal assessment control to see if both active conditions outperform the control, and whether the full intervention adds any benefits beyond the assessment itself
• 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

Keywords

single session; single-session consultation; single-session intervention; binge eating; disordered eating; binge-spectrum disorder; body image; body image concerns; weight/shape concerns; overvaluation; loss of control eating

Outcome Measures

Primary Outcomes (2)

• Changes in overvaluation of weight/shape

  Changes in Shape/weight overvaluation subscale score on 7-Item Eating Disorder Examination Questionnaire

  1 month

• Change in binge eating severity

  Change in scores on Binge Eating Scale

  1 month

Secondary Outcomes (6)

• Change in Body Image Flexibility

  1 month

• Change in eating self-efficacy

  1 month

• Change in readiness to change eating disorder symptoms

  1 month

• Change in eating disorder-related clinical impairment

  1 month

• Change in depressive symtpoms

  1 month

Study Arms (3)

Assessment-only

ACTIVE COMPARATOR

Diagnostic items of the Eating Disorder Examindation (EDE)

Behavioral: Assessment-only

Full Intervention (SHAPE)

ACTIVE COMPARATOR

Diagnostic items of the Eating Disorder Examindation (EDE) \+ Values-based reflection and goal-setting exercises

Behavioral: Assessment-only; Behavioral: values-based reflection and goal-setting/action-planning exercises

Minimal-Assessment Control

PLACEBO COMPARATOR

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

Behavioral: Minimal-Assessment Control

Interventions

Assessment-only BEHAVIORAL

Diagnostic items of the Eating Disorder Examindation (EDE)

Assessment-only; Full Intervention (SHAPE)

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

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

Also known as: SHAPE

Full Intervention (SHAPE)

Minimal-Assessment Control BEHAVIORAL

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

Minimal-Assessment Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• \< 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).

Sponsors & Collaborators

• Taylor Rezeppa: lead
• Ohio University: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45705, United States

Location

MeSH Terms

Conditions

Bulimia; Binge-Eating Disorder; Body Weight

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders

Study Officials

• Katherine J. Forney, Ph.D.

  Ohio University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor L Rezeppa, Master of Science

CONTACT

301-957-5805; tr036720@ohio.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Candidate in Clinical Psychology

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)