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

Официальное название

Testing a Single-session Consultation for Reducing Binge Eating

Обзор

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.

Вмешательства

• Поведенческое Assessment-only
  Diagnostic items of the Eating Disorder Examindation (EDE)
• Поведенческое values-based reflection and goal-setting/action-planning exercises
  Assessment-only intervention + values-based reflection and goal-setting/action-planning exercises
• Поведенческое Minimal-Assessment Control
  Invovles completing only the Intro/Eating Pattern + Bulimic Episodes/Overeating Sections of Eating Disorder Examination (EDE)

Первичные конечные точки

• Changes in overvaluation of weight/shape [Срок оценки: 1 month]
• Change in binge eating severity [Срок оценки: 1 month]

Вторичные конечные точки (6)

• Change in Body Image Flexibility [Срок оценки: 1 month]
• Change in eating self-efficacy [Срок оценки: 1 month]
• Change in readiness to change eating disorder symptoms [Срок оценки: 1 month]
• Change in eating disorder-related clinical impairment [Срок оценки: 1 month]
• Change in depressive symtpoms [Срок оценки: 1 month]
• Change in binge eating frequency [Срок оценки: 1 month]

Критерии участия

Критерии включения

• ≥ 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

Критерии исключения

• < 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ohio University — Athens

Идентификаторы

NCT: NCT07217847 · IRB-FY26-100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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