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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07677020
Anorexia Prevention in Female College Students
Prevention of Anorexia Nervosa in Female College Students
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This was a single-blind, three-arm, parallel-group randomized controlled trial conducted among female college students at elevated risk of eating disorders or body shape concerns. Participants were recruited from Jinan University and randomly assigned in a 1:1:1 ratio to acceptance-based embodied movement, functional fitness control, or psychoeducation.
The acceptance-based embodied movement program used low-impact mindful movements derived from yoga and tai chi and incorporated acceptance and commitment therapy techniques. The program emphasized present-moment body sensations, acceptance of appearance-related thoughts and feelings, cognitive defusion, valued action, and appreciation of body functionality. The functional fitness control program matched the movement intervention in session duration, frequency, and contact time, but removed mindfulness and acceptance components. It included aerobic and core exercises with standard fitness instruction. The psychoeducation program provided cognitive and dissonance-based body image education without physical activity.
All three programs lasted 8 weeks and were delivered in groups by trained facilitators using written manuals. Outcomes were assessed at baseline, mid-intervention, post-intervention, and 3-month follow-up. The primary outcomes were eating disorder risk measured by the Eating Disorder Examination Questionnaire Short Form and body shape concern measured by the Body Shape Questionnaire-8C. Secondary outcomes included depression, anxiety, body image flexibility, functionality appreciation, and body surveillance. Attendance, intervention fidelity, and adverse events were monitored throughout the study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gaungdong
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Guangzhou, Gaungdong, Porcelana
- Jinan University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Female undergraduate or graduate students.
- Aged 18 to 25 years.
- Elevated eating disorder risk or body shape concern based on the prespecified screening threshold.
- Physically able to participate in light-intensity physical activity.
- Provided written informed consent.
Exclusion Criteria:
- Current treatment for an eating disorder.
- Any physical condition contraindicating participation in exercise.
- Pregnancy.
- Concurrent participation in another structured body image or exercise program.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Acceptance-Based Embodied Movement
Participants received an 8-week acceptance-based embodied movement program delivered in groups.
The program used low-impact mindful movements derived from yoga and tai chi and incorporated acceptance and commitment therapy techniques, including present-moment awareness, acceptance of appearance-related thoughts and feelings, cognitive defusion, valued action, and appreciation of body functionality.
|
An 8-week group-based embodied movement program using low-impact mindful movements derived from yoga and tai chi.
The program incorporated acceptance and commitment therapy techniques, including present-moment body awareness, acceptance of appearance-related thoughts and feelings, cognitive defusion, valued action, and appreciation of body functionality.
|
|
Comparador activo: Functional Fitness Control
Participants received an 8-week functional fitness control program delivered in groups.
This program matched the embodied movement program in session duration, frequency, and contact time, but removed mindfulness and acceptance components.
It included aerobic and core exercises with standard fitness instruction focused on exertion, completion of exercises, and cardiorespiratory fitness.
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An 8-week group-based functional fitness program matched to the embodied movement program in session duration, frequency, and contact time.
The program included aerobic and core exercises with standard fitness instruction and did not include mindfulness, acceptance, or body-image-focused guidance.
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Comparador activo: Psychoeducation
Participants received an 8-week psychoeducation program delivered in groups without physical activity.
The program provided cognitive and dissonance-based body image education, including critical discussion of idealized media images, appearance-focused talk, and body-related self-esteem.
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An 8-week group-based psychoeducation program without physical activity.
The program provided cognitive and dissonance-based body image education, including critical discussion of idealized media images, appearance-focused talk, and body-related self-esteem.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Eating Disorder Risk
Periodo de tiempo: Baseline, week 4, week 8, and week 20 follow-up
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Eating disorder risk was measured using the Eating Disorder Examination Questionnaire Short Form (EDE-QS).
Higher scores indicate greater eating disorder risk.
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Baseline, week 4, week 8, and week 20 follow-up
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Body Shape Concern
Periodo de tiempo: Baseline, week 4, week 8, and week 20 follow-up
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Body shape concern was measured using the 8-item Body Shape Questionnaire (BSQ-8C).
Higher scores indicate greater body shape concern.
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Baseline, week 4, week 8, and week 20 follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depressive Symptoms
Periodo de tiempo: Baseline, week 4, week 8, and week 20 follow-up
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Depressive symptoms were measured using the 9-item Patient Health Questionnaire (PHQ-9).
Higher scores indicate more severe depressive symptoms.
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Baseline, week 4, week 8, and week 20 follow-up
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Anxiety Symptoms
Periodo de tiempo: Baseline, week 4, week 8, and week 20 follow-up
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Anxiety symptoms were measured using the 7-item Generalized Anxiety Disorder scale (GAD-7).
Higher scores indicate more severe anxiety symptoms.
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Baseline, week 4, week 8, and week 20 follow-up
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Body Image Flexibility
Periodo de tiempo: Baseline, week 4, week 8, and week 20 follow-up
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Body image flexibility was measured using the Body Image Acceptance and Action Questionnaire (BI-AAQ).
Higher scores indicate greater body image flexibility.
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Baseline, week 4, week 8, and week 20 follow-up
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Functionality Appreciation
Periodo de tiempo: Baseline, week 4, week 8, and week 20 follow-up
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Functionality appreciation was measured using the Functionality Appreciation Scale (FAS).
Higher scores indicate greater appreciation of body functionality.
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Baseline, week 4, week 8, and week 20 follow-up
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- JNUECKY-20260325-054
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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