- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07677020
Anorexia Prevention in Female College Students
Prevention of Anorexia Nervosa in Female College Students
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Gaungdong
-
Guangzhou, Gaungdong, Китай
- Jinan University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Активный компаратор: 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.
|
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.
|
|
Активный компаратор: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Eating Disorder Risk
Временное ограничение: Baseline, week 4, week 8, and week 20 follow-up
|
Eating disorder risk was measured using the Eating Disorder Examination Questionnaire Short Form (EDE-QS).
Higher scores indicate greater eating disorder risk.
|
Baseline, week 4, week 8, and week 20 follow-up
|
|
Body Shape Concern
Временное ограничение: Baseline, week 4, week 8, and week 20 follow-up
|
Body shape concern was measured using the 8-item Body Shape Questionnaire (BSQ-8C).
Higher scores indicate greater body shape concern.
|
Baseline, week 4, week 8, and week 20 follow-up
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Depressive Symptoms
Временное ограничение: Baseline, week 4, week 8, and week 20 follow-up
|
Depressive symptoms were measured using the 9-item Patient Health Questionnaire (PHQ-9).
Higher scores indicate more severe depressive symptoms.
|
Baseline, week 4, week 8, and week 20 follow-up
|
|
Anxiety Symptoms
Временное ограничение: Baseline, week 4, week 8, and week 20 follow-up
|
Anxiety symptoms were measured using the 7-item Generalized Anxiety Disorder scale (GAD-7).
Higher scores indicate more severe anxiety symptoms.
|
Baseline, week 4, week 8, and week 20 follow-up
|
|
Body Image Flexibility
Временное ограничение: Baseline, week 4, week 8, and week 20 follow-up
|
Body image flexibility was measured using the Body Image Acceptance and Action Questionnaire (BI-AAQ).
Higher scores indicate greater body image flexibility.
|
Baseline, week 4, week 8, and week 20 follow-up
|
|
Functionality Appreciation
Временное ограничение: Baseline, week 4, week 8, and week 20 follow-up
|
Functionality appreciation was measured using the Functionality Appreciation Scale (FAS).
Higher scores indicate greater appreciation of body functionality.
|
Baseline, week 4, week 8, and week 20 follow-up
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- JNUECKY-20260325-054
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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