- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07677020
Anorexia Prevention in Female College Students
Prevention of Anorexia Nervosa in Female College Students
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gaungdong
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Guangzhou, Gaungdong, 중국
- Jinan University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
|
활성 비교기: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Eating Disorder Risk
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depressive Symptoms
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- JNUECKY-20260325-054
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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