- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677020
Anorexia Prevention in Female College Students
Prevention of Anorexia Nervosa in Female College Students
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gaungdong
-
Guangzhou, Gaungdong, China
- Jinan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
Active Comparator: 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Disorder Risk
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JNUECKY-20260325-054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorder Risk
-
University of CyprusUnknownEating Disorders in Adolescence | High Risk for Eating Disorder | Acceptance ProcessesCyprus
-
University of Sao Paulo General HospitalActive, not recruitingBinge Eating DisorderBrazil
-
University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
-
Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloCompletedBinge-Eating Disorder | Eating Disorders | Eating Behavior | Eating Disorder | Binge Eating Disorder Associated With ObesityBrazil
-
ShireCompleted
-
Lindner Center of HOPEUniversity of CincinnatiCompleted
-
Axsome Therapeutics, Inc.Enrolling by invitationBinge-Eating DisorderUnited States
-
BioprojetCompleted
-
Nova Scotia Health AuthorityCompletedBinge-Eating Disorder | Eating DisorderCanada
-
Axsome Therapeutics, Inc.RecruitingBinge-Eating DisorderUnited States
Clinical Trials on Acceptance-Based Embodied Movement
-
University of ThessalyAristotle University Of ThessalonikiRecruitingHealthy Volunteers | Health PromotionGreece
-
National and Kapodistrian University of AthensUnknownColorectal Neoplasms | Pain, Procedural | Acceptance ProcessGreece
-
University of Alabama at BirminghamChildrens of Alabama Kaul Pediatric Research InstituteCompletedPediatric Obesity | Executive FunctionUnited States
-
University of ManitobaCompleted
-
Temple UniversityRush UniversityRecruiting
-
Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The...CompletedType 2 DiabetesUnited States
-
University of Massachusetts, BostonNational Institute of Mental Health (NIMH)CompletedAnxiety Disorders | Generalized Anxiety DisorderUnited States
-
Rush University Medical CenterCompleted
-
Towson UniversityDuke University; University of the Sciences in PhiladelphiaCompletedAnorexia Nervosa | Subthreshold Anorexia Nervosa | Eating Disorder Not Otherwise Specified, Primarily RestrictionUnited States
-
University of ManitobaNot yet recruiting