- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07677020
Anorexia Prevention in Female College Students
Prevention of Anorexia Nervosa in Female College Students
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Gaungdong
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Guangzhou, Gaungdong, Kina
- Jinan University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Eating Disorder Risk
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Depressive Symptoms
Tidsramme: 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
Tidsramme: 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.
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Baseline, week 4, week 8, and week 20 follow-up
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|
Body Image Flexibility
Tidsramme: 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
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|
Functionality Appreciation
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- JNUECKY-20260325-054
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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