NCT07750301

Brief Summary

Adolescent female athletes in aesthetic sports disciplines (such as rhythmic gymnastics, artistic gymnastics, synchronized swimming, and figure skating) face a complex interaction between general sociocultural beauty pressures and sport-specific aesthetic demands (e.g., the 'slim to win' culture and weight-focused performance expectations). These combined pressures significantly increase their risk of developing body dissatisfaction and eating disorders (EDs). To address these systemic vulnerabilities, the HADAS Program (Habits, Eating, Sports, Adolescents, and Health) was developed as a multi-level, synchronized psychoeducational intervention designed to target the complete "sports triangle": adolescent female athletes, their technical coaches, and their immediate family members. The primary objective of this cluster randomized controlled trial (cluster RCT) is to evaluate the efficacy of the HADAS Program in reducing eating disorder risk (EAT-26) and body image dissatisfaction (BSQ-34) among competitive adolescent female athletes aged 12 to 16 years. Sports clubs are randomly assigned to either the Experimental Group (receiving the HADAS intervention) or a Waitlist Control Group (maintaining standard training). The program includes 5 interactive group sessions for athletes, 4 reflective workshops for coaches, and 2 structured sessions for family members, all supported by cohort-specific workbooks. Outcomes are evaluated across four longitudinal time points: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

August 6, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 28, 2026

Last Update Submit

August 1, 2026

Conditions

Keywords

Eating DisordersPrimary PreventionAdolescent HealthAesthetic SportsSports PsychologyFamily RelationsHealth Education

Outcome Measures

Primary Outcomes (2)

  • Eating Disorder Risk and Symptomatology

    Evaluated using the Eating Attitudes Test (EAT-26; Garner et al., 1982; Spanish validation by Rivas et al., 2010). It assesses eating disorder risk behaviors and attitudes across 26 items. Total scores range from 0 to 78, where higher scores indicate greater eating disorder risk and symptomatology (a worse outcome) . Scores of 20 or higher indicate the presence of significant risk attitudes toward eating.

    Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

  • Body Image Dissatisfaction

    Evaluated using the Body Shape Questionnaire (BSQ-34; Cooper et al., 1987; Spanish validation by Raich et al., 1996). It assesses body dissatisfaction and concern with weight and shape across 34 items. Total scores range from 34 to 204, where higher scores indicate greater body dissatisfaction and psychological distress regarding body image (a worse outcome). Scores are categorized into no dissatisfaction (\<80), mild (80-110), moderate (111-140), and severe (\>140), with moderate and severe categories indicating significant body image vulnerability.

    Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

Secondary Outcomes (11)

  • Psychological Well-Being

    Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

  • Life Satisfaction

    Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

  • Competitive Anxiety

    Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

  • Perfectionism in sports

    Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

  • Appearance awareness on social networks

    Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

  • +6 more secondary outcomes

Study Arms (2)

Experimental Group (HADAS Program)

EXPERIMENTAL

Sports clubs randomly assigned to receive the multi-level HADAS Program . The intervention is synchronized across three modalities: 5 interactive group sessions (90 min each) for adolescent female athletes, 4 reflective training sessions (90 min each) for technical coaches, and 2 structured psychoeducational workshops (120 min each) for parents/family members

Behavioral: The HADAS Program

Control Group (Waitlist)

NO INTERVENTION

Sports clubs randomly assigned to the control condition maintain their standard active training routines and schedule without any component of the prevention program during the 12-month study window . They will be offered the HADAS intervention after the final longitudinal follow-up (T3)

Interventions

A synchronized, multi-level psychoeducational prevention program designed to target eating disorder risk and body image dissatisfaction across the sports triangle (athletes, coaches, and families). Content focuses on media literacy, healthy life habits, emotional management, deconstructing body-weight myths in aesthetic sports, and promoting autonomy-supportive coaching and family environments

Experimental Group (HADAS Program)

Eligibility Criteria

Age12 Years - 16 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Athletes: Female gender; aged between 12 and 16 years old; actively possessing a formal federation license in an aesthetic sport discipline (e.g., rhythmic gymnastics, artistic gymnastics, synchronized swimming, figure skating) within Spain; providing signed informed assent concurrently with written informed consent from parents/legal representatives; and presenting no active, formal clinical diagnosis of an eating disorder (ED).
  • Coaches: Serving as a primary trainer or technical staff member within the participating sports club; and providing written informed consent.
  • Family Members: Operating as the primary parent, guardian, or legal representative of an included athlete; and providing written informed consent.

You may not qualify if:

  • Athletes: Presenting a current, formal clinical diagnosis of an eating disorder (e.g., Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, or ARFID) at baseline (T0); or refusal to provide informed assent or parental consent.
  • Non-compliance or failure to provide signed informed consent from coaches or primary legal guardians.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Miguel Hernández de Elche - Department of Behavioral Sciences and Health

Elche, Alicante, 03202, Spain

Location

Related Links

MeSH Terms

Conditions

Feeding and Eating DisordersHealth Education

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Eva María León Zarceño

    Universidad Miguel Hernández de Elche

    PRINCIPAL INVESTIGATOR
  • Josué López Pozo

    Universidad Miguel Hernández de Elche

    PRINCIPAL INVESTIGATOR
  • Yolanda Quiles Marcos

    Universidad Miguel Hernández de Elche

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva María León Zarceño

CONTACT

Josué López Pozo

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation sequence generation, baseline data management, outcome assessment, and statistical data processing are strictly conducted by independent researchers who are blinded to experimental assignments.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial with longitudinal tracking across four time points (T0, T1, T2, T3). Randomization is executed at the sports club level (cluster RCT) to avoid contamination among athletes within the same training environment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor / Principal Investigator

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 6, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

August 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be made available to qualified researchers upon reasonable request submitted to the principal investigator. Data sharing will be subject to ethical review, a formal data-sharing agreement, and strict compliance with European Union GDPR regulations to safeguard minor participants' confidentiality.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available after the primary manuscript publishing the final longitudinal findings is accepted
Access Criteria
Individual participant data will not be publicly shared to protect minor participants' confidentiality in compliance with GDPR and local data protection regulations. Aggregate data and protocol materials are available upon request

Locations