Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families. (The HADAS)

August 1, 2026 updated by: Eva Maria Leon Zarceño, Universidad Miguel Hernandez de Elche

A Program for the Prevention of ED in Adolescent Female Athletes, the HADAS: Protocol for a Randomized Controlled Trial Study

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eva María León Zarceño
  • Phone Number: +34 606501888
  • Email: eleon@umh.es

Study Contact Backup

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Universidad Miguel Hernández de Elche - Department of Behavioral Sciences and Health
        • Contact:
          • Eva María León Zarceño
          • Phone Number: +34 96 665 8823
          • Email: eleon@umh.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group (HADAS Program)
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
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
No Intervention: Control Group (Waitlist)
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eating Disorder Risk and Symptomatology
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychological Well-Being
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Psychological Well-Being Scale for Youth (PWB-SF-Y; Ryff, 1989; Spanish adaptation by Stavraki et al., 2022). It assesses well-being across 6 core dimensions using a single item per dimension. Items are rated on a 6-point Likert scale ranging from 1 ("strongly disagree") to 6 ("strongly agree"). Total scores range from 6 to 36, where higher scores indicate greater psychological well-being and optimal psychological functioning (a better outcome)..
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Life Satisfaction
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; Spanish validation in adolescents by Atienza et al., 2003). It assesses global cognitive judgments of one's life satisfaction across 5 items rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). Total scores range from 5 to 25, where higher scores indicate greater life satisfaction and positive cognitive evaluation of life (a better outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Competitive Anxiety
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Revised Competitive State Anxiety Inventory-2 (CSAI-2R; Martens et al., 1990; Spanish validation by Andrade et al., 2007). It assesses pre-competitive state anxiety across 16 items rated on a 4-point Likert scale ranging from 1 ("not at all") to 4 ("very much"). The inventory measures three subscales: Cognitive Anxiety (5 items; scores range from 5 to 20, where higher scores indicate higher cognitive anxiety / a worse outcome), Somatic Anxiety (6 items; scores range from 6 to 24, where higher scores indicate higher somatic anxiety / a worse outcome), and Self-Confidence (5 items; scores range from 5 to 20, where higher scores indicate greater self-confidence / a better outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Perfectionism in sports
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Multidimensional Inventory of Perfectionism in Sport (MIPS; Stoeber et al., 2006; Spanish validation by Ramírez-Muñoz et al., 2023). It assesses sport-specific perfectionism across 10 items rated on a 6-point Likert scale ranging from 1 ("never") to 6 ("always"). The inventory yields two distinct subscales (5 items each, with total scores ranging from 5 to 30 for each subscale): Striving for Perfection (evaluates personal standards of excellence) and Negative Reactions to Imperfection (evaluates negative reactions to mistakes and sensitivity to external pressure), where higher scores reflect greater maladaptive perfectionism and a worse outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Appearance awareness on social networks
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Appearance-Related Social Media Consciousness Scale (ASMC; Choukas-Bradley et al., 2020; Spanish validation by Rojo et al., 2023). It measures the ongoing awareness and body monitoring of one's physical appearance in social media contexts across 13 items rated on a 7-point Likert scale ranging from 1 ("never") to 7 ("always"). Total scores range from 13 to 91, where higher scores indicate greater appearance-related social media consciousness and body surveillance (a worse outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Critical Thinking about Media
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Critical Thinking About Media Messages Scale (CTMM; Scull et al., 2010; Spanish validation by Rojo et al., 2023). It assesses the degree to which individuals critically analyze and evaluate aesthetic and appearance-focused media messages across 6 items rated on a 6-point Likert scale ranging from 1 ("never") to 6 ("always"). Total scores range from 6 to 36, where higher scores indicate greater critical thinking toward media and social media messages (a better outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
General knowledge about nutrition in adolescents
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Questionnaire on Nutrition Knowledge for Adolescents (C.A.P.A.; Ladrón-Arana et al., 2021). It assesses nutritional literacy and general healthy eating knowledge in adolescents across 26 multiple-choice items (with 4 response options per item). Each correct response is awarded 1 point, yielding total scores ranging from 0 to 26, where higher scores indicate greater general nutritional knowledge and dietary literacy (a better outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Coach controlling behaviors
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Controlling Coach Behaviors Scale (CCBS; Bartholomew et al., 2010; Spanish validation by Castillo et al., 2014). It measures athletes' perceptions of their coach's controlling interpersonal style across 15 items rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The scale assesses four subscales: Controlling Use of Rewards (4 items), Negative Conditional Regard (4 items), Intimidation (4 items), and Excessive Personal Control (3 items). Total scores range from 15 to 105, where higher scores reflect higher perceived controlling behaviors from the coach (a worse outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Leadership style in sport
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the Leadership Scale for Sports (LSS; Chelladurai & Saleh, 1980; Spanish validation by Crespo et al., 1994). It assesses perceived coaching leadership behaviors across 31 items rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("always"). The Spanish adaptation measures 4 dimensions: Relationship-Oriented Behavior (13 items), Task-Oriented Behavior (10 items), Democratic Behavior (4 items), and Autocratic Behavior (4 items). Dimension mean scores range from 1 to 5, where higher scores in Relationship-Oriented, Task-Oriented, and Democratic behaviors reflect more supportive and adaptive leadership styles (a better outcome).
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Coach Eating Disorder Literacy and Warning Signs Knowledge
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the ad hoc Coach Eating Disorder Knowledge Questionnaire, created specifically for the HADAS Program by its research group to evaluate program-specific learning objectives. The instrument was developed and validated via a four-stage process (item generation, expert panel review, scoring design, and pilot testing). It assesses sports-specific eating disorder (ED) literacy across 25 items structured in 5 core dimensions: (1) General multi-causal etiology (items 1-6); (2) Identification of behavioral/emotional warning signs in sports contexts (items 7-11); (3) Risk and protective factors in competitive environments (items 12-16); (4) Consequences on physical health and performance (items 17-20); and (5) Early detection and intervention protocols (items 21-25). Items use a True/False/I Don't Know (1 point for correct responses; 0 points for others). Total scores range from 0 to 25, where higher scores indicate higher sports-specific ED literacy and detection competence
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Parental Eating Disorder Literacy and Warning Signs Knowledge
Time Frame: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
Evaluated using the ad hoc Family Eating Disorder Knowledge Questionnaire, created specifically for the HADAS Program by its research group to align directly with the family intervention curriculum. The instrument was developed and validated via a four-stage process (item generation, expert panel review, scoring design, and pilot testing). It assesses family eating disorder literacy and management across 25 items structured in 5 core dimensions: (1) General ED knowledge (items 1-6); (2) Symptom identification in adolescent athletes (items 7-11); (3) Interpretation and behavioral action plans (items 12-15); (4) Risk and protective factors (items 16-19); and (5) Language, media literacy, and family role (items 20-25). Items use a True/False/I Don't Know format (1 point for correct responses; 0 points for incorrect or 'I Don't Know' answers). Total scores range from 0 to 25, where higher scores indicate greater parental eating disorder literacy and proactive family management skills.
Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Miguel Hernandez de Elche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCC.ELZ.251124
  • https://doi.org/10.17605/OSF.I (Registry Identifier: Open Science Framework (OSF))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available after the primary manuscript publishing the final longitudinal findings is accepted

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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