- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07750301
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families. (The HADAS)
1 de agosto de 2026 actualizado por: 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).
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
236
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Eva María León Zarceño
- Número de teléfono: +34 606501888
- Correo electrónico: eleon@umh.es
Copia de seguridad de contactos de estudio
- Nombre: Josué López Pozo
- Número de teléfono: +34 616510686
- Correo electrónico: josue.lopezp@umh.es
Ubicaciones de estudio
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Alicante
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Elche, Alicante, España, 03202
- Universidad Miguel Hernández de Elche - Department of Behavioral Sciences and Health
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Contacto:
- Eva María León Zarceño
- Número de teléfono: +34 96 665 8823
- Correo electrónico: eleon@umh.es
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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
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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
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Sin intervención: 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)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Eating Disorder Risk and Symptomatology
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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.
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Body Image Dissatisfaction
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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.
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Psychological Well-Being
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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)..
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Life Satisfaction
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Competitive Anxiety
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Perfectionism in sports
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Appearance awareness on social networks
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Critical Thinking about Media
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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General knowledge about nutrition in adolescents
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Coach controlling behaviors
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Leadership style in sport
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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).
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Coach Eating Disorder Literacy and Warning Signs Knowledge
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Parental Eating Disorder Literacy and Warning Signs Knowledge
Periodo de tiempo: Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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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.
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Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Eva María León Zarceño, Universidad Miguel Hernández de Elche
- Investigador principal: Josué López Pozo, Universidad Miguel Hernández de Elche
- Investigador principal: Yolanda Quiles Marcos, Universidad Miguel Hernández de Elche
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de octubre de 2028
Finalización del estudio (Estimado)
1 de mayo de 2029
Fechas de registro del estudio
Enviado por primera vez
28 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de agosto de 2026
Publicado por primera vez (Actual)
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Signos y Síntomas Digestivos
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Intervenciones de adherencia
- Adherencia a la medicación
- Trastornos de la alimentación y la alimentación
- Educación para la salud
Otros números de identificación del estudio
- DCC.ELZ.251124
- https://doi.org/10.17605/OSF.I (Identificador de registro: Open Science Framework (OSF))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Data will become available after the primary manuscript publishing the final longitudinal findings is accepted
Criterios de acceso compartido de IPD
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
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .