A Program for the Prevention of ED in Adolescent Female Athletes, the HADAS: Protocol for a Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Eating Disorder Risk and Symptomatology
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Allocation sequence generation, baseline data management, outcome assessment, and statistical data processing are strictly conducted by independent researchers who are blinded to experimental assignments.
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: The HADAS Program (Behavioral)
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)
结局指标
主要结局
Eating Disorder Risk and Symptomatology
时间窗: 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.
Body Image Dissatisfaction
时间窗: 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.
次要结局
- Competitive Anxiety(Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).)
- 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).)
- 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).)
- Critical Thinking about Media(Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).)
- General knowledge about nutrition in adolescents(Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).)
- Coach controlling behaviors(Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).)
- Leadership style in sport(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(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(Baseline (T0), Immediate Post-intervention (T1), 6-month Follow-up (T2), and 12-month Follow-up (T3).)
研究者
Eva Maria Leon Zarceño
Associate Professor / Principal Investigator
Universidad Miguel Hernandez de Elche