Eating Behaviors in Children and Adolescents With/Without Celiac Disease: A Cross-Sectional and Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores
研究概览
简要总结
This observational study investigates the prevalence and severity of disordered eating behaviors in adolescents aged 11-17 years with celiac disease. Participants complete validated self-report questionnaires (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination Questionnaire, PEDE-Q) and a structured clinical form. A healthy control group, matched by age and sex, is included for comparison. A longitudinal sub-cohort diagnosed with celiac disease <6 months prior will be followed at 6, 12, and 24 months to evaluate changes in eating psychopathology and associated clinical variables.
详细描述
Celiac disease (CD) is a chronic autoimmune condition that requires lifelong adherence to a strict gluten-free diet. Adolescence represents a period of heightened vulnerability for the development of disordered eating behaviors, particularly in chronic conditions requiring dietary restrictions. Emerging evidence suggests that youths with CD may be at increased risk of problematic eating behaviors, including shape and weight concerns, dietary restraint, and loss-of-control eating; however, data in pediatric CD populations are limited and inconsistent.
This study aims to characterize eating-related psychopathology in adolescents aged 11-17 years with a diagnosis of CD, using validated instruments adapted for youth (Youth Eating Disorder Examination Questionnaire, YEDE-Q, and Parent Eating Disorder Examination Questionnaire, PEDE-Q). The study has both a cross-sectional and a longitudinal component.
The cross-sectional component will compare adolescents with CD to age- and sex-matched healthy controls recruited from outpatient pediatric services and local schools. Participants will complete an online self-report questionnaire battery including the YEDE-Q and a structured clinical and psychosocial survey assessing diagnostic history, gastrointestinal symptoms, lifestyle factors, adherence to the gluten-free diet, academic functioning, and co-morbidities. Parents or caregivers will complete the PEDE-Q. The primary outcome is the global score of the YEDE-Q.
The longitudinal component includes a sub-cohort of adolescents diagnosed with CD within the past six months. These participants will be reassessed at 6, 12, and 24 months post-diagnosis to evaluate trajectories of eating psychopathology and identify factors associated with the emergence, persistence, or remission of disordered eating behaviors over time.
No biological samples are collected, and no experimental interventions are administered. All data are obtained through questionnaires. The study is conducted at IRCCS Ospedale San Raffaele, Milan, Italy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Celiac Disease Group (Cases)
- •Adolescents aged 11 to 17 years
- •Confirmed diagnosis of celiac disease according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) criteria (positive serology and/or duodenal biopsy)
- •Ability to understand and complete questionnaires in Italian
- •For the longitudinal cohort: diagnosis < 6 months prior to enrollment
- •Healthy Control Group
- •Adolescents aged 11 to 17 years
- •No diagnosis of celiac disease
- •Ability to understand and complete questionnaires in Italian
排除标准
- •Significant cognitive impairment or developmental disorders preventing questionnaire completion
- •Inadequate understanding of the Italian language
- •Refusal or inability to provide assent/consent
结局指标
主要结局
Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores
时间窗: Baseline (cross-sectional assessment)
Eating disorder psychopathology will be assessed using the YEDE-Q, completed by the adolescent. This tool evaluates restraint, eating concern, shape concern, and weight concern. The primary endpoint is the global score (range 0-6), with higher values indicating greater eating-related psychopathology.
Eating Psychopathology - Parent Eating Disorder Examination Questionnaire (PEDE-Q) Global Scores
时间窗: Baseline (cross-sectional assessment)
Eating disorder psychopathology will be assessed using the PEDE-Q, completed by a caregiver. This tool evaluates restraint, eating concern, shape concern, and weight concern from the point of view of the caregiver. The primary endpoint is the global score (range 0-6), with higher values indicating greater eating-related psychopathology.
次要结局
- Associations Between Eating Psychopathology and Clinical/Psychosocial Variables(baseline)
- Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score)(6 months, 12 months, and 24 months after diagnosis)
- Longitudinal Change in Eating Psychopathology (PEDE-Q Global Scores)(6 months, 12 months, and 24 months after diagnosis)
研究者
Marina Di Stefano
Doctor
IRCCS San Raffaele