Eating Behaviors in Children and Adolescents With/Without Celiac Disease
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Celiac Disease in Children, Eating Behaviors. Базовые параметры: 11 лет — 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
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- Следующий шаг
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Официальное название
Eating Behaviors in Children and Adolescents With/Without Celiac Disease: A Cross-Sectional and Longitudinal Study
Обзор
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.
Подробное описание
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.
The overarching goal is to improve early recognition of disordered eating in adolescents with CD, inform clinical practice, and contribute foundational data for future preventive interventions in this population.
Первичные конечные точки
- Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores [Срок оценки: Baseline (cross-sectional assessment)]
- Eating Psychopathology - Parent Eating Disorder Examination Questionnaire (PEDE-Q) Global Scores [Срок оценки: Baseline (cross-sectional assessment)]
Вторичные конечные точки (3)
- Associations Between Eating Psychopathology and Clinical/Psychosocial Variables [Срок оценки: baseline]
- Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score) [Срок оценки: 6 months, 12 months, and 24 months after diagnosis]
- Longitudinal Change in Eating Psychopathology (PEDE-Q Global Scores) [Срок оценки: 6 months, 12 months, and 24 months after diagnosis]
Критерии участия
Критерии включения
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
Критерии исключения
- Significant cognitive impairment or developmental disorders preventing questionnaire completion
- Inadequate understanding of the Italian language
- Refusal or inability to provide assent/consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07285512 · DAN-CD