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Not yet recruiting NCT07285512

Eating Behaviors in Children and Adolescents With/Without Celiac Disease

Observational Celiac Disease in Children Eating Behaviors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Celiac Disease in Children, Eating Behaviors. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Eating Behaviors in Children and Adolescents With/Without Celiac Disease: A Cross-Sectional and Longitudinal Study

Overview

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.

Detailed description

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.

Primary outcome measures

  • Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores [Time frame: Baseline (cross-sectional assessment)]
  • Eating Psychopathology - Parent Eating Disorder Examination Questionnaire (PEDE-Q) Global Scores [Time frame: Baseline (cross-sectional assessment)]
Secondary outcome measures (3)
  • Associations Between Eating Psychopathology and Clinical/Psychosocial Variables [Time frame: baseline]
  • Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score) [Time frame: 6 months, 12 months, and 24 months after diagnosis]
  • Longitudinal Change in Eating Psychopathology (PEDE-Q Global Scores) [Time frame: 6 months, 12 months, and 24 months after diagnosis]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Significant cognitive impairment or developmental disorders preventing questionnaire completion
  • Inadequate understanding of the Italian language
  • Refusal or inability to provide assent/consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07285512 · DAN-CD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗