Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07285512

Eating Behaviors in Children and Adolescents With/Without Celiac Disease

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores

    Time frame: 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.

  2. Eating Psychopathology - Parent Eating Disorder Examination Questionnaire (PEDE-Q) Global Scores

    Time frame: 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.

Secondary outcomes

  1. Associations Between Eating Psychopathology and Clinical/Psychosocial Variables

    Time frame: baseline

    Associations between YEDE-Q and PEDE-Q global scores and relevant clinical and psychosocial variables will be evaluated. Variables include BMI z-score, diagnostic delay, time since diagnosis, gastrointestinal symptoms, physical activity, adherence to gluten-free diet, school functioning, and medical/psychological comorbidities.

  2. Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score)

    Time frame: 6 months, 12 months, and 24 months after diagnosis

    Among adolescents with a recent diagnosis of celiac disease (<6 months), changes in eating disorder psychopathology over time will be assessed using the Youth Eating Disorder Examination Questionnaire (YEDE-Q). Repeated measures of adolescent-reported global scores (range 0-6) will be collected to evaluate progression, persistence, improvement, or remission of disordered eating symptoms.

  3. Longitudinal Change in Eating Psychopathology (PEDE-Q Global Scores)

    Time frame: 6 months, 12 months, and 24 months after diagnosis

    Among adolescents with a recent diagnosis of celiac disease (<6 months), changes in eating disorder psychopathology over time will be assessed using the Parent Eating Disorder Examination Questionnaire (PEDE-Q). Repeated measures of parent-reported global scores (range 0-6) will be collected to evaluate progression, persistence, improvement, or remission of disordered eating symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Irene Carla Ferri, Doctor

CONTACT

[email protected]

+393209676736

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.