Eating Behaviors in Children and Adolescents With/Without Celiac Disease

December 12, 2025 updated by: Marina Di Stefano, IRCCS San Raffaele

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

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.

Study Overview

Status

Not yet recruiting

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will enroll adolescents aged 11-17 years, including two groups: (1) patients with a confirmed diagnosis of celiac disease, and (2) healthy controls matched by age and sex. Participants in the celiac disease group are recruited from the Pediatric Unit of IRCCS Ospedale San Raffaele and must have a diagnosis established according to ESPGHAN guidelines; a subset diagnosed within the previous 6 months will be included in a longitudinal follow-up. Healthy controls are recruited from outpatient pediatric clinics and local schools and must have no chronic medical conditions requiring dietary therapy. All participants must be able to understand Italian and complete self-report questionnaires, with a caregiver available to complete the parent-report instrument.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Celiac disease group
Adolescents aged 11-17 years with a confirmed diagnosis of celiac disease, established according to the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) criteria (positive serology and/or duodenal biopsy). Participants may be at any time point after diagnosis for the cross-sectional component. A sub-cohort diagnosed <6 months prior to enrollment will participate in the longitudinal follow-up at 6, 12, and 24 months. No interventions are administered; participants complete self-report questionnaires (YEDE-Q) and parents complete the PEDE-Q, along with a structured clinical and psychosocial survey.
Healthy control group
Adolescents aged 11-17 years without celiac disease or other chronic medical conditions requiring dietary therapy. Controls are matched to the CD group by age and sex. They are recruited from the general pediatric population of the hospital and from local schools. Participants complete the same self-report questionnaires (YEDE-Q) and structured survey; parents complete the PEDE-Q. Controls are included only in the cross-sectional comparison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (cross-sectional assessment)
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.
Baseline (cross-sectional assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
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
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.
6 months, 12 months, and 24 months after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2028

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAN-CD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. The dataset contains sensitive information from minors regarding health status and eating psychopathology, and sharing identifiable or potentially re-identifiable data is not permitted under institutional and ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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