Eating Behaviors in Children and Adolescents With/Without Celiac Disease

NCT07285512 | Not Yet Recruiting

• 1 other identifier: DAN-CD
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Celiac Disease in Children; Eating Behaviors

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Central Study Contacts

Chiara Irene Carla Ferri, Doctor

CONTACT

+393209676736; ferri.chiarairene@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 16, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share