Eating Behaviors in Children and Adolescents With/Without Celiac Disease

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Celiac Disease in Children; Eating Behaviors

Study type: Observational

Funder types: Other

Identifiers

NCT07285512

DAN-CD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Celiac disease group

Description:

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

Description:

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.