- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07285512
Eating Behaviors in Children and Adolescents With/Without Celiac Disease
Eating Behaviors in Children and Adolescents With/Without Celiac Disease: A Cross-Sectional and Longitudinal Study
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chiara Irene Carla Ferri, Doctor
- Phone Number: +393209676736
- Email: ferri.chiarairene@hsr.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Eating Psychopathology - Youth Eating Disorder Examination Questionnaire (YEDE-Q) Global Scores
Time Frame: Baseline (cross-sectional assessment)
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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.
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Baseline (cross-sectional assessment)
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Eating Psychopathology - Parent Eating Disorder Examination Questionnaire (PEDE-Q) Global Scores
Time Frame: Baseline (cross-sectional assessment)
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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.
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Baseline (cross-sectional assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Associations Between Eating Psychopathology and Clinical/Psychosocial Variables
Time Frame: baseline
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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.
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baseline
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Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score)
Time Frame: 6 months, 12 months, and 24 months after diagnosis
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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.
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6 months, 12 months, and 24 months after diagnosis
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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.
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6 months, 12 months, and 24 months after diagnosis
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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