Eating Behaviors in Children and Adolescents With/Without Celiac Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-17
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Significant cognitive impairment or developmental disorders preventing questionnaire completion
Inadequate understanding of the Italian language
Refusal or inability to provide assent/consent
Trial 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.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Celiac disease group
Group B: Healthy control group
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (cross-sectional assessment)2
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.
Time frame
Baseline (cross-sectional assessment)Secondary outcomes
1
Associations Between Eating Psychopathology and Clinical/Psychosocial Variables
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.
Time frame
baseline2
Longitudinal Change in Eating Psychopathology (YEDE-Q Global Score)
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.
Time frame
6 months, 12 months, and 24 months after diagnosis3
Longitudinal Change in Eating Psychopathology (PEDE-Q Global Scores)
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.
Time frame
6 months, 12 months, and 24 months after diagnosisLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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