Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
NCT07382999
Celiac Disease, Celiac Disease in Adolescents
Malatya, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT07285512
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.
Trial opening soon.
Get Notified11 year–17 year
All sexes
Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Celiac Disease Group (Cases)
Healthy Control Group
Exclusion criteria
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
IRCCS San Raffaele
Other
Eating Behaviors in Children and Adolescents With/Without Celiac Disease: A Cross-Sectional and Longitudinal Study
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