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Recruiting Not applicable

Nutrition and Physical Activity Education in Children With Celiac Disease

NCT07750795 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-08-06

Condition(s) studied

Celiac DiseaseCeliac Disease in ChildrenCeliac Disease in Adolescents

Investigational drug(s) / intervention(s)

Nutrition EducationPhysical Activity Education

Nutrition Education: Participants will receive a one-session structured nutrition education program focusing on healthy gluten-free dietary practices. The education will include information on gluten-containing foods, prevention of cross-contamination, healthy naturally gluten-free alternatives, reducing packaged and ultra-processed gluten-free food consumption, food label reading, and balanced meal planning. Participants will receive educational materials and will be followed weekly online for 6 weeks to reinforce the educational content.

Physical Activity Education: Participants will receive a structured physical activity education program consisting of one educational session followed by a 6-week home-based exercise program. The program includes aerobic, strengthening, balance, flexibility, and coordination exercises performed twice weekly, supported by an exercise booklet and weekly online follow-up sessions to encourage adherence.

Study summary

Celiac disease is a chronic immune-mediated disorder that requires lifelong adherence to a gluten-free diet. Despite dietary treatment, children with celiac disease may experience nutritional inadequacies, unhealthy eating behaviors, reduced physical activity, and impaired quality of life. This randomized, single-blind, controlled trial aims to evaluate the effects of a structured nutrition education program combined with physical activity education on anthropometric measurements, eating behavior, physical activity, and health-related quality of life in children aged 8-12 years with celiac disease. Fifty-four participants will be randomly assigned to one of three groups: (1) nutrition and physical activity education, (2) physical activity education only, or (3) no education (control). Outcomes will be assessed at baseline and after a 6-week follow-up using validated questionnaires, anthropometric measurements, body composition analysis, and physical performance tests. The findings are expected to provide evidence for multidisciplinary educational interventions to improve the health and well-being of children with celiac disease.

Eligibility

Sex
ALL
Min age
8 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria Children aged 8 to 12 years (inclusive). Clinically diagnosed with celiac disease. Following a gluten-free diet for at least 6 months before enrollment. Able to understand study instructions and complete study assessments. Parent or legal guardian able to provide written informed consent. Child able to provide assent to participate. Exclusion Criteria Following a gluten-free diet for reasons other than celiac disease. Age younger than 8 years or older than 12 years. Refusal or inability of the parent/legal guardian to provide informed consent or of the child to provide assent. Any physical disability or medical condition that would limit participation in the physical activity program.

Primary outcome measure(s)

  • Change in eating behavior score — Baseline and week 6
    Eating behavior will be assessed using the Children's Eating Behavior Scale, a validated 19-item questionnaire consisting of five subdomains (Family, Skills, Negativity, Emotion, and Permission). Each item is rated on a 5-point Likert scale, and the mean total score will be calculated. Higher scores indicate greater expression of the assessed eating behavior characteristics. Changes in the total eating behavior score from baseline to Week 6 will be compared between the study groups.

Trial sites (1)

FacilityCityRegionStatus
Bahcesehir University Istanbul Besiktas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07750795 on ClinicalTrials.gov ↗ ← All trials in Turkey