Nutrition and Physical Activity Education in Children With Celiac Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorBahçeşehir University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Nutrition Education
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Nutrition Education + Physical Activity EducationExperimental treatment 2 interventions
Group B: Physical Activity EducationExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in eating behavior score
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.
Time frame
Baseline and week 6Secondary outcomes
1
Change in packaged gluten-free food consumption frequency
Packaged gluten-free food consumption frequency will be assessed using a researcher-developed food frequency questionnaire. The questionnaire evaluates the frequency of consumption of packaged gluten-free products and naturally gluten-free foods. Changes in consumption frequency from baseline to Week 6 will be compared between the study groups.
Time frame
Baseline and Week 62
Change in physical activity level
Physical activity level will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). The questionnaire evaluates habitual physical activity during the previous 7 days. Higher scores indicate higher physical activity levels.
Time frame
Baseline and Week 63
Change in health-related quality of life
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL 4.0), a validated 23-item questionnaire evaluating physical, emotional, social, and school functioning. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes in total and domain scores from baseline to Week 6 will be compared between the study groups.
Time frame
Baseline and Week 64
Change in daily step count
Daily physical activity will be objectively assessed using wearable activity trackers. The average daily step count recorded during the intervention period will be compared between the study groups.
Time frame
Baseline and Week 6Sponsors and contacts
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Bahçeşehir University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
Source ClinicalTrials.gov