Celiac Disease, Celiac Disease in Adolescents, Celiac Disease in Children
Conditions
Brief 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.
Detailed description
Celiac disease is a chronic immune-mediated enteropathy triggered by gluten ingestion in genetically susceptible individuals. Lifelong adherence to a strict gluten-free diet is currently the only effective treatment. Although a gluten-free diet promotes intestinal healing, many children with celiac disease continue to experience nutritional inadequacies due to the frequent consumption of highly processed gluten-free products, which are often high in sugar and saturated fat while being low in dietary fiber and essential micronutrients. These dietary patterns may negatively affect growth, body composition, eating behaviors, and long-term health outcomes. Children with celiac disease may also exhibit lower levels of physical activity, reduced muscle strength, decreased bone mineralization, and diminished quality of life. Previous studies have suggested beneficial effects of nutrition education and physical activity separately; however, evidence regarding the effectiveness of a multidisciplinary intervention combining both approaches in pediatric patients with celiac disease remains limited. This study is a single-blind, randomized, controlled trial designed to evaluate the effectiveness of a structured nutrition education program combined with physical activity education in children with celiac disease. A total of 54 children aged 8 to 12 years who have been following a gluten-free diet for at least six months will be randomly allocated into one of three study groups: (1) nutrition education plus physical activity education, (2) physical activity education only, or (3) a control group receiving no education during the intervention period. Participants will be followed for six weeks. Baseline and post-intervention assessments will include anthropometric measurements, body composition analysis using bioelectrical impedance analysis, dietary assessment, eating behavior, health-related quality of life, physical activity level, lower extremity muscle strength, flexibility, and objective monitoring of daily physical activity using wearable activity trackers. Nutrition education will focus on healthy gluten-free dietary choices, reducing consumption of ultra-processed gluten-free foods, preventing cross-contamination, and promoting balanced eating habits. The physical activity education program will include supervised instruction on strengthening, aerobic, flexibility, balance, and coordination exercises, supported by educational materials and weekly online follow-up sessions. The primary objective is to determine whether a combined nutrition and physical activity education program improves anthropometric measurements, eating behavior, physical activity, and health-related quality of life compared with physical activity education alone or usual care. The findings are expected to provide evidence supporting multidisciplinary educational interventions for improving health outcomes in children with celiac disease and contribute to the development of pediatric lifestyle management strategies.
Interventions
BEHAVIORALNutrition 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.
BEHAVIORALPhysical 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.
Sponsors
Bahçeşehir University
The Scientific and Technological Research Council of Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Masking was not feasible because of the nature of the educational interventions. Participants and investigators were aware of the intervention received, and outcome assessments were performed by the study investigators.
Intervention model description
Participants will be randomly assigned to one of three parallel groups: (1) nutrition education plus physical activity education, (2) physical activity education only, or (3) a control group receiving no education during the intervention period. Participants will remain in their assigned groups throughout the 6-week intervention and follow-up period.
Eligibility
Sex/Gender
ALL
Age
8 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in packaged gluten-free food consumption frequency | Baseline and Week 6 | 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. |
| Change in physical activity level | Baseline and Week 6 | 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. |
| Change in health-related quality of life | Baseline and Week 6 | 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. |
| Change in daily step count | Baseline and Week 6 | 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. |
| Change in body mass index-for-age z-score | Baseline and Week 6 | Body mass index (BMI)-for-age z-score will be calculated according to the World Health Organization growth standards using standardized anthropometric measurements obtained at baseline and Week 6. |
| Change in body fat percentage | Baseline and Week 6 | Body fat percentage will be measured using bioelectrical impedance analysis (InBody 270). Changes from baseline to Week 6 will be compared between the study groups. |
| Change in fat-free mass | Baseline and Week 6 | Fat-free mass will be measured using bioelectrical impedance analysis (InBody 270). Changes from baseline to Week 6 will be compared between the study groups. |
| Change in lower extremity muscle strength | Baseline and Week 6 | Lower extremity muscle strength will be assessed using the 30-Second Chair Stand Test. The total number of completed stands within 30 seconds will be recorded and compared between the study groups. |
| Change in flexibility | Baseline and Week 6 | Flexibility will be assessed using the Sit-and-Reach Test. The maximum reach distance achieved during the test will be recorded and compared between the study groups. |
Countries
Turkey (Türkiye)
Contacts
CONTACTİlayda Altuncevahir, Assistant Professor, PhD
Outcome results
None listed