Nutrition and Physical Activity Education in Children With Celiac Disease

NCT07750795 | Recruiting

• 2 other identifiers: E-85646034-604.01-113497425S520
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease; Celiac Disease in Children; Celiac Disease in Adolescents

Outcome Measures

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.

  Baseline and week 6

Secondary Outcomes (9)

• Change in packaged gluten-free food consumption frequency

  Baseline and Week 6

• Change in physical activity level

  Baseline and Week 6

• Change in health-related quality of life

  Baseline and Week 6

• Change in daily step count

  Baseline and Week 6

• Change in body mass index-for-age z-score

  Baseline and Week 6

Study Arms (3)

Nutrition Education + Physical Activity Education

EXPERIMENTAL

Participants assigned to this group will receive a structured nutrition education session and a physical activity education program. Nutrition education will focus on healthy gluten-free dietary practices, reducing the consumption of packaged and ultra-processed gluten-free foods, preventing cross-contamination, and promoting balanced nutrition. Physical activity education will include supervised instruction on strengthening, aerobic, flexibility, balance, and coordination exercises. Participants will be followed for 6 weeks with weekly online support sessions.

Behavioral: Nutrition Education; Behavioral: Physical Activity Education

Physical Activity Education

EXPERIMENTAL

A structured physical activity education program including supervised instruction on strengthening, aerobic, balance, flexibility, and coordination exercises. Participants will receive educational materials and weekly online follow-up to encourage adherence throughout the 6-week intervention period.

Behavioral: Physical Activity Education

Control

NO INTERVENTION

Participants assigned to the control group will not receive nutrition or physical activity education during the 6-week intervention period. They will complete the same baseline and post-intervention assessments as the intervention groups. After completion of the study, participants who wish to receive the educational program will be offered the intervention.

Interventions

Nutrition Education BEHAVIORAL

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.

Nutrition Education + Physical Activity Education

Physical Activity Education BEHAVIORAL

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.

Nutrition Education + Physical Activity Education; Physical Activity Education

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Any physical disability or medical condition that would limit participation in the physical activity program.

Sponsors & Collaborators

• Bahçeşehir University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Bahcesehir University

Istanbul, Besiktas, 34353, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Martinez-Rodriguez A, Loaiza-Martinez DA, Sanchez-Sanchez J, Rubio-Arias JA, Alacid F, Prats-Moya S, Martinez-Olcina M, Yanez-Sepulveda R, Asencio-Mas N, Marcos-Pardo PJ. Psychological, Physiological, and Physical Effects of Resistance Training and Personalized Diet in Celiac Women. Front Nutr. 2022 Jun 16;9:838364. doi: 10.3389/fnut.2022.838364. eCollection 2022.

  PMID: 35782929 BACKGROUND

• Nestares T, Martin-Masot R, de Teresa C, Bonillo R, Maldonado J, Flor-Alemany M, Aparicio VA. Influence of Mediterranean Diet Adherence and Physical Activity on Bone Health in Celiac Children on a Gluten-Free Diet. Nutrients. 2021 May 13;13(5):1636. doi: 10.3390/nu13051636.

  PMID: 34068001 BACKGROUND

• Suarez-Gonzalez M, Bousono Garcia C, Jimenez Trevino S, Iglesias Cabo T, Diaz Martin JJ. Influence of nutrition education in paediatric coeliac disease: impact of the role of the registered dietitian: a prospective, single-arm intervention study. J Hum Nutr Diet. 2020 Dec;33(6):775-785. doi: 10.1111/jhn.12800. Epub 2020 Aug 12.

  PMID: 32790023 BACKGROUND

• Catassi C, Verdu EF, Bai JC, Lionetti E. Coeliac disease. Lancet. 2022 Jun 25;399(10344):2413-2426. doi: 10.1016/S0140-6736(22)00794-2. Epub 2022 Jun 9.

  PMID: 35691302 BACKGROUND

MeSH Terms

Conditions

Celiac Disease

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

İlayda Altuncevahir, Assistant Professor, PhD

CONTACT

+90 530 110 5045; ilayda.altuncevahir@bau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)