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Celiac DiseaseNCT07750795

Nutrition and Physical Activity Education in Children With Celiac Disease

A study testing Nutrition Education and Physical Activity Education in people with Celiac Disease and Celiac Disease in Children, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 12 years
What is being tested?
Nutrition Education and Physical Activity Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2026to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

İlayda Altuncevahir, Assistant Professor, PhD contact

+90 530 110 5045

ilayda.altuncevahir@bau.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Bahcesehir University

    Istanbul, Besiktas, 34353

    İlayda Altuncevahir, Assistant Professor, PhD, +90 212 3810000 ext. 9203, ilayda.altuncevahir@bau.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Nutrition and Physical Activity Education on Anthropometric Measurements, Eating Behavior, and Quality of Life in Children With Celiac Disease

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.

Read the 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.

Being tested
Nutrition Education, Physical Activity Education
Medical subject headings
Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition EducationBehavioural

    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 EducationBehavioural

    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 groups in NCT07750795
Study groupRoleWhat they receive
Nutrition Education + Physical Activity EducationExperimentalParticipants 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.
Receives: Behavioral: Nutrition Education; Behavioral: Physical Activity Education
Physical Activity EducationExperimentalA 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.
Receives: Behavioral: Physical Activity Education
ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and week 6

Secondary outcomes (9)

  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.

    Measured: Baseline and Week 6

  2. 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.

    Measured: Baseline and Week 6

  3. 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.

    Measured: Baseline and Week 6

  4. 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.

    Measured: Baseline and Week 6

  5. Change in body mass index-for-age z-score

    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.

    Measured: Baseline and Week 6

  6. Change in body fat percentage

    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.

    Measured: Baseline and Week 6

  7. Change in fat-free mass

    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.

    Measured: Baseline and Week 6

  8. Change in lower extremity muscle strength

    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.

    Measured: Baseline and Week 6

  9. Change in flexibility

    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.

    Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start1 May 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07750795
Sponsor's protocol ID
E-85646034-604.01-113497
Other IDs
425S520
Status last verified
Aug 2026
First submitted
2 Aug 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35782929

  • 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.

    PubMed 34068001

  • 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.

    PubMed 32790023

  • 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.

    PubMed 35691302

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition Education and Physical Activity Education in people with Celiac Disease and Celiac Disease in Children, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact İlayda Altuncevahir, Assistant Professor, PhD (+90 530 110 5045, ilayda.altuncevahir@bau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in eating behavior score (time frame: Baseline and week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07750795, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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