Nutrition and Physical Activity Education in Children With Celiac Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Change in eating behavior score [Срок оценки: Baseline and week 6]

Вторичные конечные точки (9)

• Change in packaged gluten-free food consumption frequency [Срок оценки: Baseline and Week 6]
• Change in physical activity level [Срок оценки: Baseline and Week 6]
• Change in health-related quality of life [Срок оценки: Baseline and Week 6]
• Change in daily step count [Срок оценки: Baseline and Week 6]
• Change in body mass index-for-age z-score [Срок оценки: Baseline and Week 6]
• Change in body fat percentage [Срок оценки: Baseline and Week 6]
• Change in fat-free mass [Срок оценки: Baseline and Week 6]
• Change in lower extremity muscle strength [Срок оценки: Baseline and Week 6]
• Change in flexibility [Срок оценки: Baseline and Week 6]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Bahcesehir University — Istanbul

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07750795 · E-85646034-604.01-113497 · 425S520

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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