Effect of Nutrition and Physical Activity Education on Anthropometric Measurements, Eating Behavior, and Quality of Life in Children With Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in eating behavior score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nutrition Education + Physical Activity Education
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.
干预措施: Nutrition Education (Behavioral)
Nutrition Education + Physical Activity Education
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.
干预措施: Physical Activity Education (Behavioral)
Physical Activity Education
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.
干预措施: Physical Activity Education (Behavioral)
Control
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.
结局指标
主要结局
Change in eating behavior score
时间窗: 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.
次要结局
- 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)
- Change in body fat percentage(Baseline and Week 6)
- Change in fat-free mass(Baseline and Week 6)
- Change in lower extremity muscle strength(Baseline and Week 6)
- Change in flexibility(Baseline and Week 6)
研究者
Ilayda Ozturk Altuncevahir
Asst. Prof.
Bahçeşehir University