The Effect of Individualized Nutrition Intervention on Nutritional Status, Gastrointestinal Symptoms, and Quality of Life in Children With Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to learn if individualized nutrition support can improve nutrition, gastrointestinal symptoms, and quality of life in children with cerebral palsy.
The main questions it aims to answer are:
Does individualized nutrition support improve the nutrition status of children with cerebral palsy? Does individualized nutrition support improve gastrointestinal symptoms and quality of life?
Researchers will compare children who receive individualized nutrition support with children who receive routine care.
Participants will:
Be randomly placed into one of two groups Have their nutrition status assessed Have their gastrointestinal symptoms and quality of life assessed Receive individualized nutrition support or continue routine care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 12 years diagnosed with cerebral palsy
- •Children classified as Gross Motor Function Classification System (GMFCS) levels I to III
- •Children who are orally fed
- •Children whose parent or legal guardian provides written informed consent
- •Children who are able to complete baseline and follow-up assessments
排除标准
- •Exclusion Criteria:
- •Children who had an acute illness or serious infection within 10 days before being invited to the study
- •Children with a genetic syndrome that may affect nutritional status, such as Silver-Russell syndrome or Down syndrome
- •Children who are not orally fed or who receive enteral or parenteral nutrition support
- •Children who participated in any dietary intervention during the last 3 months
- •Children who received or started any new treatment other than routine physical therapy during the last 3 months, such as botulinum toxin injection, orthopedic surgery, or a new intensive rehabilitation program
- •Children whose parent or legal guardian cannot fully understand the study procedures or does not speak Turkish
- •Children who used any food supplement or vitamin supplement during the last 3 months
- •Children who do not comply with the diet during the intervention or who wish to withdraw from the study
研究组 & 干预措施
Routine Care
Participants in this group will continue to receive routine care during the 8-week study period. Nutritional status, gastrointestinal symptoms, dietary quality, and quality of life will be assessed at baseline and Week 8. No individualized nutrition intervention will be provided to the control group during the study period. After completion of the Week 8 assessments, families in the control group will be provided with feedback and nutrition counseling based on the child's nutritional assessment, if needed.
Individualized Nutrition Intervention
Participants in the intervention group will receive individualized nutrition counseling and dietary recommendations based on nutritional status, dietary intake, anthropometric measurements, gastrointestinal symptoms, and individual needs. The intervention will include assessment of dietary intake, individualized dietary planning, nutrition education, and follow-up during the 8-week study period. No drug, device, or dietary supplement will be administered as part of the intervention.
干预措施: Individualized Nutrition Intervention (Behavioral)
研究者
Beda Büşra ÖZALP ÇOLAK
Research Assistant
Gazi University