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Enrolling by Invitation

NCT Number: NCT07644572

Individualized Nutrition Intervention in Children With Cerebral Palsy

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy (CP) Nervous System Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit

Ankara, 06490, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Individualized Nutrition Intervention

Behavioral

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.

Primary outcomes

  1. Change in Cerebral Palsy Quality of Life Questionnaire for Children Score

    Time frame: Baseline and week-8

    Quality of life will be assessed using the Cerebral Palsy Quality of Life Questionnaire for Children. Scores range from 0 to 100, with higher scores indicating better quality of life. The change in score from baseline to Week 8 will be compared between the individualized nutrition intervention group and the routine care group.

Secondary outcomes

  1. Change in Body Mass Index-for-Age Z-Score

    Time frame: Baseline and Week 8

    Body mass index-for-age z-score will be calculated using age- and sex-specific reference standards. The change from baseline to Week 8 will be compared between groups.

  2. Change in Gastrointestinal Symptoms

    Time frame: Baseline and Week 8

    Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale. The mean score ranges from 1 to 7, with higher scores indicating more severe gastrointestinal symptoms. The change in mean score from baseline to Week 8 will be compared between the individualized nutrition intervention group and the routine care group.

  3. Change in Youth Healthy Eating Index Score

    Time frame: Baseline and Week 8

    Dietary quality will be assessed using the Youth Healthy Eating Index. The total score ranges from 0 to 100, with higher scores indicating better dietary quality. The change in total score from baseline to Week 8 will be compared between the individualized nutrition intervention group and the routine care group.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Effect of Individualized Nutrition Intervention on Nutritional Status, Gastrointestinal Symptoms, and Quality of Life in Children With Cerebral Palsy: A Randomized Controlled Trial

Acronym: CP-NUTRI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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