Individualized Nutrition Intervention in Children With Cerebral Palsy (CP-NUTRI)

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cerebral Palsy; Cerebral Palsy (CP)
• Intervention / Treatment: Behavioral: Individualized Nutrition Intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06490
      • Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cerebral Palsy Quality of Life Questionnaire for Children Score	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.	Baseline and week-8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index-for-Age Z-Score	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.	Baseline and Week 8
Change in Gastrointestinal Symptoms	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.	Baseline and Week 8
Change in Youth Healthy Eating Index Score	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.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Diet intervention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: CPGAZIBDB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves children and sensitive health-related data. Study results may be shared in aggregate form through publications or academic presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No