Individualized Nutrition Intervention in Children With Cerebral Palsy

NCT07644572 | Enrolling By Invitation

• 1 other identifier: CPGAZIBDB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy; Cerebral Palsy (CP)

Keywords

Diet intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Body Mass Index-for-Age Z-Score

  Baseline and Week 8

• Change in Gastrointestinal Symptoms

  Baseline and Week 8

• Change in Youth Healthy Eating Index Score

  Baseline and Week 8

Study Arms (2)

Routine Care

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

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.

Individualized Nutrition Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)