Menu
Enrolling by invitation NCT07644572

Individualized Nutrition Intervention in Children With Cerebral Palsy

No phase Interventional Cerebral Palsy Cerebral Palsy (CP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized Nutrition Intervention.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Cerebral Palsy (CP). Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Change in Cerebral Palsy Quality of Life Questionnaire for Children Score [Time frame: Baseline and week-8]
Secondary outcome measures (3)
  • Change in Body Mass Index-for-Age Z-Score [Time frame: Baseline and Week 8]
  • Change in Gastrointestinal Symptoms [Time frame: Baseline and Week 8]
  • Change in Youth Healthy Eating Index Score [Time frame: Baseline and Week 8]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation — Ankara

Identifiers

NCT: NCT07644572 · CPGAZIBDB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗