Cerebral Palsy, Cerebral Palsy (CP)
Conditions
Keywords
Diet intervention
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
Interventions
BEHAVIORALIndividualized 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.
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cerebral Palsy Quality of Life Questionnaire for Children Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index-for-Age Z-Score | 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. |
| Change in Gastrointestinal Symptoms | 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. |
| Change in Youth Healthy Eating Index Score | 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORNilüfer ACAR TEK, Prof. Dr.
Gazi University
STUDY_CHAIRBülent ELBASAN, Prof. Dr.
Gazi University
PRINCIPAL_INVESTIGATORBeda Büşra ÖZALP ÇOLAK
Gazi University
Outcome results
None listed