Individualized Nutrition Intervention in Children With Cerebral Palsy (CP-NUTRI)
17 juni 2026 bijgewerkt door: Beda Büşra ÖZALP ÇOLAK, Gazi University
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
Studie Overzicht
Toestand
Aanmelden op uitnodiging
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
50
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ankara
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Ankara, Ankara, Turkije (Türkiye), 06490
- Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: 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.
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Experimenteel: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Cerebral Palsy Quality of Life Questionnaire for Children Score
Tijdsspanne: Baseline and week-8
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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.
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Baseline and week-8
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Body Mass Index-for-Age Z-Score
Tijdsspanne: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Gastrointestinal Symptoms
Tijdsspanne: Baseline and Week 8
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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.
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Baseline and Week 8
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Change in Youth Healthy Eating Index Score
Tijdsspanne: Baseline and Week 8
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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.
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Baseline and Week 8
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Bülent ELBASAN, Prof. Dr., Gazi University
- Studie directeur: Nilüfer ACAR TEK, Prof. Dr., Gazi University
- Hoofdonderzoeker: Beda Büşra ÖZALP ÇOLAK, Gazi University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 mei 2026
Primaire voltooiing (Geschat)
1 september 2026
Studie voltooiing (Geschat)
31 december 2026
Studieregistratiedata
Eerst ingediend
21 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 juni 2026
Eerst geplaatst (Werkelijk)
12 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
17 juni 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CPGAZIBDB
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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