Individualized Nutrition Intervention in Children With Cerebral Palsy (CP-NUTRI)
17 juin 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ankara
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Ankara, Ankara, Turquie (Türkiye), 06490
- Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune 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.
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Cerebral Palsy Quality of Life Questionnaire for Children Score
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Body Mass Index-for-Age Z-Score
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Bülent ELBASAN, Prof. Dr., Gazi University
- Directeur d'études: Nilüfer ACAR TEK, Prof. Dr., Gazi University
- Chercheur principal: Beda Büşra ÖZALP ÇOLAK, Gazi University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mai 2026
Achèvement primaire (Estimé)
1 septembre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
21 mai 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CPGAZIBDB
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .