Individualized Nutrition Intervention in Children With Cerebral Palsy (CP-NUTRI)
17 juni 2026 uppdaterad av: 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
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ankara
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Ankara, Ankara, Turkiet (Türkiye), 06490
- Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Cerebral Palsy Quality of Life Questionnaire for Children Score
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Body Mass Index-for-Age Z-Score
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Bülent ELBASAN, Prof. Dr., Gazi University
- Studierektor: Nilüfer ACAR TEK, Prof. Dr., Gazi University
- Huvudutredare: Beda Büşra ÖZALP ÇOLAK, Gazi University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2026
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
21 maj 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CPGAZIBDB
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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