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Individualized Nutrition Intervention in Children With Cerebral Palsy (CP-NUTRI)

8. juni 2026 opdateret af: 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

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Ankara
      • Ankara, Ankara, Tyrkiet (Türkiye), 06490
        • Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Cerebral Palsy Quality of Life Questionnaire for Children Score
Tidsramme: 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.
Baseline and week-8

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Mass Index-for-Age Z-Score
Tidsramme: 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.
Baseline and Week 8
Change in Gastrointestinal Symptoms
Tidsramme: 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.
Baseline and Week 8
Change in Youth Healthy Eating Index Score
Tidsramme: 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.
Baseline and Week 8

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gazi University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CPGAZIBDB

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cerebral Parese

Kliniske forsøg med Individualized Nutrition Intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lithuania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner