Individualized Nutrition Intervention in Children With Cerebral Palsy (CP-NUTRI)
2026年6月8日 更新者：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
調査の概要
研究の種類
介入
入学 (推定)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ankara
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Ankara、Ankara、トルコ（Türkiye）、06490
- Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Cerebral Palsy Quality of Life Questionnaire for Children Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Body Mass Index-for-Age Z-Score
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年12月31日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Individualized Nutrition Interventionの臨床試験
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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University of MichiganNational Institute on Drug Abuse (NIDA)完了