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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000039773
受付番号 R000045358
科学的試験名
一般公開日(本登録希望日) 2020/03/11
最終更新日 2020/03/11

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Evaluation of a community-based football-driven nutrition education program among primary school children
一般向け試験名略称/Acronym
Community-based football-driven nutrition education program among primary school children
科学的試験名/Scientific Title
Evaluation of a community-based football-driven nutrition education program among primary school children
科学的試験名略称/Scientific Title:Acronym
Community-based football-driven nutrition education program among primary school children
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Malnutrition, overweight, obesity, stunted and underweight
疾患区分1/Classification by specialty
該当せず/Not applicable 小児/Child
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To evaluate the effectiveness of a community-based football-driven nutrition education program among primary school children
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
1.To determine the socio-demographic background of the primary school children at baseline.
2.To evaluate the implementation process of the intervention program (attendance and feedback of the program)
3.To determine and compare the main differences in:
(i) Nutrition knowledge, attitude, and practice (KAP),
(ii) Physical activity (physical activity level, aerobic endurance, muscle endurance, lower limb muscle strength, flexibility),
(iii) Dietary practices (eating behaviours, meal consumption, meal skipping, snack, family meals and food-away-from-home, food companion, nutrient intake),
(iv) Body compositions (BMI-for-age, height-for-age, body weight status, body fat percentage, skeletal muscle mass, waist circumference),
(v) Cognitive performance, and
(vi) Health-related quality of life (HRQoL)
between intervention and control groups, before intervention (baseline), after intervention (post-intervention I), and at 3-month follow up (post-intervention II).
試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
(1) Changes in nutrition knowledge, attitude and practice (included physical activity level and dietary practices)
副次アウトカム評価項目/Key secondary outcomes
(1) Changes in physical fitness
(2) Changes in body compositions
(3) Changes in cognitive performance
(4) Changes in health-related quality of life

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 集団/Cluster
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/Interventions/Control_1
The children in the intervention group in the intervention group will be participating in the intervention program which will be educating nutrition and football technique (30 topics) for 1 year period.
介入2/Interventions/Control_2
Children in the control group are not subjected to any intervention until the end of the study period.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
7 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
12 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
1.Male and Female
2.Obtained parents' consent
3.All body weight status
除外基準/Key exclusion criteria
1.Non-Malaysian
2.Any diagnosed physical disability which affect the execution of activities such as limb defects, spinal cord injury or other condition listed by the Department of Social Welfare
3.Any diagnosed mental disability which affect the his or her relationship with the community such as organic mental disorder, depression or other condition listed by Department of Social Welfare
目標参加者数/Target sample size 334

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Yit Siew
ミドルネーム
Chin
所属組織/Organization
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
所属部署/Division name
Department of Nutrition and Dietetics
郵便番号/Zip code 43400
住所/Address
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
電話/TEL +603-89472680
Email/Email chinys@upm.edu.my

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Yit Siew
ミドルネーム
Chin
組織名/Organization
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, UPM
部署名/Division name
Department of Nutrition and Dietetics
郵便番号/Zip code 43400
住所/Address
Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia
電話/TEL +603-89472680
試験のホームページURL/Homepage URL
Email/Email chinys@upm.edu.my

実施責任組織/Sponsor
機関名/Institute その他 Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 WVM Foundation
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
住所/Address
Office of the Deputy Vice Chancellor (Research & Innovation), Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia
電話/Tel +603-97691002
Email/Email tncpi@upm.edu.my

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Faculty of Medicine and Health Sciences, Universiti Putra Malaysia

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 03 11

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 564
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2019 01 01
倫理委員会による承認日/Date of IRB
2019 07 10
登録・組入れ開始(予定)日/Anticipated trial start date
2019 09 01
フォロー終了(予定)日/Last follow-up date
2020 03 08
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 03 11
最終更新日/Last modified on
2020 03 11


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045358
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045358

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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