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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 UMIN000032914
受付番号 R000037525
試験名
一般公開日(本登録希望日) 2018/06/07
最終更新日 2018/06/07

※ 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
試験名/Official scientific title of the study
Evaluation of Healthy Lifestyle Program for primary school children in Batu Pahat District, Johor State, Malaysia
試験簡略名/Title of the study (Brief title)
Healthy Lifestyle Program (HLP) for 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 and obesity
疾患区分1/Classification by specialty
該当せず/Not applicable
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 Healthy Lifestyle Program among primary school children in Batu Pahat district, Johor.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
1. To determine socio-demographic background among primary school children at baseline.
2. To determine the effectiveness of the Healthy Lifestyle Program in
i) nutrition knowledge, attitude and practices
ii) physical activity
iii) dietary practices (dietary intake and eating behaviour)
iv) sleep behaviour
v) psychological distress (depression, anxiety and stress)
vi) body composition (body weight status, waist circumference and body fat percent)
vii) cognitive performance
viii) health-related quality of life (HRQoL)
between intervention and control groups before and after the intervention program.
3. To determine the changes of school staff nutrition knowledge, attitude and practices between intervention and control group before and after the intervention program.
4. To determine the changes of canteen staff nutrition knowledge among intervention group before and after the intervention program.
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 of BMI-for-Age
2) Changes of nutrition knowledge, attitude and practice
3) Changes of physical activity
4) Changes of eating behaviour
副次アウトカム評価項目/Key secondary outcomes
1) Changes of Psychosocial distress
2) Changes of Cognitive performance
3) Changes of 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 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
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
In the intervention group, children will attend three comprehensive nutrition and health modules (17 topics) through Healthy Kids Camps and continue with three month school meal during recess in school canteen. This program implemented for three months.
介入2/Interventions/Control_2
Children in comparison group were not subjected to the intervention until the end of the period of study. Children in the comparison group attend a standard physical and health education class at least once a week.
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
11 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Male and Female (aged 7 to 11, respectively) and have consent from parents.
除外基準/Key exclusion criteria
-Students with obvious genetic disorders, such as down syndrome and attention deficit hyperactivity disorder (ADHD).
-Children at Standard 6
-Children with learning disorder
目標参加者数/Target sample size 696

責任研究者/Research contact person
責任研究者名/Name of lead principal investigator
Chin Yit Siew
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
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名/Name of contact person
Chin Yit Siew
組織名/Organization
Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
部署名/Division name
Department of Nutrition and Dietetics
住所/Address
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, UPM
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 self-funding
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 自己調達/Self funding
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)


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

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
2018 06 07

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
2018 06 07
登録・組入れ開始(予定)日/Anticipated trial start date
2018 06 07
フォロー終了(予定)日/Last follow-up date
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

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
結果掲載URL/URL releasing results
主な結果/Results

その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 06 07
最終更新日/Last modified on
2018 06 07


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=R000037525
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037525

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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