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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 UMIN000027702
受付番号 R000030148
科学的試験名
一般公開日(本登録希望日) 2017/06/21
最終更新日 2017/06/21

※ 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
CREATING A HEALTHIER NUTRITION ENVIRONMENT IN SCHOOLS: THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
一般向け試験名略称/Acronym
THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
科学的試験名/Scientific Title
CREATING A HEALTHIER NUTRITION ENVIRONMENT IN SCHOOLS: THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
科学的試験名略称/Scientific Title:Acronym
THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
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
Randomized control trial
疾患区分1/Classification by specialty
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 reduce the proportion of energy-dense foods and drinks sold in canteens of selected schools after the intervention
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
1.To improve food choice behavior, nutrition knowledge and nutritional status of school children
2.To improve stakeholders (parents, teachers and canteen operators ) nutrition knowledge, attitudes and practices
3.To investigate predisposing, enabling and reinforcing, epidemiology, behavioral and environmental factors
4.To implement educational and behaviour change strategies in the intervention schools among children and stakeholders.
6.To evaluate process of the intervention programme based on predisposing, enabling and reinforcing factors six month post intervention in both intervention and control group.
7.To asses impact of the intervention on behavioral, environmental factors and sales of energy-dense foods and drinks six month post intervention in both intervention and control group.
試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 第Ⅱ相/Phase II

評価/Assessment
主要アウトカム評価項目/Primary outcomes
reduction in proportion of energy-dense foods and drinks in canteens of selected schools after the intervention
副次アウトカム評価項目/Key secondary outcomes
1. Improvement in food choice behavior, nutritional knowledge and nutritional status of school children

2. Improved stakeholders (parents, teachers and canteen operators ) nutrition knowledge, attitudes and practices

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 試験参加者がブラインド化されている単盲検/Single blind -participants are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 知る必要がない/No need to know

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 教育・カウンセリング・トレーニング/Educational,Counseling,Training
介入の種類/Type of intervention
行動・習慣/Behavior,custom
介入1/Interventions/Control_1
Intervention: The intervention consist of a multi-component diet and nutrition education over a 6-month to one-year period, which will comprise a self-help education module, seminars with audio-visual aids, monthly diet and weight management counseling. Development of the module will be based on the baseline data and the content will be verified by expert panels. New foods with reduced fat and sugar and increased fibre content appropriate for children will be developed and tested for nutritional content, safety and sensory evaluation will be carried out on children parents and canteen operators.

Control: Will received the intervention material after the trial is over
介入2/Interventions/Control_2
Intervention: The intervention consist of a multi-component diet and nutrition education over a 6-month to one-year period, which will comprise a self-help education module, seminars with audio-visual aids, monthly diet and weight management counseling. Development of the module will be based on the baseline data and the content will be verified by expert panels. New foods with reduced fat and sugar and increased fibre content appropriate for children will be developed and tested for nutritional content, safety and sensory evaluation will be carried out on children parents and canteen operators.

Control: Will received the intervention material after the trial is over
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
13 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
17 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
All primary school children from the selected schools with informed consent of the parents are eligible to participate in this study. Parents of selected children, teachers and canteen operators will also be included.

除外基準/Key exclusion criteria
Students in public exam classes
目標参加者数/Target sample size 510

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

ミドルネーム


ミドルネーム
PROF DR MIRNALINI KANDIAH
所属組織/Organization
USCI UNIVERSITY
所属部署/Division name
DEPARTMENT OF FOOD SCIENCE & NUTRITION, FACULTY OF APPLIED SCIENCES
郵便番号/Zip code
住所/Address
NO 1 JALAN MENARA GADING, UCSI HEIGHTS 56000 CHERAS, KUALA LUMPUR, MALAYSIA
電話/TEL 016-6662311
Email/Email mirnalini@ucsiuniversity.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


ミドルネーム
VAIDEHI ULAGANATHAN
組織名/Organization
USCI University
部署名/Division name
DEPARTMENT OF FOOD SCIENCE & NUTRITION, FACULTY OF APPLIED SCIENCES
郵便番号/Zip code
住所/Address
NO 1 JALAN MENARA GADING, UCSI HEIGHTS 56000 CHERAS, KUALA LUMPUR, MALAYSIA
電話/TEL +60102215379
試験のホームページURL/Homepage URL https://www.facebook.com/NuTeen.Malaysia/
Email/Email vaisu_uma10@yahoo.com.my

実施責任組織/Sponsor
機関名/Institute その他 Centre of Excellence for Research, Value Innovation and Entrepreneurship (CERVIE)
Mezzanine Level, 3rd Floor, Block C (Academic Block)
UCSI University
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 MINISTRY OF SCIENCE, TECHNOLOGY AND INNOVATIONOF MALAYSIA (MOSTI)
Fund Secretariat
Planning Division
http://ernd.mosti.gov.my/eScience
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 地方自治体/Local Government
研究費拠出国/Nationality of Funding Organization
MALAYSIAN

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
NONE
その他の研究費提供組織/Name of secondary funder(s)
NONE

IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

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
2017 06 21

関連情報/Related information
プロトコル掲載URL/URL releasing protocol http://www.nutriweb.org.my/publications/mjn0023_1/default.php
試験結果の公開状況/Publication of results 中間解析等の途中公開/Partially published

結果/Result
結果掲載URL/URL related to results and publications http://www.nutriweb.org.my/publications/mjn0023_1/default.php
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results
At baseline 924 students and respective parents, 254 teachers and 40 canteen operators answered the questionnaires. Obesity was found in 32% of students. Vegetable and fruit consumption was below 30% and 60% of students think that foods sold in canteen lack healthy food choices. Nutrition knowledge was low in students and moderate in teachers, parents and canteen staff. Over 40% of canteen food were energy-dense food. Well planned and sustainable interventions should be comprehensive and encompass theoretical models with active student and community involvement
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
2014 09 26
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2015 06 01
フォロー終了(予定)日/Last follow-up date
2017 05 05
入力終了(予定)日/Date of closure to data entry
2017 12 15
データ固定(予定)日/Date trial data considered complete
2017 12 31
解析終了(予定)日/Date analysis concluded
2018 03 15

その他/Other
その他関連情報/Other related information
Total of 1000 students, respective parents and350 teachers was recruited during pre-intervention

Checklist on environment factor developed
- Canteen facilities
- Cleanliness
- Type of food sold and price

管理情報/Management information
登録日時/Registered date
2017 06 09
最終更新日/Last modified on
2017 06 21


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=R000030148
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030148

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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