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UMIN-CTR 臨床試験登録情報の閲覧 |
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用語の説明（簡易版） |
用語の説明（詳細版）--準備中 |
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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 |
| 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 |
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| 対象疾患/Condition | |||
| 対象疾患名/Condition | Randomized control trial | ||
| 疾患区分1/Classification by specialty |
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| 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. |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 年齢（上限）/Age-upper limit |
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| 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.
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| 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 |
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| 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 |
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| 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） |
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| 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） |
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| 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 |
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| 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 |
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| 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 |
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| フォロー終了(予定)日/Last follow-up date |
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| 入力終了(予定)日/Date of closure to data entry |
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| データ固定（予定）日/Date trial data considered complete |
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| 解析終了(予定)日/Date analysis concluded |
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| 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 |
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| 管理情報/Management information | ||||||||
| 登録日時/Registered date |
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| 最終更新日/Last modified on |
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| 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 |
