- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07783646
Evaluation of the Effectiveness of Nutritional Supplement Packages on Improving School Children's Hunger, Eating Behavior and Classroom Concentration
The goal of this intervention study is to learn whether providing nutritional supplement packs can reduce hunger at school and improve healthy eating behaviors and classroom concentration among students in grades 3-9 attending schools in remote rural areas. The main questions it aims to answer are:
Does receiving nutritional supplement packs reduce hunger at school and improve healthy eating behaviors and classroom concentration after one semester and one school year compared with baseline? Is hunger at school associated with healthy eating behaviors and classroom concentration?
연구 개요
상세 설명
Backgrounds:
Nutritional supplement packs (long life milk, cereals, nuts) are suggested by the Taiwan Nutrition Foundation based on the general lack of intake among people in Taiwan and taking into account the growth of children. The National Food Bank raises funds from companies and distributes them to primary and secondary school children in remote rural areas for use when they are hungry at school. This program has been implemented for almost ten years and recognized by teachers and parents. It is generally believed that hunger in school children may affect their classroom performance, but most research focused only on skipping breakfast. According to actual survey experience, schoolchildren's hunger at school is not only related to whether they have eaten breakfast, but also factors such as eating habits and high activity levels (such as school teams and after physical education classes) outside of meals. Nutritional supplement packs can be provided to students in need immediately by teachers. Aims: This study aims to investigate whether nutritional supplements are effective in improving school children 's hunger, healthy eating behaviors, and classroom concentration.
Methods: The survey subjects are students in grades 3 9 who received nutritional supplement packs. A total of three self-administered questionnaires will be implemented before and after the intervention (one semester and one school year) to assess changes in eating behavior and concentration. The expected number of cases is 6 00 (will be reached within 3 years). After the indicators were quantified, paired t test was used to compare the changes before and after the intervention; linear regression was used to analyze the correlation between hunger at school, healthy eating behavior and classroom concentration. Expected results: Nutritional supplement packs can effectively improve school children's hunger, eating behavior and classroom concentration; school hunger is correlated with eating behavior and classroom concentration.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ichen Huang, PhD
- 전화번호: 7523 +886-4-22063366
- 이메일: yichenhuang@mail.cmu.edu.tw
연구 장소
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Chiayi City, 대만, 603003
- 완전한
- Danan Elementary School
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Chiayi City, 대만, 614006
- 모병
- Wengang Elementary School
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연락하다:
- School Lunch Executive Secretary
- 전화번호: +886-978501115
- 이메일: ugps@mail.cyc.edu.tw
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Hsinchu, 대만, 313209
- 완전한
- Yufeng Elementary School
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Hualien City, 대만, 981008
- 완전한
- Yudong Junior High School
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Hualien City, 대만, 983002
- 완전한
- Xuetian Elementary School
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Hualien City, 대만, 983004
- 모병
- Dongli Junior High School
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연락하다:
- School Dietitian
- 전화번호: +886-3-8861174 ext. 26
- 이메일: jillian0409@hlc.edu.tw
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Kaohsiung City, 대만, 851001
- 완전한
- Duona Elementary School
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Pingtung City, 대만, 943012
- 모병
- Danlu Elementary School
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연락하다:
- Section Chief of Student Guidance
- 전화번호: +886-980405417
- 이메일: safety12370@gmail.com
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Taichung, 대만, 424123
- 완전한
- Pingdeng Elementary School
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Taitung, 대만, 952304
- 완전한
- Iraraley Elementary School
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Taitung, 대만, 953002
- 완전한
- Wuling Elementary School
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Taoyuan, 대만, 335013
- 모병
- Daxi Junior High School
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연락하다:
- Section Chief of Physical Education
- 전화번호: +886-968173411
- 이메일: mengfanhu80411@gmail.com
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Yuanlin, 대만, 633103
- 모병
- Makuang Junior High School
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연락하다:
- School Dietitian
- 전화번호: +886-5-6653587 ext. 016
- 이메일: p94760@gmail.com
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Yuanlin, 대만, 655026
- 모병
- Sinsheng Elementary School
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연락하다:
- School Nurse
- 전화번호: +886-5-6341224 ext. 071
- 이메일: liuchiafen1228@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Students in grades 3-9 who are eligible to receive nutritional supplement packs
Exclusion Criteria:
- Students who do not provide assent or whose parent or legal guardian does not provide informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Nutritional Supplement Pack Group
Participants will receive nutritional supplement packs for consumption when they feel hungry at school.
Outcomes will be assessed at baseline, after one semester, and after one school year.
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Nutritional supplement packs containing shelf-stable milk, cereals, and nuts are provided to participating students for consumption when they feel hungry at school.
The intervention is implemented over one school year.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Classroom Concentration Score
기간: Baseline, after one semester, and after one school year
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Concentration will be assessed using the Classroom concentration scale.
The total score ranges from 19 to 114, with higher scores indicating better classroom concentration.
Changes from baseline will be assessed after one semester and one school year.
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Baseline, after one semester, and after one school year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Dietary diversity
기간: Baseline, after one semester, and after one school year
|
Dietary diversity will be assessed using the questionnaire.
The total score ranges from 0 to 6, with higher scores indicating better dietary diversity.
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Baseline, after one semester, and after one school year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .