- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ichen Huang, PhD
- Phone Number: 7523 +886-4-22063366
- Email: yichenhuang@mail.cmu.edu.tw
Study Locations
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-
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Chiayi City, Taiwan, 603003
- Completed
- Danan Elementary School
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Chiayi City, Taiwan, 614006
- Recruiting
- Wengang Elementary School
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Contact:
- School Lunch Executive Secretary
- Phone Number: +886-978501115
- Email: ugps@mail.cyc.edu.tw
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Hsinchu, Taiwan, 313209
- Completed
- Yufeng Elementary School
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Hualien City, Taiwan, 981008
- Completed
- Yudong Junior High School
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Hualien City, Taiwan, 983002
- Completed
- Xuetian Elementary School
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Hualien City, Taiwan, 983004
- Recruiting
- Dongli Junior High School
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Contact:
- School Dietitian
- Phone Number: +886-3-8861174 ext. 26
- Email: jillian0409@hlc.edu.tw
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Kaohsiung City, Taiwan, 851001
- Completed
- Duona Elementary School
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Pingtung City, Taiwan, 943012
- Recruiting
- Danlu Elementary School
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Contact:
- Section Chief of Student Guidance
- Phone Number: +886-980405417
- Email: safety12370@gmail.com
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Taichung, Taiwan, 424123
- Completed
- Pingdeng Elementary School
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Taitung, Taiwan, 952304
- Completed
- Iraraley Elementary School
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Taitung, Taiwan, 953002
- Completed
- Wuling Elementary School
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Taoyuan, Taiwan, 335013
- Recruiting
- Daxi Junior High School
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Contact:
- Section Chief of Physical Education
- Phone Number: +886-968173411
- Email: mengfanhu80411@gmail.com
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Yuanlin, Taiwan, 633103
- Recruiting
- Makuang Junior High School
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Contact:
- School Dietitian
- Phone Number: +886-5-6653587 ext. 016
- Email: p94760@gmail.com
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Yuanlin, Taiwan, 655026
- Recruiting
- Sinsheng Elementary School
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Contact:
- School Nurse
- Phone Number: +886-5-6341224 ext. 071
- Email: liuchiafen1228@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Classroom Concentration Score
Time Frame: Baseline, after one semester, and after one school year
|
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.
|
Baseline, after one semester, and after one school year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary diversity
Time Frame: Baseline, after one semester, and after one school year
|
Dietary diversity will be assessed using the questionnaire.
|
Baseline, after one semester, and after one school year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH114-REC1-123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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