Classroom ConcentrationNCT07783646
Evaluation of the Effectiveness of Nutritional Supplement Packages on Improving School Children's Hunger, Eating Behavior and Classroom Concentration
A study testing Nutritional Supplement Pack in people with Classroom Concentration and Dietary Diversity, run by China Medical University Hospital at 14 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Classroom Concentration, Dietary Diversity, Hunger
- What is being tested?
- Nutritional Supplement Pack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 14 sitesTaiwan
- Study dates
- 2 Sep 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students in grades 3-9 who are eligible to receive nutritional supplement packs
Who cannot join
- Students who do not provide assent or whose parent or legal guardian does not provide informed consent.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Taiwan14 sites, 6 recruiting
- Completed
Danan Elementary School
Chiayi City, 603003
- Recruiting
Wengang Elementary School
Chiayi City, 614006
School Lunch Executive Secretary, +886-978501115, ugps@mail.cyc.edu.tw
- Completed
Yufeng Elementary School
Hsinchu, 313209
- Completed
Yudong Junior High School
Hualien City, 981008
- Completed
Xuetian Elementary School
Hualien City, 983002
- Recruiting
Dongli Junior High School
Hualien City, 983004
School Dietitian, +886-3-8861174 ext. 26, jillian0409@hlc.edu.tw
- Completed
Duona Elementary School
Kaohsiung City, 851001
- Recruiting
Danlu Elementary School
Pingtung City, 943012
Section Chief of Student Guidance, +886-980405417, safety12370@gmail.com
- Completed
Pingdeng Elementary School
Taichung, 424123
- Completed
Iraraley Elementary School
Taitung, 952304
- Completed
Wuling Elementary School
Taitung, 953002
- Recruiting
Daxi Junior High School
Taoyuan, 335013
Section Chief of Physical Education, +886-968173411, mengfanhu80411@gmail.com
- Recruiting
Makuang Junior High School
Yuanlin, 633103
School Dietitian, +886-5-6653587 ext. 016, p94760@gmail.com
- Recruiting
Sinsheng Elementary School
Yuanlin, 655026
School Nurse, +886-5-6341224 ext. 071, liuchiafen1228@gmail.com
About this study
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?
Read the 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.
- Conditions
- Classroom Concentration, Dietary Diversity, Hunger
- Being tested
- Nutritional Supplement Pack
- Keywords
- Nutritional supplement packages, Food security, Eating behavior, Cognitive performance
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Supplement PackDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement Pack Group | Experimental | 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. Receives: Dietary Supplement: Nutritional Supplement Pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Classroom Concentration Score
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.
Measured: Baseline, after one semester, and after one school year
Secondary outcomes (1)
Dietary diversity
Dietary diversity will be assessed using the questionnaire. The total score ranges from 0 to 6, with higher scores indicating better dietary diversity.
Measured: Baseline, after one semester, and after one school year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start2 Sep 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classroom ConcentrationStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783646
- Sponsor's protocol ID
- CMUH114-REC1-123
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the personal privacy issue
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Nutritional Supplement Packages on Improving School Children's Hunger, Eating Behavior and Classroom Concentration
- ClinicalTrials.gov ID
- NCT07783646
- Acronym / sponsor ID
- CMUH114-REC1-123
- Conditions
- Classroom Concentration, Dietary Diversity, Hunger
- Keywords
- Nutritional supplement packages, Food security, Eating behavior, Cognitive performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement Pack Group | Experimental | Dietary Supplement: Nutritional Supplement PackParticipants 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. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students in grades 3-9 who are eligible to receive nutritional supplement packs
Key exclusion criteria (1 listed)
- Students who do not provide assent or whose parent or legal guardian does not provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Supplement PackNutritional 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. | Dietary supplement | Nutritional Supplement Pack Group |
Primary outcome
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.
1 secondary outcome
Dietary diversity
Time frame: Baseline, after one semester, and after one school year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Due to the personal privacy issue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement Pack in people with Classroom Concentration and Dietary Diversity, run by China Medical University Hospital at 14 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ichen Huang, PhD (+886-4-22063366 ext. 7523, yichenhuang@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Classroom Concentration Score (time frame: Baseline, after one semester, and after one school year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.