- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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?
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ichen Huang, PhD
- Numer telefonu: 7523 +886-4-22063366
- E-mail: yichenhuang@mail.cmu.edu.tw
Lokalizacje studiów
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-
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Chiayi City, Tajwan, 603003
- Zakończony
- Danan Elementary School
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Chiayi City, Tajwan, 614006
- Rekrutacyjny
- Wengang Elementary School
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Kontakt:
- School Lunch Executive Secretary
- Numer telefonu: +886-978501115
- E-mail: ugps@mail.cyc.edu.tw
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Hsinchu, Tajwan, 313209
- Zakończony
- Yufeng Elementary School
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Hualien City, Tajwan, 981008
- Zakończony
- Yudong Junior High School
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Hualien City, Tajwan, 983002
- Zakończony
- Xuetian Elementary School
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Hualien City, Tajwan, 983004
- Rekrutacyjny
- Dongli Junior High School
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Kontakt:
- School Dietitian
- Numer telefonu: +886-3-8861174 ext. 26
- E-mail: jillian0409@hlc.edu.tw
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Kaohsiung City, Tajwan, 851001
- Zakończony
- Duona Elementary School
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Pingtung City, Tajwan, 943012
- Rekrutacyjny
- Danlu Elementary School
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Kontakt:
- Section Chief of Student Guidance
- Numer telefonu: +886-980405417
- E-mail: safety12370@gmail.com
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Taichung, Tajwan, 424123
- Zakończony
- Pingdeng Elementary School
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Taitung, Tajwan, 952304
- Zakończony
- Iraraley Elementary School
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Taitung, Tajwan, 953002
- Zakończony
- Wuling Elementary School
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Taoyuan, Tajwan, 335013
- Rekrutacyjny
- Daxi Junior High School
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Kontakt:
- Section Chief of Physical Education
- Numer telefonu: +886-968173411
- E-mail: mengfanhu80411@gmail.com
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Yuanlin, Tajwan, 633103
- Rekrutacyjny
- Makuang Junior High School
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Kontakt:
- School Dietitian
- Numer telefonu: +886-5-6653587 ext. 016
- E-mail: p94760@gmail.com
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Yuanlin, Tajwan, 655026
- Rekrutacyjny
- Sinsheng Elementary School
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Kontakt:
- School Nurse
- Numer telefonu: +886-5-6341224 ext. 071
- E-mail: liuchiafen1228@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Classroom Concentration Score
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Dietary diversity
Ramy czasowe: 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.
|
Baseline, after one semester, and after one school year
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CMUH114-REC1-123
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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