- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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?
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ichen Huang, PhD
- Numero di telefono: 7523 +886-4-22063366
- Email: yichenhuang@mail.cmu.edu.tw
Luoghi di studio
-
-
-
Chiayi City, Taiwan, 603003
- Completato
- Danan Elementary School
-
Chiayi City, Taiwan, 614006
- Reclutamento
- Wengang Elementary School
-
Contatto:
- School Lunch Executive Secretary
- Numero di telefono: +886-978501115
- Email: ugps@mail.cyc.edu.tw
-
Hsinchu, Taiwan, 313209
- Completato
- Yufeng Elementary School
-
Hualien City, Taiwan, 981008
- Completato
- Yudong Junior High School
-
Hualien City, Taiwan, 983002
- Completato
- Xuetian Elementary School
-
Hualien City, Taiwan, 983004
- Reclutamento
- Dongli Junior High School
-
Contatto:
- School Dietitian
- Numero di telefono: +886-3-8861174 ext. 26
- Email: jillian0409@hlc.edu.tw
-
Kaohsiung City, Taiwan, 851001
- Completato
- Duona Elementary School
-
Pingtung City, Taiwan, 943012
- Reclutamento
- Danlu Elementary School
-
Contatto:
- Section Chief of Student Guidance
- Numero di telefono: +886-980405417
- Email: safety12370@gmail.com
-
Taichung, Taiwan, 424123
- Completato
- Pingdeng Elementary School
-
Taitung, Taiwan, 952304
- Completato
- Iraraley Elementary School
-
Taitung, Taiwan, 953002
- Completato
- Wuling Elementary School
-
Taoyuan, Taiwan, 335013
- Reclutamento
- Daxi Junior High School
-
Contatto:
- Section Chief of Physical Education
- Numero di telefono: +886-968173411
- Email: mengfanhu80411@gmail.com
-
Yuanlin, Taiwan, 633103
- Reclutamento
- Makuang Junior High School
-
Contatto:
- School Dietitian
- Numero di telefono: +886-5-6653587 ext. 016
- Email: p94760@gmail.com
-
Yuanlin, Taiwan, 655026
- Reclutamento
- Sinsheng Elementary School
-
Contatto:
- School Nurse
- Numero di telefono: +886-5-6341224 ext. 071
- Email: liuchiafen1228@gmail.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Classroom Concentration Score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dietary diversity
Lasso di tempo: 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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CMUH114-REC1-123
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .