- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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?
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ichen Huang, PhD
- Telefonnummer: 7523 +886-4-22063366
- E-post: yichenhuang@mail.cmu.edu.tw
Studiesteder
-
-
-
Chiayi City, Taiwan, 603003
- Fullført
- Danan Elementary School
-
Chiayi City, Taiwan, 614006
- Rekruttering
- Wengang Elementary School
-
Ta kontakt med:
- School Lunch Executive Secretary
- Telefonnummer: +886-978501115
- E-post: ugps@mail.cyc.edu.tw
-
Hsinchu, Taiwan, 313209
- Fullført
- Yufeng Elementary School
-
Hualien City, Taiwan, 981008
- Fullført
- Yudong Junior High School
-
Hualien City, Taiwan, 983002
- Fullført
- Xuetian Elementary School
-
Hualien City, Taiwan, 983004
- Rekruttering
- Dongli Junior High School
-
Ta kontakt med:
- School Dietitian
- Telefonnummer: +886-3-8861174 ext. 26
- E-post: jillian0409@hlc.edu.tw
-
Kaohsiung City, Taiwan, 851001
- Fullført
- Duona Elementary School
-
Pingtung City, Taiwan, 943012
- Rekruttering
- Danlu Elementary School
-
Ta kontakt med:
- Section Chief of Student Guidance
- Telefonnummer: +886-980405417
- E-post: safety12370@gmail.com
-
Taichung, Taiwan, 424123
- Fullført
- Pingdeng Elementary School
-
Taitung, Taiwan, 952304
- Fullført
- Iraraley Elementary School
-
Taitung, Taiwan, 953002
- Fullført
- Wuling Elementary School
-
Taoyuan, Taiwan, 335013
- Rekruttering
- Daxi Junior High School
-
Ta kontakt med:
- Section Chief of Physical Education
- Telefonnummer: +886-968173411
- E-post: mengfanhu80411@gmail.com
-
Yuanlin, Taiwan, 633103
- Rekruttering
- Makuang Junior High School
-
Ta kontakt med:
- School Dietitian
- Telefonnummer: +886-5-6653587 ext. 016
- E-post: p94760@gmail.com
-
Yuanlin, Taiwan, 655026
- Rekruttering
- Sinsheng Elementary School
-
Ta kontakt med:
- School Nurse
- Telefonnummer: +886-5-6341224 ext. 071
- E-post: liuchiafen1228@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Classroom Concentration Score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dietary diversity
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMUH114-REC1-123
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .