- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ichen Huang, PhD
- Número de teléfono: 7523 +886-4-22063366
- Correo electrónico: yichenhuang@mail.cmu.edu.tw
Ubicaciones de estudio
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Chiayi City, Taiwán, 603003
- Terminado
- Danan Elementary School
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Chiayi City, Taiwán, 614006
- Reclutamiento
- Wengang Elementary School
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Contacto:
- School Lunch Executive Secretary
- Número de teléfono: +886-978501115
- Correo electrónico: ugps@mail.cyc.edu.tw
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Hsinchu, Taiwán, 313209
- Terminado
- Yufeng Elementary School
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Hualien City, Taiwán, 981008
- Terminado
- Yudong Junior High School
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Hualien City, Taiwán, 983002
- Terminado
- Xuetian Elementary School
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Hualien City, Taiwán, 983004
- Reclutamiento
- Dongli Junior High School
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Contacto:
- School Dietitian
- Número de teléfono: +886-3-8861174 ext. 26
- Correo electrónico: jillian0409@hlc.edu.tw
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Kaohsiung City, Taiwán, 851001
- Terminado
- Duona Elementary School
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Pingtung City, Taiwán, 943012
- Reclutamiento
- Danlu Elementary School
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Contacto:
- Section Chief of Student Guidance
- Número de teléfono: +886-980405417
- Correo electrónico: safety12370@gmail.com
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Taichung, Taiwán, 424123
- Terminado
- Pingdeng Elementary School
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Taitung, Taiwán, 952304
- Terminado
- Iraraley Elementary School
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Taitung, Taiwán, 953002
- Terminado
- Wuling Elementary School
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Taoyuan, Taiwán, 335013
- Reclutamiento
- Daxi Junior High School
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Contacto:
- Section Chief of Physical Education
- Número de teléfono: +886-968173411
- Correo electrónico: mengfanhu80411@gmail.com
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Yuanlin, Taiwán, 633103
- Reclutamiento
- Makuang Junior High School
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Contacto:
- School Dietitian
- Número de teléfono: +886-5-6653587 ext. 016
- Correo electrónico: p94760@gmail.com
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Yuanlin, Taiwán, 655026
- Reclutamiento
- Sinsheng Elementary School
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Contacto:
- School Nurse
- Número de teléfono: +886-5-6341224 ext. 071
- Correo electrónico: liuchiafen1228@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Classroom Concentration Score
Periodo de tiempo: Baseline, after one semester, and after one school year
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dietary diversity
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CMUH114-REC1-123
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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