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The Program SI! for Cardiovascular Health Promotion at Elementary School (PSIE)

1 de fevereiro de 2021 atualizado por: Foundation for Science, Health and Education, Spain

The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial

The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The Program SI! is a multilevel school-based intervention integrating four cardiovascular health-related components (diet, physical activity, human body and emotions management). Since the Program SI! for preschoolers has shown good results in improving healthy lifestyle habits in children aged 3 to 5 years, the investigators have developed the Program SI! for Elementary addressed to children from 6 to 11 years. The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers, parents and school). In the Community of Madrid-South Area (Spain), 48 public schools from were randomly assigned to Program SI! for Elementary during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, and the secondary outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of their parents and teachers in regards to a healthy lifestyle, as well as changes in the school environment. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry (weight, height, waist circumference and skinfold thickness). The Program SI! for Elementary is designed for different exposures in a sample of schools never intervened to asses when the intervention has the most effectiveness. Besides, as some schools involved in the preschool study continues the Program SI! for Elementary, the investigators can be able to evaluate the impact of the Program SI! in different school stages, concluding how children keep the adoption of healthy behaviors from early in life.

Tipo de estudo

Intervencional

Inscrição (Real)

1770

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Espanha
      • Madrid, Espanha, 28001
        • Foundation for Science, Health and Education

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

5 anos a 6 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Children from public schools with canteen services located in the South Madrid Area of Education, having from 1st to 6th grades and at least two classrooms in 1st grade.

Exclusion Criteria:

  • The coordination team of the SHE Foundation establishes the adherence criteria and the schools not reaching the minimum considered can be excluded. Questionnaires scoring from students with special educational needs will be excluded from the analysis of questionnaires, as well as repeat students.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Program SI! for Elementary 6 levels
The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. The intervention is implemented during all the elementary levels (PSIE13+PSIE46).
Comportamental: PSIE13
The Program SI! is implemented from 1st to 3rd grade of Elementary. A total of 40 hours of intervention on 1st and 2nd grade and 30 hours on 3rd grade has been established as the minimum intervention per year.
Comportamental: PSIE46
The Program SI! is implemented from 4th to 6th grade of Elementary. A total of 30 hours of intervention has been established as the minimum intervention per year.
Sem intervenção: Normal curriculum
The schools on the control group keep their normal curriculum and don't join any school program about health until the end of the study.
Experimental: Program SI! for Elementary first levels
The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the first three levels (PSIE13).
Comportamental: PSIE13
The Program SI! is implemented from 1st to 3rd grade of Elementary. A total of 40 hours of intervention on 1st and 2nd grade and 30 hours on 3rd grade has been established as the minimum intervention per year.
Experimental: Program SI! for Elementary last levels
The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the last three levels (PSIE46).
Comportamental: PSIE46
The Program SI! is implemented from 4th to 6th grade of Elementary. A total of 30 hours of intervention has been established as the minimum intervention per year.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children.
Prazo: 3-year, and 6-year changes from baseline of questionnaire scoring for children
To evaluate children's lifestyle we use a specific questionnaire about knowledge, attitudes and habits in relation to the four components of Program SI! for Elementary (diet, physical activity, body and heart, and emotions management) (article under revision). A trained team of psychologist applies the children's questionnaires at the school.
3-year, and 6-year changes from baseline of questionnaire scoring for children
Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention.
Prazo: 3-year, and 6-year changes from baseline on cardiovascular health markers of children
To evaluate the impact of the Program SI! for Elementary in cardiovascular health markers of children blood pressure and some anthropometric parameters are measured (height, weight, waist circumference and triceps and subscapular skinfold thickness) under standardized protocol developed in previous studies (Santos-Beneit et al. 2014).
3-year, and 6-year changes from baseline on cardiovascular health markers of children

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for families.
Prazo: 3-year, and 6-year changes from baseline of questionnaire scoring for families
The family's habits are evaluated through a specific questionnaire related to key messages for families provided by the Program SI! for Elementary and some general questions about tobacco use and health status (article under revision) and stress perception (Remor 2006). Also in the questionnaire for families are included some questions about their son or daughter's habits (Serra-Majem et al 2004, Goodman 1997, Encuesta Nacional de Salud 2011/2012).
3-year, and 6-year changes from baseline of questionnaire scoring for families
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for teachers
Prazo: 3-year, and 6-year changes from baseline of questionnaire scoring for teachers
The lifestyle of the teachers is evaluated measuring adherence to the Mediterranean lifestyle (Sotos-Prieto et al. 2014) and questions about stress perception (Remor 2006).
3-year, and 6-year changes from baseline of questionnaire scoring for teachers
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for school environment
Prazo: 3-year, and 6-year changes from baseline of questionnaire scoring for school environment
The school environment is evaluated through questions related to the recommendations provided in the Program SI! for Elementary intervention as avoid eating commercially prepared baked foods at school.
3-year, and 6-year changes from baseline of questionnaire scoring for school environment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Foundation for Science, Health and Education, Spain

Colaboradores

Fondation Daniel & Nina Carasso

Investigadores

  • Cadeira de estudo: Valentín Fuster, MD, PhD, Chairman of the Foundation for Science, Health and Education

Publicações e links úteis

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Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de outubro de 2014

Conclusão Primária (Real)

1 de junho de 2020

Conclusão do estudo (Real)

1 de junho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

8 de abril de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de abril de 2015

Primeira postagem (Estimativa)

29 de abril de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de fevereiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de fevereiro de 2021

Última verificação

1 de fevereiro de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SHE-002-SI

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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