The Program SI! for Cardiovascular Health Promotion at Elementary School (PSIE)
1 februari 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
1770
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Madrid, Spanje, 28001
- Foundation for Science, Health and Education
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
5 jaar tot 6 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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).
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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.
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.
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Geen tussenkomst: 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.
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Experimenteel: 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).
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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.
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Experimenteel: 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).
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 3-year, and 6-year changes from baseline of questionnaire scoring for children
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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.
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3-year, and 6-year changes from baseline of questionnaire scoring for children
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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.
Tijdsspanne: 3-year, and 6-year changes from baseline on cardiovascular health markers of children
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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).
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3-year, and 6-year changes from baseline on cardiovascular health markers of children
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for families.
Tijdsspanne: 3-year, and 6-year changes from baseline of questionnaire scoring for families
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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).
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3-year, and 6-year changes from baseline of questionnaire scoring for families
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Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for teachers
Tijdsspanne: 3-year, and 6-year changes from baseline of questionnaire scoring for teachers
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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).
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3-year, and 6-year changes from baseline of questionnaire scoring for teachers
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Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for school environment
Tijdsspanne: 3-year, and 6-year changes from baseline of questionnaire scoring for school environment
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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.
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3-year, and 6-year changes from baseline of questionnaire scoring for school environment
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie stoel: Valentín Fuster, MD, PhD, Chairman of the Foundation for Science, Health and Education
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
- Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.
- Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
- Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.
- Sotos-Prieto M, Moreno-Franco B, Ordovas JM, Leon M, Casasnovas JA, Penalvo JL. Design and development of an instrument to measure overall lifestyle habits for epidemiological research: the Mediterranean Lifestyle (MEDLIFE) index. Public Health Nutr. 2015 Apr;18(6):959-67. doi: 10.1017/S1368980014001360. Epub 2014 Jul 15.
- Santos-Beneit G, Sotos-Prieto M, Pocock S, Redondo J, Fuster V, Penalvo JL. Association between anthropometry and high blood pressure in a representative sample of preschoolers in madrid. Rev Esp Cardiol (Engl Ed). 2015 Jun;68(6):477-84. doi: 10.1016/j.rec.2014.09.002. Epub 2014 Dec 6.
- Santos-Beneit G, Bodega P, de Miguel M, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, de Cos-Gandoy A, Penalvo JL, Gomez-Pardo E, Oliva B, Ibanez B, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Rationale and design of the SI! Program for health promotion in elementary students aged 6 to 11 years: A cluster randomized trial. Am Heart J. 2019 Apr;210:9-17. doi: 10.1016/j.ahj.2018.12.011. Epub 2019 Jan 8.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2014
Primaire voltooiing (Werkelijk)
1 juni 2020
Studie voltooiing (Werkelijk)
1 juni 2020
Studieregistratiedata
Eerst ingediend
8 april 2015
Eerst ingediend dat voldeed aan de QC-criteria
23 april 2015
Eerst geplaatst (Schatting)
29 april 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 februari 2021
Laatste update ingediend die voldeed aan QC-criteria
1 februari 2021
Laatst geverifieerd
1 februari 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SHE-002-SI
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