The Program SI! for Cardiovascular Health Promotion at Elementary School

NCT02428634 | Completed

• 1 other identifier: SHE-002-SI
• Study Type: interventional
• Target: 1,770
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular health promotion; Children; School intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

Secondary Outcomes (3)

• Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for families.

  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

  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

  3-year, and 6-year changes from baseline of questionnaire scoring for school environment

Study Arms (4)

Program SI! for Elementary 6 levels

EXPERIMENTAL

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).

Behavioral: PSIE13; Behavioral: PSIE46

Normal curriculum

NO INTERVENTION

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.

Program SI! for Elementary first levels

EXPERIMENTAL

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).

Behavioral: PSIE13

Program SI! for Elementary last levels

EXPERIMENTAL

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).

Behavioral: PSIE46

Interventions

PSIE13 BEHAVIORAL

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.

Program SI! for Elementary 6 levels; Program SI! for Elementary first levels

PSIE46 BEHAVIORAL

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.

Program SI! for Elementary 6 levels; Program SI! for Elementary last levels

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Science, Health and Education, Spain: lead
• Fondation Daniel & Nina Carasso: collaborator

Study Sites (1)

Foundation for Science, Health and Education

Madrid, 28001, Spain

Location

Related Publications (7)

• 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.

  PMID: 15482620 BACKGROUND

• 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.

  PMID: 9255702 BACKGROUND

• 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.

  PMID: 25025396 BACKGROUND

• 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.

  PMID: 16673626 BACKGROUND

• 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.

  PMID: 25487220 BACKGROUND

• 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.

  PMID: 34555181 DERIVED

• 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.

  PMID: 30716509 DERIVED

Related Links

• Encuesta Nacional de Salud España 2011/2012
• Program SI! website

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Valentín Fuster, MD, PhD

  Chairman of the Foundation for Science, Health and Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 29, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-02

Locations

ES (1)