The SI! Program Reintervention for Elementary Schools Trial

NCT06715358 | Recruiting

• 1 other identifier: SHE-004-SI
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

Background and objectives: The SI! Program is a multilevel school-based intervention that has been previously evaluated in different ages in three countries. Schools were randomized to the SI! Program intervention or the control group, and prior to and after the intervention several questionnaires and direct measures were used to assess changes in lifestyle and cardiovascular health indicators. In the SI! Program for Preschool, children in the intervention group increased significantly more their knowledge, attitudes and habits after 4 months of the implementation of the SI! Program compared to children in the control group. However, until now, results have shown that improvements in cardiovascular health between 3 and 5 years old do not sustain overtime. For this reason, the new project of the SI! Program proposes a reinforcement of the children's environment to boost the effect of the intervention and a reinforcement in the classroom after 2 years to favor the sustainability of the effect. The main objective of this study is to assess the effect of the reintervention of the SI! Program in the SI!-Child health score in Elementary school children (7-12 years old) and compare its effect with a single late exposure to the SI! Program. Methodology: A cluster-randomized trial involving 50 elementary schools in Spain will be carried out. Schools will be 1:1 randomized to either implement the SI! Program from 2nd grade throughout the whole Elementary Education (5 years) with two classroom interventions (one at 2nd grade and one at 5th grade) or to implement the SI! Program from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade. Children in the first year of Elementary education at the beginning of the trial will be recruited. Participants will be evaluated at baseline, and after 3, 5 and 6 years using a battery of measurements on cardiovascular health parameters (anthropometry, bioimpedance, blood analysis, accelerometers, questionnaires). The primary endpoint will be the change in the SI!-Child score after 5 years. The SI! Child score includes sleep, diet, physical activity and nutritional status, and ranges from 0 to 100, with higher scores indicating better cardiovascular profiles. Secondary outcomes include the change in individual components of the SI!-Child score and other cardiovascular health indicators such as sedentarism, tobacco exposure, adiposity, blood pressure, lipid profile and blood glucose, and to assess the effect of the SI! Program reintervention to maintain or improve all cardiovascular health indicators previously mentioned one year after the reintervention. Expected results: The investigators expect to show that a school-based educational intervention with a reinforcement in the classroom after 2 years in addition to a school environment intervention will induce favorable and sustainable lifestyle changes in health behaviors among Spanish children. If successful, this strategy could be widely adopted having a meaningful effect on cardiovascular health promotion.

Conditions

Cardiovascular Health; Obesity

Keywords

Cardiovascular health; Health promotion; School-based intervention; Children

Outcome Measures

Primary Outcomes (1)

• Change in the SI!-Child health score at the end of the intervention

  The primary outcome will be the difference in the SI!-Child score (0-100 points for each component, higher scores indicating healthier habits) between the reintervention group and the late intervention group. The SI! Child score includes Sleep (measured as hours of sleep), Diet (fruits and vegetables, sugared beverages, fast-food, legumes and nuts, sweets and pastries), Physical activity (minutes of moderate and vigorous physical activity), Nutritional status (body mass index calculated as body weight divided by height squared (kg/m2).

  From baseline assessment to the end of the intervention, an average of 5 years

Secondary Outcomes (1)

• Effect of the SI! Program reintervention in the individual components of the SI!-Child health score

  From baseline assessment to the end of the intervention, an average of 5 years

Other Outcomes (8)

• Effect of the SI! Program reintervention in sedentary time

  From baseline assessment to the end of the intervention, an average of 5 years

• Effect of the SI! Program reintervention in screen time

  From baseline assessment to the end of the intervention, an average of 5 years

• Effect of the SI! Program reintervention in tobacco exposure

  From baseline assessment to the end of the intervention, an average of 5 years

Study Arms (2)

Reintervention

ACTIVE COMPARATOR

Implement the SI! Program environment intervention from 2nd grade throughout the whole Elementary Education (5 years) and with two classroom interventions: one at 2nd grade and a reintervention at 5th grade.

Behavioral: Reintervention

Late intervention

ACTIVE COMPARATOR

Implement the SI! Program environment intervention from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade.

Behavioral: Late intervention

Interventions

Reintervention BEHAVIORAL

* SI! Program environment intervention from 2nd grade through all Elementary Education. * SI! Program classroom intervention in 2nd grade. * SI! Program classroom intervention in 5th grade.

Reintervention

Late intervention BEHAVIORAL

* SI! Program environment intervention from 5th grade through all Elementary Education. * SI! Program classroom intervention in 5th grade.

Late intervention

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Schools from the Madrid Region or Catalonia.
• Public or charter schools
• Schools having from 1st to 6th grades and at least one classroom in 1st grade.
• Schools having a canteen
• Children in the 1st grade.

You may not qualify if:

• None

Sponsors & Collaborators

• Foundation for Science, Health and Education, Spain: lead
• La Caixa Foundation: collaborator
• Centro Nacional de Investigaciones Cardiovasculares Carlos III: collaborator

Study Sites (1)

Foundation for Science, Health and Education

Madrid, 28001, Spain

RECRUITING

Related Publications (8)

• Penalvo JL, Sotos-Prieto M, Santos-Beneit G, Pocock S, Redondo J, Fuster V. The Program SI! intervention for enhancing a healthy lifestyle in preschoolers: first results from a cluster randomized trial. BMC Public Health. 2013 Dec 20;13:1208. doi: 10.1186/1471-2458-13-1208.

  PMID: 24359285 BACKGROUND

• Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Martinez R, Rodriguez C, Franco M, Lopez-Romero P, Pocock S, Redondo J, Fuster V. A cluster randomized trial to evaluate the efficacy of a school-based behavioral intervention for health promotion among children aged 3 to 5. BMC Public Health. 2013 Jul 15;13:656. doi: 10.1186/1471-2458-13-656.

  PMID: 23855415 BACKGROUND

• Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Bodega P, Oliva B, Orrit X, Rodriguez C, Fernandez-Alvira JM, Redondo J, Vedanthan R, Bansilal S, Gomez E, Fuster V. The SI! Program for Cardiovascular Health Promotion in Early Childhood: A Cluster-Randomized Trial. J Am Coll Cardiol. 2015 Oct 6;66(14):1525-1534. doi: 10.1016/j.jacc.2015.08.014.

  PMID: 26429075 BACKGROUND

• 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 BACKGROUND

• Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.

  PMID: 31277052 BACKGROUND

• Santos-Beneit G, Fernandez-Jimenez R, de Cos-Gandoy A, Rodriguez C, Carral V, Bodega P, de Miguel M, Orrit X, Haro D, Penalvo JL, Fernandez-Alvira JM, Peyra C, Cespedes JA, Turco A, Hunn M, Jaslow R, Baxter J, Carvajal I, Fuster V. Lessons Learned From 10 Years of Preschool Intervention for Health Promotion: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Jan 25;79(3):283-298. doi: 10.1016/j.jacc.2021.10.046.

  PMID: 35057915 BACKGROUND

• Santos-Beneit G, Fernandez-Alvira JM, Tresserra-Rimbau A, Bodega P, de Cos-Gandoy A, de Miguel M, Ramirez-Garza SL, Laveriano-Santos EP, Arancibia-Riveros C, Carral V, Orrit X, Rodriguez C, Carvajal I, Haro D, Peyra C, Martinez-Gomez J, Alvarez-Benavides A, Estruch R, Lamuela-Raventos RM, Fernandez-Jimenez R, Fuster V. School-Based Cardiovascular Health Promotion in Adolescents: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2023 Sep 1;8(9):816-824. doi: 10.1001/jamacardio.2023.2231.

  PMID: 37531100 BACKGROUND

• Santos-Beneit G, Bodega P, de Cos-Gandoy A, de Miguel M, Rodriguez C, Orrit X, Carral V, Haro D, Carvajal I, Peyra C, Martinez-Gomez J, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Effect of Time-Varying Exposure to School-Based Health Promotion on Adiposity in Childhood. J Am Coll Cardiol. 2024 Aug 6;84(6):499-508. doi: 10.1016/j.jacc.2024.04.065.

  PMID: 39084824 BACKGROUND

Related Links

• Web of the SHE Foundation
• Web of the SI! Program

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valentin Fuster

  Mount Sinaí Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Santos-Beneit, PhD

CONTACT

+34 914 999 255; gsantos@fundacionshe.org

Patricia Bodega

CONTACT

+34 664 760 139; pbodega@fundacionshe.org

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: November 19, 2024
• First Posted: December 4, 2024
• Study Start: October 24, 2023
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 months after publication
• Access Criteria: The de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator. Email: estudio@fundacionshe.org

Locations

ES (1)