The SI! Program Reintervention for Elementary Schools Trial (PSIR)

December 3, 2024 updated by: Foundation for Science, Health and Education, Spain

Cluster Randomized Trial for the SI! Program Reintervention for Elementary Schools

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reintervention
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
  • 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.
Active Comparator: Late intervention
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
  • SI! Program environment intervention from 5th grade through all Elementary Education.
  • SI! Program classroom intervention in 5th grade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the SI!-Child health score at the end of the intervention
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the SI! Program reintervention in the individual components of the SI!-Child health score
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Mean score and change at follow-up visits for each of the individual components of the SI! Child score (0-100 points for each component, higher scores indicating healthier habits): 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the SI! Program reintervention in sedentary time
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Mean and change in minutes of sedentary time assessed with a wrist-worn Actigraph wGT3X-BT accelerometer.
From baseline assessment to the end of the intervention, an average of 5 years
Effect of the SI! Program reintervention in screen time
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Mean and change in hours of screen time assessed with a specific questionnaire asking the number of hours of leisure and non-leisure screen time during the week and during the weekends.
From baseline assessment to the end of the intervention, an average of 5 years
Effect of the SI! Program reintervention in tobacco exposure
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Prevalence and change in tobacco exposure assessed with a direct question asking if anyone who lives with the child smokes (binary variable of yes/no).
From baseline assessment to the end of the intervention, an average of 5 years
Effect of the SI! Program reintervention in body mass index
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Mean and change in body mass index (calculated as body weight divided by height squared (kg/m2)). Body height as measured using a stadiometer (Seca 213). Body weight as measured using the OMRON BF511 electronic scale.
From baseline assessment to the end of the intervention, an average of 5 years
Effect of the SI! Program reintervention in waist circumference
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Mean and change in waist circumference (cm). Waist circumference as measured using a Holtain tape.
From baseline assessment to the end of the intervention, an average of 5 years
Effect of the SI! Program reintervention in blood pressure
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Mean and change in blood pressure (systolic and diastolic) (mmHg) as assessed with a fully automated blood pressure monitor (OMRON M6 monitor).
From baseline assessment to the end of the intervention, an average of 5 years
Effect of the SI! Program reintervention in the lipid profile and blood glucose levels
Time Frame: From baseline assessment to the end of the intervention, an average of 5 years
Mean total, LDL- and HDL-cholesterol (mg/dL), and blood glucose (mg/dL) and change at follow-up visits as evaluated by point-of-care testing. Blood glucose and lipid profile were measured using a CardioCheck Plus device and PTS-Panels test strips in capillary blood sampled with a lancet in fasting status.
From baseline assessment to the end of the intervention, an average of 5 years
Change in the SI!-Child score one year after the intervention
Time Frame: From baseline assessment to the end of the trial, an average of 6 years
Differences one year after the reintervention (~13 years of age) in the SI!-Child score (0-100 points for each component, higher scores indicating healthier habits): 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 trial, an average of 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Science, Health and Education, Spain

Collaborators

La Caixa Foundation
Centro Nacional de Investigaciones Cardiovasculares Carlos III

Investigators

  • Principal Investigator: Valentin Fuster, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHE-004-SI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be available upon request, with the approval of the Steering Committee and the signing of a data exchange agreement.

IPD Sharing Time Frame

9 months after publication

IPD Sharing 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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