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

Foundation for Science, Health and Education, Spain

Status: Enrolling

Conditions: Cardiovascular Health; Obesity

Treatments: Behavioral: Reintervention; Behavioral: Late intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06715358

SHE-004-SI

Details and patient eligibility

About

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.

Enrollment: 840 estimated patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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840 participants in 2 patient groups

Reintervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Reintervention

Late intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Late intervention