The SI! Program Reintervention for Elementary Schools Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorFoundation for Science, Health and Education, Spain
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Late intervention
Behavioral* SI! Program environment intervention from 5th grade through all Elementary Education. * SI! Program classroom intervention in 5th grade.
Treatment groups
840 Participants
are divided into 2 treatment groupsGroup A: ReinterventionActive comparator 1 intervention
Group B: Late interventionActive comparator 1 intervention
Trial outcomes
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).
Time frame
From baseline assessment to the end of the intervention, an average of 5 yearsSecondary outcomes
1
Effect of the SI! Program reintervention in the individual components of the SI!-Child health score
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)).
Time frame
From baseline assessment to the end of the intervention, an average of 5 yearsOther outcomes
1
Effect of the SI! Program reintervention in sedentary time
Mean and change in minutes of sedentary time assessed with a wrist-worn Actigraph wGT3X-BT accelerometer.
Time frame
From baseline assessment to the end of the intervention, an average of 5 years2
Effect of the SI! Program reintervention in screen time
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.
Time frame
From baseline assessment to the end of the intervention, an average of 5 years3
Effect of the SI! Program reintervention in tobacco exposure
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).
Time frame
From baseline assessment to the end of the intervention, an average of 5 years4
Effect of the SI! Program reintervention in body mass index
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.
Time frame
From baseline assessment to the end of the intervention, an average of 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Foundation for Science, Health and Education, Spain
Lead sponsor
La Caixa Foundation
Collaborator
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Collaborator
Source ClinicalTrials.gov