Santos‐Beneit 2019.

Study name	The Program SI! for Cardiovascular Health Promotion at Elementary School (PSIE)
Methods	Type of trial: efficacy Allocation: cluster‐randomised Intervention model: parallel assignment Masking: none (open‐label)
Participants	Estimated number of schools:  Estimated number of participants: 1770 Inclusion criteria (schools): Exclusion criteria (schools): Inclusion criteria (students): Exclusion criteria (students):
Interventions	Program SI! The core intervention comprises classroom activities grouped into healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across different levels and implemented by corresponding teachers. All 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  Intervention 1: intervention is implemented during all elementary levels Intervention 2: intervention is implemented during first 3 levels of elementary school Intervention 3: intervention is implemented during last 3 levels of elementary schools  Comparator: schools in control group keep their normal curriculum and do not join any school programme about health until the end of the study
Outcomes	Primary outcomes: knowledge, attitudes, and habits related to diet, physical activity, body and heart and emotion management, cardiovascular health markers (blood pressure, height, weight, waist circumference, and triceps and subscapular skin‐fold thickness) Secondary outcome: family habits, teacher habits, aspects of the school environment Other outcomes: −
Starting date	Trial start date: October 2014 Trial end date: June 2020 (anticipated)
Contact information	Valentín Fuster, MD, PhD
Notes