title: A cluster randomized trial to evaluate the efficacy of a school-based behavioral intervention for health promotion among children aged 3 to 5.
abstract: BACKGROUND
  The onset of inadequate behaviors leading to the development of risk factors for chronic diseases is known to occur early in life. An effective program for health promotion should therefore focus on children and their environment, as the starting point for behavior development. The overarching objective of the Program SI! (Salud Integral - Comprehensive Health) is to intervene at the school level, to establish and develop life-lasting habits that will help preserving health during adulthood. The Program SI! comprises five consecutive subprograms according to the five stages of education in Spain, the first being in preschoolers. This study aims to evaluate the efficacy of Program SI! to establish and improve lifestyle behaviors in children (preschoolers aged 3-5 years), their parents, and teachers, and also improving the school environment. A secondary objective is to evaluate improvements in cardiovascular health-related markers (anthropometric parameters, blood pressure, and dietary and physical activity patterns) in these same children.
  
  
  METHODS
  24 public schools from the city of Madrid (Spain) were allocated through stratified randomization to intervention or control. The intervention schools follow the Program SI!, which provides didactic units, emotions cards, healthy tips, and online resources. The intervention schools integrate the Program SI! into their scholar curriculum organized in four complete weeks during each academic year during the 3 years of preschool education. Control schools follow their normal curriculum. Primary outcomes are 1-year, and 3-year changes from baseline of scores for knowledge, attitudes, and habits (KAH) of children, their parents and teachers in regards to a healthy lifestyle. Secondary outcomes are 1-year, and 3-year changes from baseline in clinical and anthropometric parameters of children.
  
  
  CONCLUSIONS
  The Program SI! is a long-term health promotion program starting in 3 years old. It incorporates the traditional areas of intervention (diet and physical activity), introducing additional components such as knowledge of the human body and management of emotions to achieve a comprehensive intervention. The Program SI! is designed to be an effective, sustainable health promotion program for the adoption of healthy behaviors from early in life.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  NCT01579708.
authors.affiliation: Department of Epidemiology, Atherothrombosis and Imaging, Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, 28029, Spain. jlpenalvo@cnic.es.
authors.forename: José L
authors.initials: JL
authors.lastname: Peñalvo
authors.forename: Gloria
authors.initials: G
authors.lastname: Santos-Beneit
authors.forename: Mercedes
authors.initials: M
authors.lastname: Sotos-Prieto
authors.forename: Ramona
authors.initials: R
authors.lastname: Martínez
authors.forename: Carla
authors.initials: C
authors.lastname: Rodríguez
authors.forename: Manuel
authors.initials: M
authors.lastname: Franco
authors.forename: Pedro
authors.initials: P
authors.lastname: López-Romero
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.forename: Juliana
authors.initials: J
authors.lastname: Redondo
authors.forename: Valentín
authors.initials: V
authors.lastname: Fuster
mesh_terms: D000328:Adult; D000886:Anthropometry; D001521:Behavior Therapy; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D002675:Child, Preschool; D003479:Curriculum; D004032:Diet; D004644:Emotions; D015444:Exercise; D005247:Feeding Behavior; D005260:Female; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D008297:Male; D009765:Obesity / Q000209:etiology / Q000517:prevention & control*; D010290:Parents / Q000193:education; D015397:Program Evaluation; D012307:Risk Factors; D012572:School Health Services; D012574:Schools; D013030:Spain