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Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial.

Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Centro de Investigación Biomédica En Red en enfermedades CardioVasculares (CIBERCV), Madrid, Spain; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, United States. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Foundation for Science, Health and Education (SHE), Barcelona, Spain. Human Nutrition Unit, University Hospital of Sant Joan de Reus, Department of Biochemistry and Biotechnology, Faculty of Medicine and Health Sciences, Pere Virgili Health Research Center, Universitat Rovira i Virgili, Reus, Spain; Biomedical Research Networking Center-Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Government of Spain, Madrid, Spain. Foundation for Science, Health and Education (SHE), Barcelona, Spain. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Centro de Investigación Biomédica En Red en enfermedades CardioVasculares (CIBERCV), Madrid, Spain; IIS-Fundación Jiménez Díaz Hospital, Madrid, Spain. Biomedical Research Networking Center-Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Government of Spain, Madrid, Spain; Department of Nutrition, Food Science and Gastronomy, School of Pharmacy and Food Sciences, XaRTA, INSA, University of Barcelona, Barcelona, Spain. Biomedical Research Networking Center-Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Government of Spain, Madrid, Spain; Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Biomedical Research Networking Center-Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Government of Spain, Madrid, Spain; Department of Nutrition, Food Science and Gastronomy, School of Pharmacy and Food Sciences, XaRTA, INSA, University of Barcelona, Barcelona, Spain. Electronic address: lamuela@ub.edu. Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, United States. Electronic address: vfuster@cnic.es.

American heart journal. 2019;:27-40
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Abstract

UNLABELLED Unhealthy habits in adolescents are increasing at an alarming rate. The school offers a promising environment in which to implement effective preventive strategies to improve adolescents' lifestyle behaviors. The SI! Program is a multilevel multicomponent school-based health-promotion intervention aimed at all stages of compulsory education in Spain. We present the study design of the SI! Program for Secondary Schools, targeting adolescents aged 12 to 16 years. AIM: The main goal of this study is to evaluate the impact of the SI! Program educational intervention on adolescent lifestyle behaviors and health parameters. METHODS The study was designed as a cluster-randomized controlled intervention trial and enrolled 1326 adolescents from 24 public secondary schools in Spain, together with their parents/caregivers. Schools and their students were randomly assigned to the intervention group (the SI! curriculum-based educational program over 2 or 4 academic years) or to the control group (usual curriculum). The primary endpoint will be the change from baseline at 2-year and 4-year follow-up in the composite Ideal Cardiovascular Health (ICH) score, consisting of four health behaviors (body mass index, dietary habits, physical activity, and smoking) and three health factors (blood pressure, total cholesterol, and glucose). Secondary endpoints will include 2-year and 4-year changes from baseline in ICH score subcomponents, the Fuster-BEWAT health scale, adiposity markers (waist circumference and body composition), polyphenol and carotenoid intake, and emotion management. DISCUSSION The overarching goal of the SI! Program is to instill healthy behaviors in children and adolescents that can be sustained into adulthood. The SI! Program for Secondary School is a comprehensive health-promotion intervention targeting 12-16-year-old adolescents and their immediate environment. The present study addresses the optimal timing and impact of the educational intervention on health in adolescence.

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