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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 - 05/08/19

Doi : 10.1016/j.ahj.2019.03.014 
Rodrigo Fernandez-Jimenez, MD, PhD a, b, c, Gloria Santos-Beneit, PhD a, d, Anna Tresserra-Rimbau, PhD e, f, Patricia Bodega, MSc a, d, Mercedes de Miguel, MSc a, d, Amaya de Cos-Gandoy, MSc a, d, Carla Rodríguez, MSc d, Vanesa Carral, PhD d, Xavier Orrit, PhD a, d, Domènech Haro, BSc d, Isabel Carvajal, MSc d, Borja Ibañez, MD, PhD a, b, g, Carolina Storniolo, PhD f, h, Mónica Domènech, MD, PhD f, i, Ramon Estruch, MD, PhD f, i, Juan Miguel Fernández-Alvira, PhD a, Rosa Maria Lamuela-Raventós, PhD f, h, , Valentin Fuster, MD, PhD a, c,
a Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain 
b Centro de Investigación Biomédica En Red en enfermedades CardioVasculares (CIBERCV), Madrid, Spain 
c The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, United States 
d Foundation for Science, Health and Education (SHE), Barcelona, Spain 
e 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 
f Biomedical Research Networking Center-Physiopathology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Government of Spain, Madrid, Spain 
g IIS-Fundación Jiménez Díaz Hospital, Madrid, Spain 
h Department of Nutrition, Food Science and Gastronomy, School of Pharmacy and Food Sciences, XaRTA, INSA, University of Barcelona, Barcelona, Spain 
i Department of Internal Medicine, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain 

Reprint requests: Valentin Fuster, MD, PhD, Centro Nacional de Investigaciones Cardiovasculares (CNIC), Melchor Fernández Almagro, 3. 28029, Madrid, Spain. or Rosa M Lamuela-Raventós, PhD, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA-UB, School of Pharmacy and Food Sciences, University of Barcelona, Barcelona, Spain.Centro Nacional de Investigaciones Cardiovasculares (CNIC), Melchor Fernández Almagro, 3. 28029, Madrid, Spain. or Rosa M Lamuela-Raventós, PhD, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA-UB, School of Pharmacy and Food Sciences, University of BarcelonaBarcelonaSpain

Background

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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Abbreviations : CVD, SI, SHE, FFQ, DEXA, BMI, TC, HDL, LDL, ICH


Mappa


 RCT# NCT03504059.
 Trial registration: ClinicalTrials.gov identifier NCT03504059. Registered (NCT03504059).
 Sources of funding: This study was supported by the Fundació la Marató de TV3 (369/C/2016), the “la Caixa” Foundation (LCF/PR/CE16/10700001), and the SHE Foundation. VF is a recipient of funding from the American Heart Association under grant No 14SFRN20490315. R.F-J is a recipient of funding from the European Union Horizon 2020 Research and Innovation Programme under Marie Skłodowska-Curie grant No 707642. We would like to thank the Ministerio de Ciencia, Innovación y Universidades for supporting the project AGL2016–75329-R; and Generalitat de Catalunya. The CNIC is supported by the Instituto de Salud Carlos III (ISCIII), the Ministerio de Ciencia, Innovación y Universidades (MCNU) and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (SEV-2015-0505).


© 2019  The Authors. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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