title: Rationale and methods of a cluster-randomized controlled trial to promote active and healthy lifestyles among Brazilian students: the "Fortaleça sua Saúde" program.
abstract: BACKGROUND
  Interventions on adolescents' lifestyle are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle are unclear. This paper presents the rationale and methods of an intervention program focused on promoting active and healthy lifestyles (especially physical activity [PA] practice and reducing screen time) among Brazilian students-the Fortaleça sua Saúde program (Portuguese for "strengthen your health").
  
  
  METHODS
  This is a school-based cluster-randomized controlled trial. Three intervention and three control (no intervention) full-time public schools were randomly selected in Fortaleza, northeastern Brazil. Students (n = 1,272) from classes in Grades 7-9 were eligible, and 1,085 (548 in the intervention and 537 in control schools) completed the baseline and follow-up measures. The program duration was approximately four months and took place in 2014. Intervention strategies focused on teacher training, activities on health in the curriculum, active opportunities in the school environment (the availability of equipment for PA), and health education (health materials for students and parents). Data collection was undertaken before and immediately after the intervention. The primary variables included the practice of PA (weekly PA volume, PA behavior change stage and preference for PA during leisure-time) and screen time (TV and computer/video games). Potential intrapersonal, interpersonal and environmental mediators of PA and screen time were evaluated by a standardized questionnaire. Other lifestyle components (e.g., eating habits, substance use), psychological (e.g., self-rated health, body satisfaction) and biological (general and abdominal obesity) aspects, as well as academic performance were also evaluated in the total sample. Depressive symptoms, eating disorders, sleep quality, objectively-measured PA, and sedentary time were evaluated in obese students.
  
  
  CONCLUSIONS
  If effective, this program will contribute to the development of public policies for the promotion of active and healthy lifestyles in youth, especially those from low- and middle-income countries. The main intrapersonal, interpersonal and/or environmental mediators of PA and screen time may also be indicated. Finally, we anticipate that the proposed strategies may be adaptable to public schools and may even be extended to the entire school system.
  
  
  BACKGROUND
  ClinicalTrials.Gov: NCT02439827 . Registration date: May 3, 2015.
authors.affiliation: Department of Physical Education, Research Centre in Physical Activity and Health, Federal University of Santa Catarina, Florianopolis, Brazil. valtercbf@gmail.com.|Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, Porto, Portugal. valtercbf@gmail.com.|Institute of Physical Education and Sports, Research Centre in Physical Activity and Health in School, Federal University of Ceara, Fortaleza, Brazil. valtercbf@gmail.com.
authors.forename: Valter Cordeiro
authors.initials: VC
authors.lastname: Barbosa Filho
authors.affiliation: Department of Physical Education, Research Centre in Physical Activity and Health, Federal University of Santa Catarina, Florianopolis, Brazil. adair.lopes@ufsc.br.
authors.forename: Adair da Silva
authors.initials: Ada S
authors.lastname: Lopes
authors.affiliation: Institute of Physical Education and Sports, Research Centre in Physical Activity and Health in School, Federal University of Ceara, Fortaleza, Brazil. blima@ufc.br.
authors.forename: Antônio Barroso
authors.initials: AB
authors.lastname: Lima
authors.affiliation: Institute of Physical Education and Sports, Research Centre in Physical Activity and Health in School, Federal University of Ceara, Fortaleza, Brazil. profeas@gmail.com.|Department of Clinical Medicine, Federal University of Ceara, Fortaleza, Brazil. profeas@gmail.com.
authors.forename: Evanice Avelino
authors.initials: EA
authors.lastname: de Souza
authors.affiliation: Institute of Physical Education and Sports, Research Centre in Physical Activity and Health in School, Federal University of Ceara, Fortaleza, Brazil. fabianegubert@hotmail.com.|Department of Nursing, Aids Project: Education and Prevention, Federal University of Ceara, Fortaleza, Brazil. fabianegubert@hotmail.com.
authors.forename: Fabiane do Amaral
authors.initials: Fdo A
authors.lastname: Gubert
authors.affiliation: Department of Physical Education, Research Centre in Physical Activity and Health, Federal University of Santa Catarina, Florianopolis, Brazil. ksilvajp@yahoo.com.br.
authors.forename: Kelly Samara
authors.initials: KS
authors.lastname: Silva
authors.affiliation: Institute of Physical Education and Sports, Research Centre in Physical Activity and Health in School, Federal University of Ceara, Fortaleza, Brazil. neivafrancenely@hotmail.com.|Department of Nursing, Aids Project: Education and Prevention, Federal University of Ceara, Fortaleza, Brazil. neivafrancenely@hotmail.com.
authors.forename: Neiva Francenely Cunha
authors.initials: NF
authors.lastname: Vieira
authors.affiliation: Institute of Physical Education and Sports, Research Centre in Physical Activity and Health in School, Federal University of Ceara, Fortaleza, Brazil. nicolino_trompieri@yahoo.com.br.|Department of Education-Fundamentals, Faculty of Education, Federal University of Ceara, Fortaleza, Brazil. nicolino_trompieri@yahoo.com.br.
authors.forename: Nicolino
authors.initials: N
authors.lastname: Trompieri Filho
authors.affiliation: Institute of Physical Education and Sports, Research Centre in Physical Activity and Health in School, Federal University of Ceara, Fortaleza, Brazil. thabyta.araujo@hotmail.com.|Department of Nursing, Aids Project: Education and Prevention, Federal University of Ceara, Fortaleza, Brazil. thabyta.araujo@hotmail.com.
authors.forename: Thábyta Silva
authors.initials: TS
authors.lastname: de Araújo
authors.affiliation: Department of Clinical Medicine, Federal University of Ceara, Fortaleza, Brazil. pedrobruin@gmail.com.
authors.forename: Pedro Felipe Carvalhedo
authors.initials: PF
authors.lastname: de Bruin
authors.affiliation: Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, Porto, Portugal. jmota@fade.up.pt.
authors.forename: Jorge
authors.initials: J
authors.lastname: Mota
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000523:psychology*; D001938:Brazil / Q000453:epidemiology; D015444:Exercise / Q000502:physiology; D005260:Female; D015438:Health Behavior; D006266:Health Education / Q000379:methods*; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008019:Life Style; D008297:Male; D063766:Pediatric Obesity / Q000453:epidemiology / Q000517:prevention & control*; D012107:Research Design; D013334:Students / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires