Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The "Fortaleça Sua Saúde" Program: A Cluster-randomized Controlled Trial to Promote Active and Healthy Lifestyle Among Brazilian Students
Brief Summary: Background:

Interventions on lifestyle among adolescents are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle have been little explored. Investigators present the rationale and methods of a cluster-randomized controlled trial aimed to promote promotion active and healthy lifestyle (especially physical activity \[PA\] practice and reducing screen time use) among Brazilian students - the "Fortaleça sua Saúde" ("Strengthen Your Health" in Portuguese) program.

Methods/Design:

This is a school-based cluster-randomized controlled trial that included students from six elementary full-time public schools (7-9 grades) in Fortaleza, northeastern Brazil. The intervention duration was one academic semester (approximately four months) in 2014. The intervention strategies focused on teachers' training and activities on health in curriculum (including a specific training to Physical Education teachers), active opportunities in the school environment (availability of spaces and materials for PA) and health education (production and exhibition of health material at school, and distributing pamphlets to patients). Data collection will be performed before and immediately after 4 months of intervention. The primary variables include the practice of PA (weekly PA volume) and the screen time use (TV/computer/video games). Intrapersonal, interpersonal and environmental variables associated to PA and screen time use will be evaluated by standardized questionnaire. Other components of the lifestyle (e.g., eating habits), psychological (e.g., self-rated health, body satisfaction), biological (general and abdominal obesity) and academic performance will be also evaluated in the patients. Depressive symptoms, eating disorders, sleep quality, objectively-measured physical activity will be evaluated in obese patients.

Discussion:

Is effective, this program will contribute to the development of public policies for active and health lifestyle promotion among young population, especially from low- and middle-income countries. The main variables (intrapersonal, interpersonal and/or environmental stimulus) that help the young people to adopt an active lifestyle also may be indicated. Finally, investigators expect that the proposed strategies may be adaptable to the public school reality and they may be extended to the entire school system.


Options:
A: Arm Label: "Fortaleça sua Saúde" program; Type: EXPERIMENTAL; Interventions: Behavioral: "Fortaleça sua Saúde" program | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: "Fortaleça sua Saúde" program; Assigned to Arm(s): "Fortaleça sua Saúde" program
B: Arm Label: Breakfast Skipping; Type: EXPERIMENTAL; Interventions: Behavioral: Breakfast Skipping | Arm Label: Normal Protein Breakfast Meals; Type: EXPERIMENTAL; Interventions: Behavioral: Normal Protein Breakfast Meals | Arm Label: Protein-rich Breakfast Meals; Type: EXPERIMENTAL; Interventions: Behavioral: Protein-rich Breakfast Meals | Intervention Type: BEHAVIORAL; Name: Breakfast Skipping; Assigned to Arm(s): Breakfast Skipping | Intervention Type: BEHAVIORAL; Name: Normal Protein Breakfast Meals; Assigned to Arm(s): Normal Protein Breakfast Meals | Intervention Type: BEHAVIORAL; Name: Protein-rich Breakfast Meals; Assigned to Arm(s): Protein-rich Breakfast Meals
C: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Low Dose; Type: EXPERIMENTAL; Interventions: Behavioral: Aerobic exercise program | Arm Label: High dose; Type: EXPERIMENTAL; Interventions: Behavioral: Aerobic exercise program | Intervention Type: BEHAVIORAL; Name: Aerobic exercise program; Assigned to Arm(s): High dose, Low Dose
D: Arm Label: Lifestyle modification; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Healthy Kids-Houston program | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Control | Intervention Type: BEHAVIORAL; Name: Healthy Kids-Houston program; Assigned to Arm(s): Lifestyle modification | Intervention Type: BEHAVIORAL; Name: Control; Assigned to Arm(s): Control

Answer: A