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: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Individual and group HIV risk behavior counseling sessions | Arm Label: Attention-control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: health education and support group | Intervention Type: BEHAVIORAL; Name: Individual and group HIV risk behavior counseling sessions; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: health education and support group; Assigned to Arm(s): Attention-control group
B: Arm Label: COPE/Healthy Lifestyles TEEN Program; Type: EXPERIMENTAL; Interventions: Behavioral: COPE/Healthy Lifestyles TEEN Program. | Arm Label: Healthy Teens Attention Control Program; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Healthy Teens Attention Control Program | Intervention Type: BEHAVIORAL; Name: COPE/Healthy Lifestyles TEEN Program.; Assigned to Arm(s): COPE/Healthy Lifestyles TEEN Program | Intervention Type: BEHAVIORAL; Name: Healthy Teens Attention Control Program; Assigned to Arm(s): Healthy Teens Attention Control Program
C: Arm Label: Information only; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Information only | Arm Label: sexual risk reduction intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Sexual risk reduction intervention | Arm Label: SRRI+ETOH; Type: EXPERIMENTAL; Interventions: Behavioral: sexual risk reduction + alcohol risk reduction component | Intervention Type: BEHAVIORAL; Name: Information only; Assigned to Arm(s): Information only | Intervention Type: BEHAVIORAL; Name: Sexual risk reduction intervention; Assigned to Arm(s): sexual risk reduction intervention | Intervention Type: BEHAVIORAL; Name: sexual risk reduction + alcohol risk reduction component; Assigned to Arm(s): SRRI+ETOH
D: 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

Answer: D