Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Male or Female
* 3 to 5 years old
* Enrolled full-time at a participating, licensed daycare/child care facility

Exclusion Criteria:

* Activity restrictions due to disease: unstable cardiac or pulmonary disease, significant arthritis
* Other illness judged by the parent/guardian to make participation in this study inadvisable
* Significant cognitive deficit resulting in inability to understand or comply with instructions
* Inability to communicate in English or French
* Unwillingness of parent/guardian to sign informed consent
B: Inclusion Criteria:

* children at the age of 7 months and their families, recruited from the general population

Exclusion Criteria:

* severe sickness
C: Inclusion Criteria:

* All six full-time schools with the program called Programa Saúde na Escola in Fortaleza were eligible
* students of both sexes
* students aged 12-15 years
* students who are enrolled in 7-9 grade classes

Exclusion Criteria:

* students who are younger than 12 years-old and older than 15 years-old
* students with uncompleted data at baseline or 4-months follow-up
* students who are absence in the school days with data collection
* students who dropout the school
* students who refused to participate in data collection or intervention
D: Inclusion Criteria:

* Teens and parents of any gender, ethnicity/race, or socioeconomic status.
* Teens 14 to 16 years of age who are freshmen and sophomores taking a health class at one of the participating high schools.
* Teens who assent to participation.
* Teens with a custodial parent who consents for themselves and their teen's participation in the study.
* Teens who can speak and read in English (educational instruction in Arizona High Schools is conducted in English)

Exclusion Criteria:

* Teens who are under age 14 will be excluded because:

  * They are not likely to be enrolled in high school, and
  * They are unlikely to have sufficient cognitive development to benefit from the proposed intervention
* Teens who are over age 16 will be excluded for two key reasons:

  * We believe that the cognitive development of and social expectations for older teens requires a more complex and flexible intervention than that proposed, and
  * Teens need to be available for 12 month follow-up sessions (our pilot studies indicated that this becomes less likely once teens are old enough to leave/graduate from high school, emancipate from parents, and/or leave home).

Answer: C