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:

* Schools with at least one full course of 3rd of early childhood education and one of 1st primary school.
* The Boards of Governors (community participatory organ in each school) give its approval to the intervention and measurements at the beginning and end of the course.
* Children 4 to 7 years old.
* Children's parents/caregivers will give their written consent to the children's participation.
* Collaboration in the family to respond to questionnaires on family leisure habits, sleeping, eating, getting around town, etc., included in the measurement protocol of this project.

Exclusion Criteria:

* Have a malformation that prevents learning of the Spanish language (or Spanish sign language).
* Have some kind of physical or mental disorder identified by parents or teachers that prevent physical activity.
* Have a chronic illness such as heart disease, diabetes or asthma, as determined by their pediatrician/family doctor -after analysis of the activities program- prevents participation in them.
B: 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
C: Inclusion Criteria:

* all children attending 5th grade at the invited schools in Sogn og Fjordane county (Norway) during the school-year 2014/2015

Exclusion Criteria:

* those children whom for language barriers are unable to perform national tests in Numeracy, Norwegian and English
D: Inclusion Criteria:

* 7-11 years of age
* BMI greater than or equal to the 85th percentile for age and sex on the 2000 U.S. Centers for Disease Control and Prevention (CDC) BMI reference

Exclusion Criteria:

* Have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated with obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy);
* Take medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
* Have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason);
* Have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in her native language);
* Are unable to read, understand or complete informed consent in English or Spanish;
* Plan to move from the San Francisco Bay Area within the next 36 months.
* Are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the Principal Investigator.

Answer: B