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 (for caregivers/parents):

1. Age 18 or older;
2. Primary caregiver responsible for the care of a child between the ages of two and nine;
3. Report elevated levels of child behavior problems for the child that he/she chooses to be part of the study (based on the Child and Adolescent Disruptive Behavior Inventory, oppositional defiant disorder subscale (8 items); scores of 10 or more
4. Have lived in the same household as this child at least four nights a week in the previous month and will continue to do so;
5. Agreement of being randomized to one of the two conditions
6. Provision of Informed consent to participate in the full study
7. Language skills to participate in the group/lecture (e.g., with someone that helps with the translation).

Exclusion Criteria (for caregivers/parents):

1. Parents with legal restriction to child care - indirectly assessed via the inclusion criterion on the number of nights/day with the child/per week

Inclusion Criteria (for facilitators of PLH/lecture):

1. Age 18 or older;
2. Participate in PLH facilitator training workshop /lecture training workshop;
3. Agreement to either deliver the lecture (one session) or PLH-YC (five sessions);
4. Provision of consent to participate in the full study.
B: Inclusion criteria for villages (n = 8):

1. Situated within 1 hour driving distance from Shinyanga, Tanzania
2. Provide community consent via community local leader and approval from local authorities
3. Contain registered farmer groups

Inclusion criteria for participating farmer groups (n = 16, 2 per village):

1. Situated within participating village
2. Registered with Tanzanian Ministry of Agriculture within the previous 3 years
3. Registered to participate in ICS's Agribusiness and Skilful Parenting programme
4. Provide consent via farmer group leader

Inclusion criteria for adults caregivers (n = 240, 30 per village):

1. Age 18 or older
2. Serves as the primary caregiver of a child in the household between the ages of 3 and 17
3. Lives in the house at least 4 nights per week.
4. Is a registered member of the included agricultural farmer group
5. Provides consent to participate in the full study

Exclusion criteria for adult participants:

1. Any adult exhibiting severe mental health problems or acute mental disabilities.
2. Any adult that has been referred to social services or child protection services during the course of baseline data collection as a result of reported or observed indications of significant potential psychological harm towards a child.

Inclusion criteria for child respondents (n = 240, 30 per village):

1. Age 10 to 17 years at initial assessment
2. Lives in the house at least 4 nights per week
3. Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study
4. Provides assent to participate in the full study

Exclusion criteria for child respondents:

1. Any child who is either experiencing severe mental health problems, has acute developmental disabilities,
2. If the child participant has been referred to social services during baseline data collection due to reported or observed indications of significant harm.

Inclusion criteria for observed children (n = 240, 30 per village):

1. Age 0 to 3 years at initial assessment
2. Lives in the house at least 4 nights per week
3. Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study

Inclusion criteria for adult ICS programme facilitators:

1. Age 18 or older
2. Is registered as a facilitator of ICS's Agribusiness or Skilful Parenting programme
3. Provides consent to participate in the full study
C: Inclusion Criteria:

* Youth between the ages of 12 and 24 years of age, attending the Teen Club HIV clinic at Kilimanjaro Christian Medical Centre (KCMC) and/or Mawenzi Hospital and receiving ART
* if \> or =l to 18 years, able to understand the project and provide written, informed consent
* if \< 18 years, a parent or guardian must provide written permission and participant must be able to assent
* all adolescents must also commit to attending 10 weekly CBT (SYV) sessions and 2 individual sessions.

Exclusion Criteria:

* Active psychosis, developmental delay, or cognitive disability that precludes active participation in consent process, intervention, and assessment interviews.
D: 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

Answer: D