The "Fortaleça Sua Saúde" Program: A Cluster-randomized Controlled Trial to Promote Active and Healthy Lifestyle Among Brazilian Students
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,085
- Primary Endpoint
- Change from baseline in the daily time using TV/computer/video games at 4 months
Study Overview
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.
Detailed Description
Setting and Population:
Fortaleza is the capital of Ceara state, northeastern Brazil, and has a population of 2,452,185 inhabitants (the fifth largest city in Brazil considering the population). This municipality has an area of 314 km² and a Human Development Index (HDI) of 0.754. The city of Fortaleza is geographically divided into six administrative regions.
According to the Municipal Education Department, forty schools attended 6-9 grades and included the Programa Saúde na Escola, and six out of these schools had a full-time education model. These six schools attended approximately 2,500 students, of which 1,272 were enrolled in classes from 7th to 9th grades.
These six schools had similar characteristics (e.g., size, target audience, curriculum, etc.) and were located in different administrative regions (geographically disperses). Therefore, there was no need to conduct peer schools during random selection to prevent study contamination. Three schools were randomly selected to intervention group and other schools were control group. The neighborhood-HDI from where the six schools were located was similar between groups (neighborhood-HDI of 0.215, 0.341 and 0.443 for intervention schools, and 0.170, 0.377 and 0.491 for control schools).
Theoretical basis of the "Fortaleça sua Saúde" program:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
"Fortaleça sua Saúde" program
The intervention program was structured into four main components: (i) training and activities in general curriculum; (ii) training and activities in Physical Education classes; (iii) active opportunities in the school environment; (iv) health education in school community.
Intervention: "Fortaleça sua Saúde" program (Behavioral)
Control
Schools from the control group carried out one semester with the regular and conventional activities of a full-time school. In general, the control schools had two weekly Physical Education classes that include content and activities according to the perspective of their teachers. The conventional Programa Saúde na Escola were also performed in these schools.
Outcomes
Primary Outcomes
Change from baseline in the daily time using TV/computer/video games at 4 months
Time Frame: baseline and after 4-months of intervention
The daily time using TV/computer/video games of the patient will be estimated at baseline and after 4 months of intervention and the chance in this score for each patient will be calculated.
Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months
Time Frame: baseline and after 4-months of intervention
A list of 24 types of PA will be used to measuring the weekly frequency and the daily duration of each PA that the patients perform in a typical week. Thus, the weekly PA volume and the chance in this score for each patient will be calculated.
Secondary Outcomes
- Change from baseline in the stress score at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the body mass index at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the waist circumference at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the healthy eating score at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the quality of life score at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the self-rated health score at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the sleepiness score at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the academic performance score at 4 months(baseline and after 4-months of intervention)
- Change from baseline in the depression scale at 4 months among obese patients(baseline and after 4-months of intervention)
- Change from baseline in the eating disorders scale at 4 months among obese patients(baseline and after 4-months of intervention)
- Change from baseline in the objectively-measured physical activity time at 4 months among obese patients(baseline and after 4-months of intervention)
- Change from baseline in the body image score at 4 months(baseline and after 4-months of intervention)
Investigators
Valter Cordeiro Barbosa Filho
Master of Science in Physical Education, PhD Student in Physical Education
Universidade Federal de Santa Catarina