The "Fortaleça Sua Saúde" Program for Active and Healthy Lifestyle Among Brazilian Students
1 other identifier
interventional
1,085
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 3, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 2, 2017
January 1, 2017
5 months
May 3, 2015
January 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months
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.
baseline and after 4-months of intervention
Change from baseline in the daily time using TV/computer/video games at 4 months
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.
baseline and after 4-months of intervention
Secondary Outcomes (12)
Change from baseline in the healthy eating 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 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
- +7 more secondary outcomes
Other Outcomes (6)
Change from baseline in the score of intrapersonal PA mediators at 4 months
baseline and after 4-months of intervention
Change from baseline in the score of interpersonal PA mediators at 4 months
baseline and after 4-months of intervention
Change from baseline in the score of environmental PA mediators at 4 months
baseline and after 4-months of intervention
- +3 more other outcomes
Study Arms (2)
"Fortaleça sua Saúde" program
EXPERIMENTALThe 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.
Control
NO INTERVENTIONSchools 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.
Interventions
The program duration was of one academic semester (approximately four months) in 2014. The intervention strategies focus 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 students and parents).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Bandeira ADS, Silva KS, Bastos JLD, Silva DAS, Lopes ADS, Barbosa Filho VC. Psychosocial mediators of screen time reduction after an intervention for students from schools in vulnerable areas: A cluster-randomized controlled trial. J Sci Med Sport. 2020 Mar;23(3):264-269. doi: 10.1016/j.jsams.2019.09.004. Epub 2019 Sep 13.
PMID: 31543460DERIVEDBarbosa Filho VC, Bandeira ADS, Minatto G, Linard JG, Silva JAD, Costa RMD, Manta SW, Sa SAM, Matias TS, Silva KSD. Effect of a Multicomponent Intervention on Lifestyle Factors among Brazilian Adolescents from Low Human Development Index Areas: A Cluster-Randomized Controlled Trial. Int J Environ Res Public Health. 2019 Jan 18;16(2):267. doi: 10.3390/ijerph16020267.
PMID: 30669291DERIVEDBarbosa Filho VC, da Silva KS, Mota J, Vieira NFC, Gubert FDA, Lopes ADS. "For whom was it effective?" Moderators of the effect of a school-based intervention on potential physical activity determinants among Brazilian students. Prev Med. 2017 Apr;97:80-85. doi: 10.1016/j.ypmed.2017.01.007. Epub 2017 Jan 19.
PMID: 28111095DERIVEDBarbosa Filho VC, Lopes Ada S, Lima AB, de Souza EA, Gubert Fdo A, Silva KS, Vieira NF, Trompieri Filho N, de Araujo TS, de Bruin PF, Mota J; "Fortaleca sua Saude" Working Group. Rationale and methods of a cluster-randomized controlled trial to promote active and healthy lifestyles among Brazilian students: the "Fortaleca sua Saude" program. BMC Public Health. 2015 Dec 7;15:1212. doi: 10.1186/s12889-015-2543-2.
PMID: 26643919DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adair S LOPES, PhD
Federal University of Santa Catarina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Science in Physical Education, PhD Student in Physical Education
Study Record Dates
First Submitted
May 3, 2015
First Posted
May 12, 2015
Study Start
July 1, 2014
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
February 2, 2017
Record last verified: 2017-01