NCT02439827

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,085

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

May 3, 2015

Last Update Submit

January 31, 2017

Conditions

Keywords

LifestyleInterventionMotor ActivityMediating VariablesMental HealthObesityAdolescent HealthSchoolHealth PromotionBrazil

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

EXPERIMENTAL

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.

Behavioral: "Fortaleça sua Saúde" program

Control

NO INTERVENTION

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.

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).

"Fortaleça sua Saúde" program

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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.

  • Barbosa 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.

  • Barbosa 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.

  • Barbosa 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.

MeSH Terms

Conditions

Adolescent BehaviorMotor ActivityPsychological Well-BeingObesity

Condition Hierarchy (Ancestors)

BehaviorPersonal SatisfactionOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adair S LOPES, PhD

    Federal University of Santa Catarina

    PRINCIPAL INVESTIGATOR

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