Clinical trial NCT02944318: The Movement Program for an Active and Healthy Lifestyle in Adolescents
Official title: The Movement Program for an Active and Healthy Lifestyle in Adolescents and Its Relationship With School Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Adolescent Behavior
Keywords: Physical Activity
Healthy Lifestyle
Academic performance
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-10-25
Enrollment: 1400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: School is a favorable environment for the development of actions aimed at healthy behavioral changes. This project proposes to evaluate the effectiveness of an intervention program on aspects of lifestyle, with a focus on physical activity (PA) and reducing sedentary behaviors, and the relationship of these factors with the academic performance of students in the school from Florianopolis, SC, Brazil.

This is a randomized controlled intervention study enroling classes of 7th to 9th grade of fundamental education.

The intervention program will last for one year (about ten months), with three focuses: training of teachers, educational and environmental changes to behavior change.


Eligibility criteria: Inclusion Criteria:

Students of both sexes Students aged 12-15 years Students who are enrolled in 7-9 grade classes

Exclusion Criteria:

Students younger than 12 years-old and older than 15 years-old Students with uncompleted data at baseline and/or 10-months follow-up Students who dropout the school

Primary outcomes:
measure: Change from baseline in weekly time in moderate-to-vigorous physical activity at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the daily time using TV/computer/cellular/video games at 10 months
timeFrame: baseline and 4-months of intervention
Secondary outcomes:
measure: Change from baseline in the healthy eating score at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the body mass index at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the waist circumference at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the quality of life score at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the sleepiness score at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the academic performance score at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the body image score at 10 months
timeFrame: baseline and 10-months of intervention
Other outcomes:
measure: Change from baseline in the score of intrapersonal PA mediators at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the score of interpersonal PA mediators at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the score of environmental PA mediators at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the score of intrapersonal screen time use mediators at 10 months
timeFrame: baseline and 10-months of intervention
measure: Change from baseline in the score of interpersonal screen time use mediators at 10 months
timeFrame: baseline and 10-months of intervention
Locations:
city: Florianopolis
country: Brazil
facility: Kelly Samara da Silva
state: Santa Catarina
Study officials:
affiliation: Federal University of Santa Catarina
name: Kelly S Silva, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dos Santos PC, Salmon J, Arundell L, Lopes MVV, Silva KS. Effectiveness and moderators of a multicomponent school-based intervention on screen time devices: the Movimente cluster-randomized controlled trial. BMC Public Health. 2021 Oct 13;21(1):1852. doi: 10.1186/s12889-021-11895-2.
citation: Bandeira ADS, Beets MW, da Silveira PM, Lopes MVV, Barbosa Filho VC, da Costa BGG, Silva KS. Efforts on Changing Lifestyle Behaviors May Not Be Enough to Improve Health-Related Quality of Life Among Adolescents: A Cluster-Randomized Controlled Trial. Front Psychol. 2021 Feb 18;12:614628. doi: 10.3389/fpsyg.2021.614628. eCollection 2021.
citation: Silva KS, Silva JAD, Barbosa Filho VC, Santos PCD, Silveira PMD, Lopes MVV, Salmon J; "Movimente Program" Working Group. Protocol paper for the Movimente school-based program: A cluster-randomized controlled trial targeting physical activity and sedentary behavior among Brazilian adolescents. Medicine (Baltimore). 2020 Jul 31;99(31):e21233. doi: 10.1097/MD.0000000000021233.
citation: Knebel MTG, Borgatto AF, Lopes MVV, Dos Santos PC, Matias TS, Narciso FV, Silva KS. Mediating role of screen media use on adolescents' total sleep time: A cluster-randomized controlled trial for physical activity and sedentary behaviour. Child Care Health Dev. 2020 May;46(3):381-389. doi: 10.1111/cch.12755. Epub 2020 Feb 15.