The Movement Program for an Active and Healthy Lifestyle in Adolescents

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Adolescent Behavior	Behavioral: The Movement Program	Early Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1400 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Movement Program for an Active and Healthy Lifestyle in Adolescents and Its Relationship With School Performance
Study Start Date :	March 2014
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	November 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: "The Movement" Program; The intervention program was structured according three main components: (1) training and activities in general curriculum and Physical Education classes; (2) active facilities in the school environment; (3) health education in school community.	Behavioral: The Movement Program; The program duration will be one academic year (around ten months) in 2017. The intervention strategies will focus on: (1) teachers' training and activities on health in curriculum; (2) active opportunities in the school environment (facilities and materials for PA practice) and (3) health education (posters and folders to students and parents).
No Intervention: No intervention; Schools in the control group will maintain a regular academic year with conventional activities. Thus schools have two weekly Physical Education classes which are organized by according to the perspective of their teachers. Besides that, the Program "Saúde na Escola" is also performed.

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in weekly time in moderate-to-vigorous physical activity at 10 months [ Time Frame: baseline and 10-months of intervention ]
   A list containing 24 types of PA will be used to measure the weekly frequency and the daily duration of each type of PA that the adolescents perform in a typical week.
2. Change from baseline in the daily time using TV/computer/cellular/video games at 10 months [ Time Frame: baseline and 4-months of intervention ]
   The daily time spent using TV/computer/video games of the individual will be estimated at baseline and after 10 months of intervention.

Secondary Outcome Measures :

1. Change from baseline in the healthy eating score at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Healthy eating score will be estimated using two items related to healthy foods (fruits and vegetables) and three unhealthy (soft drinks, savory and sweets) foods in a typical week. Points from this list will be estimated at baseline and after 10 months of intervention.
2. Change from baseline in the body mass index at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Body weight (kg) and height (m) will be used to calculate the body mass index (weight/height², kg/m²). Difference between baseline and after 10 months of intervention will be calculated.
3. Change from baseline in the waist circumference at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Difference in the waist circumference (cm) between baseline and after 10 months of intervention will be calculated.
4. Change from baseline in the quality of life score at 10 months [ Time Frame: baseline and 10-months of intervention ]
   The quality of life will be measured using the KidScreen instrument. Difference in this score between baseline and after 10 months of intervention will be calculated.
5. Change from baseline in the sleepiness score at 10 months [ Time Frame: baseline and 10-months of intervention ]
   The difference of frequency and quality of sleep between baseline and after 10 months of intervention will be calculated.
6. Change from baseline in the academic performance score at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Academic achievement and school attendance will be evaluated in order to create an academic performance score. Difference in this score between baseline and after 10 months of intervention will be calculated.
7. Change from baseline in the body image score at 10 months [ Time Frame: baseline and 10-months of intervention ]
   The self-assessment of the nine-silhouettes scale proposed by Stunkard et al. will be used to create the body image score. Difference in this score between baseline and after 10 months of intervention will be calculated.

Other Outcome Measures:

1. Change from baseline in the score of intrapersonal PA mediators at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Points obtained from a list of attitude (5 items), expectations (10 items) and self-efficacy (12 items) variables will be estimated at baseline and after 4 months of intervention.
2. Change from baseline in the score of interpersonal PA mediators at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Points obtained from a list of parental support (7 items), friends support (6 items), physical education teachers (6 items) and general teachers support (6 items) scale will be estimated at baseline and after 4 months of intervention.
3. Change from baseline in the score of environmental PA mediators at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Points obtained from a list of school environment (4 items) scale will be estimated at baseline and after 10 months of intervention.
4. Change from baseline in the score of intrapersonal screen time use mediators at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Points obtained from a list of attitude (3 items), expectations (12 items) and self-efficacy (11 items) variables will be estimated at baseline and after 10 months of intervention.
5. Change from baseline in the score of interpersonal screen time use mediators at 10 months [ Time Frame: baseline and 10-months of intervention ]
   Points obtained from a list of family and friends modelling (4 items), social support (4 items), family beliefs (3 items) and family norms (6 items) variables will be estimated at baseline and after 10 months of intervention

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Kelly S Silva, Professor		ksilvajp@yahoo.com.br
Contact: Jaqueline A Silva, Master		jaqui_aragoni@hotmail.com

Locations

Brazil
Kelly Samara da Silva	Recruiting
Florianopolis, Santa Catarina, Brazil, 88.040-400
Contact: Jaqueline A Silva, Master jaqui_aragoni@hotmail.com

Sponsors and Collaborators

Kelly Samara da Silva

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Principal Investigator:	Kelly S Silva, Professor	Federal University of Santa Catarina

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kelly Samara da Silva, Principal Investigator, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier:	NCT02944318 History of Changes
Other Study ID Numbers:	1.259.910
First Posted:	October 25, 2016
Last Update Posted:	October 25, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Kelly Samara da Silva, Universidade Federal de Santa Catarina:

Physical Activity; Healthy Lifestyle; Academic performance