The Movement Program for an Active and Healthy Lifestyle in Adolescents

October 24, 2016 updated by: Kelly Samara da Silva

The Movement Program for an Active and Healthy Lifestyle in Adolescents and Its Relationship With School Performance

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1400

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Santa Catarina
      • Florianopolis, Santa Catarina, Brazil, 88.040-400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 10-months of intervention
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.
baseline and 4-months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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.
baseline and 10-months of intervention
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
baseline and 10-months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1.259.910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent Behavior

Clinical Trials on The Movement Program

3
Subscribe