The Movement Program for an Active and Healthy Lifestyle in Adolescents

Adolescent Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944318
• Other study ID #: 1.259.910
• Status: Recruiting
• Phase: Phase 0
• First received: October 24, 2016
• Last updated: October 24, 2016
• Start date: March 2014
• Est. completion date: November 2018

Study information

• Verified date: October 2016
• Source: Universidade Federal de Santa Catarina
• Contact: Kelly S Silva, Professor
• Email: ksilvajp[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: November 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

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).

Locations

Country	Name	City	State
Brazil	Kelly Samara da Silva	Florianopolis	Santa Catarina

Sponsors (2)

Lead Sponsor	Collaborator
Kelly Samara da Silva	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in the score of intrapersonal PA mediators at 10 months	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	Yes
Other	Change from baseline in the score of interpersonal PA mediators at 10 months	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	Yes
Other	Change from baseline in the score of environmental PA mediators at 10 months	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	Yes
Other	Change from baseline in the score of intrapersonal screen time use mediators at 10 months	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	Yes
Other	Change from baseline in the score of interpersonal screen time use mediators at 10 months	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	Yes
Primary	Change from baseline in weekly time in moderate-to-vigorous physical activity at 10 months	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	Yes
Primary	Change from baseline in the daily time using TV/computer/cellular/video games at 10 months	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	Yes
Secondary	Change from baseline in the healthy eating score at 10 months	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	Yes
Secondary	Change from baseline in the body mass index at 10 months	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	Yes
Secondary	Change from baseline in the waist circumference at 10 months	Difference in the waist circumference (cm) between baseline and after 10 months of intervention will be calculated.	baseline and 10-months of intervention	Yes
Secondary	Change from baseline in the quality of life score at 10 months	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	Yes
Secondary	Change from baseline in the sleepiness score at 10 months	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	Yes
Secondary	Change from baseline in the academic performance score at 10 months	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	Yes
Secondary	Change from baseline in the body image score at 10 months	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	Yes