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Adolescent BehaviorEarly Phase 1NCT02944318

The Movement Program for an Active and Healthy Lifestyle in Adolescents

A Early Phase 1 study testing The Movement Program in people with Adolescent Behavior, run by Kelly Samara da Silva at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 12 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Adolescent Behavior
What is being tested?
The Movement Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,400 participants
Where
1 siteBrazil
Study dates
Mar 2014to Nov 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Kelly S Silva, Professor contact

ksilvajp@yahoo.com.br

Jaqueline A Silva, Master contact

jaqui_aragoni@hotmail.com

Brazil1 site, 1 recruiting

  • Kelly Samara da Silva

    Florianópolis, Santa Catarina, 88.040-400

    Jaqueline A Silva, Master, jaqui_aragoni@hotmail.com

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Being tested
The Movement Program
Keywords
Physical Activity, Healthy Lifestyle, Academic performance
Medical subject headings
Adolescent Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Movement ProgramBehavioural

    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).

Study groups in NCT02944318
Study groupRoleWhat they receive
"The Movement" ProgramExperimentalThe 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.
Receives: Behavioral: The Movement Program
No interventionNo interventionSchools 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 10-months of intervention

  2. 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.

    Measured: baseline and 4-months of intervention

Secondary outcomes (7)

  1. 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.

    Measured: baseline and 10-months of intervention

  2. 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.

    Measured: baseline and 10-months of intervention

  3. 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.

    Measured: baseline and 10-months of intervention

  4. 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.

    Measured: baseline and 10-months of intervention

  5. 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.

    Measured: baseline and 10-months of intervention

  6. 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.

    Measured: baseline and 10-months of intervention

  7. 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.

    Measured: baseline and 10-months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944318
Sponsor's protocol ID
1.259.910
Status last verified
Oct 2016
First submitted
24 Oct 2016
Last updated
25 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • da Costa RM, Lopes MVV, da Costa BGG, Malheiros LEA, Dos Santos PC, Arundell L, da Silva KS. Effect of a school-based multicomponent intervention on time-segmented physical activity and sedentary behavior among adolescents: a cluster randomized control trial. BMC Public Health. 2025 Nov 21;25(1):4090. doi: 10.1186/s12889-025-25314-3.

    PubMed 41272541

  • da Silva JA, da Silva KS, da Costa BGG, Lopes MVV, Salmon J. Movimente program: effectiveness and moderators of a cluster-randomized controlled trial on self-reported physical activity among Brazilian adolescents. BMC Public Health. 2025 Mar 15;25(1):1017. doi: 10.1186/s12889-025-22130-7.

    PubMed 40089742

  • 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.

    PubMed 34645402

  • 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.

    PubMed 33679529

  • 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.

    PubMed 32756101

  • 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.

    PubMed 32012323

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing The Movement Program in people with Adolescent Behavior, run by Kelly Samara da Silva at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kelly S Silva, Professor (ksilvajp@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in weekly time in moderate-to-vigorous physical activity at 10 months (time frame: baseline and 10-months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02944318, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.

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