NCT03153176

Brief Summary

Background: The health promotion actions carried out in the school environment have positive effects on reducing risk factors for chronic diseases in adolescents. Interdisciplinary strategies involving school and family to increase the level of physical activity among adolescents, inside and outside the school, are essential to encourage healthier lifestyles. Aim: To determine whether a 24-weeks interdisciplinary intervention program promotes improvement in the level of physical activity, physical fitness, sleep quality, life satisfaction, eating habits and reduce the sedentary behavior of schoolchildren aged 10 to 13 years of public schools in the city of Presidente Prudente, São Paulo, Brazil. The intervention: Includes training of teacher Physical Education in the principles of self-determination theory and ecological theory at practical applications for motivating adolescents in physical activities and sports. The students will be given information on the benefits of a physically active lifestyle and will be encouraged to participated the new opportunities for physical activity in their school and community. The program will offer physical activity strategies over the 24-weeks during class Physical Education, afternoon recess and active lesson breaks in theoretical classes. Nutritional guidelines and gardening experience will be developed to encourage healthy eating habits among schoolchildren and to reduce salt, oil and sugar in the preparation of school lunch. Methods/design: The project, which being conducted as cluster randomized trial, is to evaluated whit in a mixed methods, including qualitative and quantitative approach will be used for the construction of the actions integrated to the school physical education curriculum and evaluation of the program by the participants and supporters. The RE-AIM evaluation metric (Reach, Effectiveness, Adoption, Implementation, and Maintenance) is used to guide the validation this program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2018

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

May 7, 2017

Last Update Submit

June 3, 2019

Conditions

Keywords

physical activityphysical fitnesseating habitssedentary behaviorsleep qualitysatisfaction personalschool healthadolescent

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in weekly time in moderate-to-vigorous physical activity at six months

    Measured with accelerometers for tenn days and supplemented with a questionnaire

    Baseline, end of intervention (6 months), 1 year after baseline

  • Change from baseline in weekly time in sedentary activity at six months

    Measured with accelerometers for tenn days and supplemented with a questionnaire

    Baseline, end of intervention (6 months), 1 year after baseline

Secondary Outcomes (4)

  • Change from baseline in Physical Education class time in moderate-to-vigorous physical activity at six months

    Baseline, end of intervention (6 months), 1 year after baseline

  • Change from baseline in level physical fitness at six months

    Baseline, end of intervention (6 months), 1 year after baseline

  • Change from baseline in body composition at six months

    Baseline, end of intervention (6 months), 1 year after baseline

  • Change from baseline in caloric intake at six months

    Baseline, end of intervention (6 months), 1 year after baseline

Other Outcomes (3)

  • Change from baseline in the time and quality sleep at six months

    Baseline, end of intervention (6 months), 1 year after baseline

  • Change from baseline in performance academic at six months

    Baseline, end of intervention (6 months), 1 year after baseline

  • Change from baseline in satisfaction with life at six months

    Baseline, end of intervention (6 months), 1 year after baseline

Study Arms (2)

intervention

EXPERIMENTAL

Training program for Physical Education teacher. Individual level: moderate to vigorous physical activity. Organizational level: school health policy for healthy lifestyle

Behavioral: TrainingBehavioral: Individual levelBehavioral: Organizational level

no intervention

NO INTERVENTION

Physical Education and school curriculum as usual

Interventions

TrainingBEHAVIORAL

Training program 30 hours accumulated before, during and after intervention

Also known as: Training program for Physical Education teacher
intervention

7 to 10 minutes in Physical Education in class time, 3 sections for week during lunch break

Also known as: Moderate to vigorous physical activity
intervention

Inclusion of actions in the school curriculum: counseling sections with health for parents and adolescent, active lesson breaks during theoretical class, gardening experience in school, nutrition guidance for school lunch professionals.

Also known as: School health policy for healthy lifestyle
intervention

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students enrolled in 2017, in the 6th and 7th year of Elementary School in the full-time schools participating in the study

You may not qualify if:

  • Students with physical or motor impairment that prevents the performance of physical fitness assessments or with mental or cognitive impairment that prevents them from responding with clarity to the questionnaires and instruments of data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sueyla Ferreira da Silva dos Santos

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

Related Publications (1)

  • Ferreira da Silva Dos Santos S, Bordin D, Dornelas de Souza EF, Freitas Junior IF. Study protocol and baseline characteristics of "SCHOOL IN ACTION" program on support to physical activity and healthy lifestyles in adolescents. Contemp Clin Trials Commun. 2019 Dec 14;17:100505. doi: 10.1016/j.conctc.2019.100505. eCollection 2020 Mar.

MeSH Terms

Conditions

Motor ActivityFeeding BehaviorSedentary BehaviorAdolescent BehaviorSleep Initiation and Maintenance DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

BehaviorBehavior, AnimalSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Ismael Freitas Junior, Phd

    CELAPAM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation, and those who evaluate the outcomes of the main outcome (physical activity, sedentary behavior, dietary intake and body composition) will be blind to baseline group assignment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: physical activity and lifestyle intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 15, 2017

Study Start

May 8, 2017

Primary Completion

June 9, 2017

Study Completion

December 7, 2018

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

This sharing is available for principal researchers and collaborators and may be obtained by individual report after data analysis

Locations