Physical ActivityEANCT03153176
"Escola em Ação" (School in Action)
A study testing Training, Individual level and Organizational level in people with Physical Activity and Eating Behavior, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Eating Behavior, Sedentary Lifestyle
- What is being tested?
- Training, Individual level and Organizational level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteBrazil
- Study dates
- 8 May 2017to 7 Dec 2018
- Phase
- Interventional
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in 2017, in the 6th and 7th year of Elementary School in the full-time schools participating in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sueyla Ferreira da Silva dos Santos
Presidente Prudente, São Paulo, 19060-900
About this study
Official title: "Escola em Ação": School Based Interventions of Incentive to the Practice Physical and Life Habits of Healthy Promotion
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.
Read more
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.
Read the detailed description
The intervention will be unfold over the 24-weeks with students of six to seven school terms of implementation physical activity and nutrition intervention strategies. The total of five schools full-time were contacted for participation in the survey, one was excluded because they had no interest in participating. Allocation of pairs of schools in the experimental and control groups was done by randomization (draw for the experimental and control groups), and later the schools were informed about their condition in the study (experimental group or control group). The dimensions assessed in the research were defined from the problems and needs pointed out by the school in the initial stage of training and diagnosis of the local reality. The intervention strategies consisted of the following across: promote teacher Physical Education training; develop school actions integrated in the school curriculum; increase pratice of physical activity (in class time and recess); Improve eating habits (nutritional guidence, gardening experience, school lunch); promote healthy lifestyle program during school breaks; provided with physical activity equipment; parent engagement in health education practice.
- Being tested
- Training, Individual level, Organizational level
- Keywords
- physical activity, physical fitness, eating habits, sedentary behavior, sleep quality, satisfaction personal, school health, adolescent
- Medical subject headings
- Motor Activity, Feeding Behavior, Sedentary Behavior, Adolescent Behavior, Sleep Initiation and Maintenance Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Also called Training program for Physical Education teacher
Training program 30 hours accumulated before, during and after intervention
Individual levelBehavioural
Also called Moderate to vigorous physical activity
7 to 10 minutes in Physical Education in class time, 3 sections for week during lunch break
Organizational levelBehavioural
Also called School health policy for healthy lifestyle
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Training program for Physical Education teacher. Individual level: moderate to vigorous physical activity. Organizational level: school health policy for healthy lifestyle Receives: Behavioral: Training; Behavioral: Individual level; Behavioral: Organizational level |
| no intervention | No intervention | Physical Education and school curriculum as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured with accelerometers in Physical Education class
Measured: Baseline, end of intervention (6 months), 1 year after baseline
Change from baseline in level physical fitness at six months
Measured with physical fitness test (abdominal resistance, palmar grip, horizontal jump, Wells bench, beep test)
Measured: Baseline, end of intervention (6 months), 1 year after baseline
Change from baseline in body composition at six months
Measured with Dual-energy X-ray absorptiometry (DXA) and anthropometric measurements (body height, body weight, waist circumference, hip circumference, arm circumference, triceps skin fold and puberty status (self- assessed)
Measured: Baseline, end of intervention (6 months), 1 year after baseline
Change from baseline in caloric intake at six months
Measured with food register at 3 days and supplemented with a questionnaire
Measured: Baseline, end of intervention (6 months), 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start8 May 2017
- Primary completion9 Jun 2017
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- physical activity and lifestyle intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Sueyla Ferreira da Silva dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Ismael Freitas Junior, Phd, Study director, CELAPAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153176
- Sponsor's protocol ID
- UNESP Presidente Prudente
- Acronym
- EA
- Status last verified
- Jun 2019
- First submitted
- 7 May 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This sharing is available for principal researchers and collaborators and may be obtained by individual report after data analysis
Publications
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.
PubMed 32211554
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Escola em Ação": School Based Interventions of Incentive to the Practice Physical and Life Habits of Healthy Promotion
- ClinicalTrials.gov ID
- NCT03153176
- Acronym / sponsor ID
- EA / UNESP Presidente Prudente
- Keywords
- physical activity, physical fitness, eating habits, sedentary behavior, sleep quality, satisfaction personal, school health, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 8 May 2017 (actual)
- Primary completion
- 9 Jun 2017 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The intervention will be unfold over the 24-weeks with students of six to seven school terms of implementation physical activity and nutrition intervention strategies. The total of five schools full-time were contacted for participation in the survey, one was excluded because they had no interest in participating. Allocation of pairs of schools in the experimental and control groups was done by randomization (draw for the experimental and control groups), and later the schools were informed about their condition in the study (experimental group or control group). The dimensions assessed in the research were defined from the problems and needs pointed out by the school in the initial stage of training and diagnosis of the local reality. The intervention strategies consisted of the following across: promote teacher Physical Education training; develop school actions integrated in the school curriculum; increase pratice of physical activity (in class time and recess); Improve eating habits (nutritional guidence, gardening experience, school lunch); promote healthy lifestyle program during school breaks; provided with physical activity equipment; parent engagement in health education practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- physical activity and lifestyle intervention
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Training, Behavioral: Individual level, Behavioral: Organizational levelTraining program for Physical Education teacher. Individual level: moderate to vigorous physical activity. Organizational level: school health policy for healthy lifestyle |
| no intervention | No intervention | –Physical Education and school curriculum as usual |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students enrolled in 2017, in the 6th and 7th year of Elementary School in the full-time schools participating in the study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingAlso: Training program for Physical Education teacherTraining program 30 hours accumulated before, during and after intervention | Behavioural | intervention |
| Individual levelAlso: Moderate to vigorous physical activity7 to 10 minutes in Physical Education in class time, 3 sections for week during lunch break | Behavioural | intervention |
| Organizational levelAlso: School health policy for healthy lifestyleInclusion 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. | Behavioural | intervention |
Primary outcome
Change from baseline in weekly time in moderate-to-vigorous physical activity at six months
Time frame: Baseline, end of intervention (6 months), 1 year after baseline
Measured with accelerometers for tenn days and supplemented with a questionnaire
Change from baseline in weekly time in sedentary activity at six months
Time frame: Baseline, end of intervention (6 months), 1 year after baseline
Measured with accelerometers for tenn days and supplemented with a questionnaire
4 secondary outcomes
Change from baseline in Physical Education class time in moderate-to-vigorous physical activity at six months
Time frame: Baseline, end of intervention (6 months), 1 year after baseline
Change from baseline in level physical fitness at six months
Time frame: Baseline, end of intervention (6 months), 1 year after baseline
Change from baseline in body composition at six months
Time frame: Baseline, end of intervention (6 months), 1 year after baseline
Change from baseline in caloric intake at six months
Time frame: Baseline, end of intervention (6 months), 1 year after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 32211554Ferreira 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.
- Individual participant dataSharing planned: No. This sharing is available for principal researchers and collaborators and may be obtained by individual report after data analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismael Freitas Junior, Phd study director
CELAPAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training, Individual level and Organizational level in people with Physical Activity and Eating Behavior, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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: finished, as of the sponsor's last update on 5 Jun 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 six months (time frame: Baseline, end of intervention (6 months), 1 year after baseline). 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 NCT03153176, which also lists 1 linked publication.
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 5 Jun 2019.