Physical ActivityNCT02024763
Educational Program and Schoolchildren's Energy Expenditure
A study testing Educational Intervention in people with Physical Activity, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The aim of this study was to evaluate the impact of a classroom teachers' educational intervention on 1st and 2nd grades children's physical activity level and energy expenditure during physical education classes in elementary public schools, in São Paulo, Brazil. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 1999to Nov 2000
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children from 7 to 10 years of age, enrolled at 1st or 2nd grades of selected schools in Vila Mariana - Sao Paulo.
Who cannot join
- Not have both observations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Educational Program on Schoolchildren's Energy Expenditure During Physical Education Classes
The aim of this study was to evaluate the impact of a classroom teachers' educational intervention on 1st and 2nd grades children's physical activity level and energy expenditure during physical education classes in elementary public schools, in São Paulo, Brazil.
Read the detailed description
This study is a School-based Randomized Controlled Trial. Three-step cluster sampling was used for subject selection. In the first step, 8 schools in the Vila Mariana district - São Paulo were selected and assigned randomly to physical activity intervention (3 schools) or control condition (5 schools). In the second step, all 48 classes from the 1st and 2nd grades were selected. In the third step, 352 children were randomly selected compose the observational group. In both groups, questionnaire data and SOFIT's observation were collected two times: "pre" (immediately before the intervention), and "post" (immediately after the intervention), with a six weeks interval between them. No educational intervention was taken place in the control schools while the project was running. Afterwards control schools received training.
- Conditions
- Physical Activity
- Being tested
- Educational Intervention
- Keywords
- Energy Expenditure, Physical Education, Children, Randomized Controlled Trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
Intervention was applied to classroom teachers by the multidisciplinary team of the RRIDA Project. Training lasted six weeks, 12 hours devoted to physical activity and 18 hours to nutritional content. Modules of educational activities to classroom teachers were to be replicated at PE classes to children from 1st and 2nd grades of three exposed schools. The physical activity module was based on a theoretical approach of physical activity benefits and risks for health, children's physical fitness and activity patterns, physical education and change behavior models.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | Intervention was applied to classroom teachers by the RRIDA Project team. Training lasted six weeks, 12 hours devoted to physical activity and 18 hours to nutritional content. Modules of educational activities were taught in order to be replicated at PE classes to 1st and 2nd grades' children of three exposed schools. Physical activity module was based on a theoretical approach of physical activity benefits and risks for health, children's physical fitness and activity patterns, physical education and change behavior models. In each meeting the PE professionals, performed PE classes with the classroom teachers as students, focusing in strategies to keep them in movement for the most of PE class time to stimulate students' joint participation instead of individual participation or games. Receives: Behavioral: Educational Intervention |
| No Intervention | No intervention | No educational intervention was taken place in the control schools while the project was running. Afterwards, control schools received training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in children's Physical Activity Level / Energy Expenditure after an Educational Intervention for classroom teachers.
From eight elementary Public Schools we randomly selected three to receive an educational intervention for teachers. In order to evaluate intervention results, all the 1st and 2nd grades, from exposed and unexposed schools were nominated to have selected children. In each class, eight children were randomly selected. To assess children's level of physical activity, Physical Education classes were recorded. The videotapes analysis set the level of student's physical activity, teacher's attitude, and the class context. The observation instrument used was SOFIT - System for Observing Fitness Instruction Time. We analyzed and discussed the change in children's Physical Activity Level and Energy Expenditure before and after the Educational Intervention to classroom teachers, with a six weeks interval.
Measured: Children's Physical Activity Level / Energy Expenditure were measured before and after an Educational Intervention to classroom teachers, with a six weeks interval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startSep 1999
- Primary completionNov 2000
- Study completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Poblacion, Federal University of São Paulo
- Investigators
- Jose Augusto AC Taddei, MD, Dr PH, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024763
- Sponsor's protocol ID
- APkit
- Status last verified
- Dec 2013
- First submitted
- 27 Dec 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Program on Schoolchildren's Energy Expenditure During Physical Education Classes
- ClinicalTrials.gov ID
- NCT02024763
- Acronym / sponsor ID
- APkit
- Conditions
- Physical Activity
- Keywords
- Energy Expenditure, Physical Education, Children, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Nov 2000 (actual)
- Study completion
- Nov 2000 (actual)
- First posted
- 31 Dec 2013 (estimated)
- 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.
The aim of this study was to evaluate the impact of a classroom teachers' educational intervention on 1st and 2nd grades children's physical activity level and energy expenditure during physical education classes in elementary public schools, in São Paulo, Brazil.
Detailed description
This study is a School-based Randomized Controlled Trial. Three-step cluster sampling was used for subject selection. In the first step, 8 schools in the Vila Mariana district - São Paulo were selected and assigned randomly to physical activity intervention (3 schools) or control condition (5 schools). In the second step, all 48 classes from the 1st and 2nd grades were selected. In the third step, 352 children were randomly selected compose the observational group. In both groups, questionnaire data and SOFIT's observation were collected two times: "pre" (immediately before the intervention), and "post" (immediately after the intervention), with a six weeks interval between them. No educational intervention was taken place in the control schools while the project was running. Afterwards control schools received training.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: Educational InterventionIntervention was applied to classroom teachers by the RRIDA Project team. Training lasted six weeks, 12 hours devoted to physical activity and 18 hours to nutritional content. Modules of educational activities were taught in order to be replicated at PE classes to 1st and 2nd grades' children of three exposed schools. Physical activity module was based on a theoretical approach of physical activity benefits and risks for health, children's physical fitness and activity patterns, physical education and change behavior models. In each meeting the PE professionals, performed PE classes with the classroom teachers as students, focusing in strategies to keep them in movement for the most of PE class time to stimulate students' joint participation instead of individual participation or games. |
| No Intervention | No intervention | –No educational intervention was taken place in the control schools while the project was running. Afterwards, control schools received training. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children from 7 to 10 years of age, enrolled at 1st or 2nd grades of selected schools in Vila Mariana - Sao Paulo.
Key exclusion criteria (1 listed)
- Not have both observations.
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 |
|---|---|---|
| Educational InterventionIntervention was applied to classroom teachers by the multidisciplinary team of the RRIDA Project. Training lasted six weeks, 12 hours devoted to physical activity and 18 hours to nutritional content. Modules of educational activities to classroom teachers were to be replicated at PE classes to children from 1st and 2nd grades of three exposed schools. The physical activity module was based on a theoretical approach of physical activity benefits and risks for health, children's physical fitness and activity patterns, physical education and change behavior models. | Behavioural | Educational Intervention |
Primary outcome
Change in children's Physical Activity Level / Energy Expenditure after an Educational Intervention for classroom teachers.
Time frame: Children's Physical Activity Level / Energy Expenditure were measured before and after an Educational Intervention to classroom teachers, with a six weeks interval.
From eight elementary Public Schools we randomly selected three to receive an educational intervention for teachers. In order to evaluate intervention results, all the 1st and 2nd grades, from exposed and unexposed schools were nominated to have selected children. In each class, eight children were randomly selected. To assess children's level of physical activity, Physical Education classes were recorded. The videotapes analysis set the level of student's physical activity, teacher's attitude, and the class context. The observation instrument used was SOFIT - System for Observing Fitness Instruction Time. We analyzed and discussed the change in children's Physical Activity Level and Energy Expenditure before and after the Educational Intervention to classroom teachers, with a six weeks interval.
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 31 Dec 2013.
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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.
Jose Augusto AC Taddei, MD, Dr PH study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Physical Activity, run by Federal University of São Paulo 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 31 Dec 2013. 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 in children's Physical Activity Level / Energy Expenditure after an Educational Intervention for classroom teachers. (time frame: Children's Physical Activity Level / Energy Expenditure were measured before and after an Educational Intervention to classroom teachers, with a six weeks interval.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2013.