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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02024763
Other study ID # APkit
Secondary ID
Status Completed
Phase N/A
First received December 27, 2013
Last updated December 27, 2013
Start date September 1999
Est. completion date November 2000

Study information

Verified date December 2013
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 352
Est. completion date November 2000
Est. primary completion date November 2000
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria:

- children from 7 to 10 years of age, enrolled at 1st or 2nd grades of selected schools in Vila Mariana - Sao Paulo.

Exclusion Criteria:

- Not have both observations.

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational Intervention
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.

Locations

Country Name City State
Brazil Federal University of Sao Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Children's Physical Activity Level / Energy Expenditure were measured before and after an Educational Intervention to classroom teachers, with a six weeks interval. No
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