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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05403996
Other study ID # UPLA-005-2022
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date April 30, 2024

Study information

Verified date December 2023
Source Universidad de La Frontera
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children.


Description:

The protocol will include third and fourth-grade students (children aged 8 to 10 years) from elementary schools in the Valparaíso Region, Chile. Four school classes from two schools (intervention and control school) will be included. The intervention school will carry out the active break program, ACTIVA-MENTE This program consists of the application of a 4-and-a-half-minute video with moderate to vigorous-intensity physical activity. These breaks will take place 6 times a day in classes for 6 weeks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date April 30, 2024
Est. primary completion date October 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 10 Years
Eligibility Inclusion Criteria: - Schoolchildren aged 8 to 10 years old (third to fourth grade of primary education). Exclusion Criteria: - Children with school attendance lower than 90 per cent (excluded from data analysis). - Any medical condition that impedes physical activity breaks.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Activa-Mente
Active break program

Locations

Country Name City State
Chile Facultad de Ciencias de la Actividad Física y del Deporte Valparaíso

Sponsors (3)

Lead Sponsor Collaborator
Universidad de La Frontera Playa Ancha University, Universidad Metropolitana de Ciencias de la Educacion

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity Physical activity will be measured with waist-worn ActiGraph GT3X+ accelerometers for seven days. Physical activity intensities will be derived from the accelerometer counts. Evenson cut points will be used to classify counts into physical activity intensities. Physical activity will be classified as light, moderate-to-vigorous and total physical activity. 6 weeks
Primary On-task behavior The Direct Behaviour Rating Scale will be used to measure on-task behavior at the individual level. This scale measures academically engaged, respectful and disruptive behavior. For each domain, the scale uses a per cent grading system in which 0% indicates 'never' while 100% indicates 'always'. At the group level, the Classroom Behaviour and Assets Survey will be used teachers who will be asked to indicate the proportion of the class displaying on-task behavior as defined by the individual behavior tool. Response options include: 0 (0 students), 1 (1-2 students), 2 (a few students), 3 (about ¼ of the class), 4 (about ½ of the class), 5 (about ¾ of the class), 6 (most of the class), and 7 (all of the class). 6 weeks
Secondary Physical activity enjoyment The Physical Activity Enjoyment Scale (PACES) will be used to measure enjoyment during the active breaks. Each of the 14 items of this instrument includes a Likert-type scale that ranges from 1 (Disagree a lot) to 5 (Agree a lot). 6 weeks
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