- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403996
Effects of an Active Break Program at Primary School (Activa-Mente)
December 27, 2023 updated by: Nicolas Aguilar Farias, Universidad de La Frontera
Effects of an Active Break Program at School on Physical Activity and On-task Behavior in Children From 6 to 12 Years Old
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicolas Aguilar Farias, PhD
- Phone Number: 56945082634
- Email: nicolas.aguilar@ufrontera.cl
Study Locations
-
-
-
Valparaíso, Chile
- Facultad de Ciencias de la Actividad Física y del Deporte
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Activa-Mente (Intervention)
The active break program involves the presentation of video (4.5 min) with moderate-to-vigorous physical activities.
These active breaks will be performed 6 times per day during 6 weeks.
|
Active break program
|
No Intervention: Control group
This group of students will not be exposed to the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: 6 weeks
|
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
|
On-task behavior
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity enjoyment
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tomas Reyes, PhD, Playa Ancha University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
October 20, 2023
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
May 31, 2022
First Submitted That Met QC Criteria
May 31, 2022
First Posted (Actual)
June 3, 2022
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 27, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- UPLA-005-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The anonymized and raw data supporting the conclusions of this study will be made available by the principal investigator, upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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