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Attention Capacity and Before-school Physical Activity Intervention Program (Active-Star)

Primary Purpose

Physical Activity, Behavior, Child Behavior

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Active-Start intervention
No Intervention
Sponsored by
Universidad Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity focused on measuring Exercise, Prevention, Attention capacity

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All students in fourth grade (aged 8-10 years)
  • Children's parents/caregivers will give their written consent to the children's participation.
  • Collaboration in the family to respond to questionnaires

Exclusion Criteria:

  • Children with some physical pathology or medical contraindication to perform physical exercise
  • Diagnosed with learning disabilities or mental disorders

Sites / Locations

  • Universidad de Santiago de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active-Start intervention

Control group

Arm Description

Supervised exercise training

No-exercise

Outcomes

Primary Outcome Measures

Selective attention
The D2- Test were used as indicators of selective attention

Secondary Outcome Measures

Academic performance
Was recorded by 2018-2019 year final exam scores
Executive function
The D2- Test were used as indicators of cognitive flexibility
Body fat percentage
Was recorded by bioelectrical impedance analysis
Body mass index
Weight and height were used to calculate BMI (weight in kilograms divided by the square of height in meters).
Waist circumference
Waist circumference was measured in the horizontal plane at the superior border of the right iliac crest.
Fat free mass
Was recorded by bioelectrical impedance analysis
Muscular strength
The handgrip test, each child performed the test twice with each hand, and the maximum value of each hand was taken and averaged
Standing long jump test
The longest attempt from 3 was recorded (centimeters) and multiplied by the body weight to obtain an absolute measurement
4x10-m shuttle-run test
The speed-agility was assessed twice using the 4 x 10-m shuttle-run test and the fastest completion time (seconds) was recorded
Cardiorespiratory fitness
Cardiorespiratory fitness was assessed through the 20-m shuttle-run test and the total number of completed laps was registered
Blood pressure
Blood pressure was recorded by a automatic sphygmomanometer with the arm supported at heart level after sitting quietly for 10 min
Mediterranean diet
This information was self-reported by the children withguided assistance by a trained psychologis with Mediterranean diet (Kidmed) tool

Full Information

First Posted
March 22, 2019
Last Updated
March 25, 2019
Sponsor
Universidad Santo Tomas
Collaborators
Universidad Pública de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT03893149
Brief Title
Attention Capacity and Before-school Physical Activity Intervention Program
Acronym
Active-Star
Official Title
A Before-school Physical Activity Intervention Program to Improve Attention in Vulnerable Children: The Active-Start Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 3, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
March 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Santo Tomas
Collaborators
Universidad Pública de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Despite the evidence and the potential of physical activity related to cognition and academic performance in children, the effects of a before-school physical activity program on these parameters remains unknown.
Detailed Description
Despite public health concerns and the extensively documented health benefits of physical activity, a large proportion of Chilean children do not meet the physical activity recommendations (Aguilar-Farias et al., 2018). Since most children spend a majority of their waking hours at school, this environment is appropriate for the implementation of preventive interventions, particularly those that include activities promoting physical activity (Naylor & McKay, 2009). With the absence of opportunities for physical activity during the school day, before-school programs have become a popular option to help children increasing their physical activity levels (Stylianou, van der Mars, et al., 2016). Although several recent studies support a positive effect of before school-based physical activity on health (Westcott, Puhala, Colligan, Loud, & Cobbett, 2015), less literature has evaluate the cognitive outcomes (Stylianou, Kulinna, et al., 2016) such as attention capacity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Behavior, Child Behavior, Attention Deficit Hyperactivity Disorder
Keywords
Exercise, Prevention, Attention capacity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active-Start intervention
Arm Type
Experimental
Arm Description
Supervised exercise training
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No-exercise
Intervention Type
Behavioral
Intervention Name(s)
Active-Start intervention
Intervention Description
Supervised exercise training. The intervention is a physical activity intervention that consist of 5 times per week before starting the first school-class (8:00-8:30 a.m.), 5 times per week. Each session was previously planned and described in a manual dedicated to the study. These sessions were designed by the research team and delivered by a graduate in Sport The intervention program included sports games adapted to the age of the participants, playground games, dance and other recreational activities. The intensity of the main part of the sessions was moderate-to-vigorous according to a previous study and this intensity was confirmed by accelerometry. Also, different activities favoring social interactions were designed to facilitate the interactions between the participants at the end of the sessions (cold-down).
Intervention Type
Behavioral
Intervention Name(s)
No Intervention
Intervention Description
No-exercise
Primary Outcome Measure Information:
Title
Selective attention
Description
The D2- Test were used as indicators of selective attention
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Secondary Outcome Measure Information:
Title
Academic performance
Description
Was recorded by 2018-2019 year final exam scores
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Executive function
Description
The D2- Test were used as indicators of cognitive flexibility
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Body fat percentage
Description
Was recorded by bioelectrical impedance analysis
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Body mass index
Description
Weight and height were used to calculate BMI (weight in kilograms divided by the square of height in meters).
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Waist circumference
Description
Waist circumference was measured in the horizontal plane at the superior border of the right iliac crest.
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Fat free mass
Description
Was recorded by bioelectrical impedance analysis
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Muscular strength
Description
The handgrip test, each child performed the test twice with each hand, and the maximum value of each hand was taken and averaged
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Standing long jump test
Description
The longest attempt from 3 was recorded (centimeters) and multiplied by the body weight to obtain an absolute measurement
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
4x10-m shuttle-run test
Description
The speed-agility was assessed twice using the 4 x 10-m shuttle-run test and the fastest completion time (seconds) was recorded
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Cardiorespiratory fitness
Description
Cardiorespiratory fitness was assessed through the 20-m shuttle-run test and the total number of completed laps was registered
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Blood pressure
Description
Blood pressure was recorded by a automatic sphygmomanometer with the arm supported at heart level after sitting quietly for 10 min
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends
Title
Mediterranean diet
Description
This information was self-reported by the children withguided assistance by a trained psychologis with Mediterranean diet (Kidmed) tool
Time Frame
Change from Baseline and 8-weeks immediately after the interventions ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All students in fourth grade (aged 8-10 years) Children's parents/caregivers will give their written consent to the children's participation. Collaboration in the family to respond to questionnaires Exclusion Criteria: Children with some physical pathology or medical contraindication to perform physical exercise Diagnosed with learning disabilities or mental disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio García-Hermoso, PhD
Organizational Affiliation
Universidad de Santiago de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Santiago de Chile
City
Santiago de Chile
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Scientific background, Objective, Design, and Methods
IPD Sharing Time Frame
IPD
IPD Sharing URL
https://www.dropbox.com/home/SABE/ActiveStars

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Attention Capacity and Before-school Physical Activity Intervention Program

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