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

A Before-school Physical Activity Intervention Program to Improve Attention in Vulnerable Children: The Active-Start Trial

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Attention Deficit Hyperactivity Disorder; Child Behavior; Behavior
• Intervention / Treatment: Behavioral: Active-Start intervention; Behavioral: No Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago de Chile, Chile
    • Universidad de Santiago de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active-Start intervention; Supervised exercise training	Behavioral: Active-Start intervention; 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).; Behavioral: No Intervention; No-exercise
No Intervention: Control group; No-exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selective attention	The D2- Test were used as indicators of selective attention	Change from Baseline and 8-weeks immediately after the interventions ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Academic performance	Was recorded by 2018-2019 year final exam scores	Change from Baseline and 8-weeks immediately after the interventions ends
Executive function	The D2- Test were used as indicators of cognitive flexibility	Change from Baseline and 8-weeks immediately after the interventions ends
Body fat percentage	Was recorded by bioelectrical impedance analysis	Change from Baseline and 8-weeks immediately after the interventions ends
Body mass index	Weight and height were used to calculate BMI (weight in kilograms divided by the square of height in meters).	Change from Baseline and 8-weeks immediately after the interventions ends
Waist circumference	Waist circumference was measured in the horizontal plane at the superior border of the right iliac crest.	Change from Baseline and 8-weeks immediately after the interventions ends
Fat free mass	Was recorded by bioelectrical impedance analysis	Change from Baseline and 8-weeks immediately after the interventions ends
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	Change from Baseline and 8-weeks immediately after the interventions ends
Standing long jump test	The longest attempt from 3 was recorded (centimeters) and multiplied by the body weight to obtain an absolute measurement	Change from Baseline and 8-weeks immediately after the interventions ends
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	Change from Baseline and 8-weeks immediately after the interventions ends
Cardiorespiratory fitness	Cardiorespiratory fitness was assessed through the 20-m shuttle-run test and the total number of completed laps was registered	Change from Baseline and 8-weeks immediately after the interventions ends
Blood pressure	Blood pressure was recorded by a automatic sphygmomanometer with the arm supported at heart level after sitting quietly for 10 min	Change from Baseline and 8-weeks immediately after the interventions ends
Mediterranean diet	This information was self-reported by the children withguided assistance by a trained psychologis with Mediterranean diet (Kidmed) tool	Change from Baseline and 8-weeks immediately after the interventions ends

Collaborators and Investigators

• Sponsor: Universidad Santo Tomas
• Collaborators: Universidad Pública de Navarra
• Investigators: Principal Investigator: Antonio García-Hermoso, PhD, Universidad de Santiago de Chile

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): March 5, 2019

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Prevention; Attention capacity
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: N°: 938 USACH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Scientific background, Objective, Design, and Methods
• IPD Sharing Time Frame: IPD
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No