Attention Capacity and Before-school Physical Activity Intervention Program

Physical Activity Clinical Trial

— Active-Star  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893149
• Other study ID #: N°: 938 USACH
• Status: Completed
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: March 5, 2019

Study information

• Verified date: March 2019
• Source: Universidad Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 5, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Behavior
• Child Behavior
• Physical Activity

Intervention

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).
• No Intervention
No-exercise

Locations

Country	Name	City	State
Chile	Universidad de Santiago de Chile	Santiago de Chile

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Santo Tomas	Universidad Pública de Navarra

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Selective attention	The D2- Test were used as indicators of selective attention	Change from Baseline and 8-weeks immediately after the interventions ends
Secondary	Academic performance	Was recorded by 2018-2019 year final exam scores	Change from Baseline and 8-weeks immediately after the interventions ends
Secondary	Executive function	The D2- Test were used as indicators of cognitive flexibility	Change from Baseline and 8-weeks immediately after the interventions ends
Secondary	Body fat percentage	Was recorded by bioelectrical impedance analysis	Change from Baseline and 8-weeks immediately after the interventions ends
Secondary	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
Secondary	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
Secondary	Fat free mass	Was recorded by bioelectrical impedance analysis	Change from Baseline and 8-weeks immediately after the interventions ends
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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