Clinical trial NCT03893149: Attention Capacity and Before-school Physical Activity Intervention Program
Official title: A Before-school Physical Activity Intervention Program to Improve Attention in Vulnerable Children: The Active-Start Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Behavior
Child Behavior
Attention Deficit Hyperactivity Disorder
Keywords: Exercise
Prevention
Attention capacity
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Universidad Pública de Navarra
First posted: 2019-03-28
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Selective attention
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
Secondary outcomes:
measure: Academic performance
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Executive function
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Body fat percentage
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Body mass index
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Waist circumference
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Fat free mass
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Muscular strength
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Standing long jump test
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: 4x10-m shuttle-run test
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Cardiorespiratory fitness
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Blood pressure
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
measure: Mediterranean diet
timeFrame: Change from Baseline and 8-weeks immediately after the interventions ends
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Universidad de Santiago de Chile
Study officials:
affiliation: Universidad de Santiago de Chile
name: Antonio García-Hermoso, PhD
role: PRINCIPAL_INVESTIGATOR
References: