Physical ActivityActive-StarNCT03893149
Attention Capacity and Before-school Physical Activity Intervention Program
A study testing Active-Start intervention in people with Physical Activity and Behavior, run by Universidad Santo Tomas at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Behavior, Child Behavior
- What is being tested?
- Active-Start intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChile
- Study dates
- 3 Mar 2018to 5 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children with some physical pathology or medical contraindication to perform physical exercise
- Diagnosed with learning disabilities or mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Active-Start intervention, No Intervention
- Keywords
- Exercise, Prevention, Attention capacity
- Medical subject headings
- Motor Activity, Behavior, Child Behavior, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active-Start interventionBehavioural
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 InterventionBehavioural
No-exercise
| Study group | Role | What they receive |
|---|---|---|
| Active-Start intervention | Experimental | Supervised exercise training Receives: Behavioral: Active-Start intervention; Behavioral: No Intervention |
| Control group | No intervention | No-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective attention
The D2- Test were used as indicators of selective attention
Measured: Change from Baseline and 8-weeks immediately after the interventions ends
Secondary outcomes (12)
Academic performance
Was recorded by 2018-2019 year final exam scores
Measured: Change from Baseline and 8-weeks immediately after the interventions ends
Executive function
The D2- Test were used as indicators of cognitive flexibility
Measured: Change from Baseline and 8-weeks immediately after the interventions ends
Body fat percentage
Was recorded by bioelectrical impedance analysis
Measured: 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).
Measured: 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.
Measured: Change from Baseline and 8-weeks immediately after the interventions ends
Fat free mass
Was recorded by bioelectrical impedance analysis
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline and 8-weeks immediately after the interventions ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start3 Mar 2018
- Primary completion1 Dec 2018
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pública de Navarra
- Responsible party
- Sponsor
- Investigators
- Antonio García-Hermoso, PhD, Principal investigator, Universidad de Santiago de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893149
- Sponsor's protocol ID
- N°: 938 USACH
- Acronym
- Active-Star
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientific background, Objective, Design, and Methods
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Before-school Physical Activity Intervention Program to Improve Attention in Vulnerable Children: The Active-Start Trial
- ClinicalTrials.gov ID
- NCT03893149
- Acronym / sponsor ID
- Active-Star / N°: 938 USACH
- Keywords
- Exercise, Prevention, Attention capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidad Santo TomasUniversity, hospital or other
- Collaborators
- Universidad Pública de Navarra
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-Start intervention | Experimental | Behavioral: Active-Start intervention, Behavioral: No InterventionSupervised exercise training |
| Control group | No intervention | –No-exercise |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Children with some physical pathology or medical contraindication to perform physical exercise
- Diagnosed with learning disabilities or mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active-Start interventionSupervised 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). | Behavioural | Active-Start intervention |
| No InterventionNo-exercise | Behavioural | Active-Start intervention |
Primary outcome
Selective attention
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
The D2- Test were used as indicators of selective attention
12 secondary outcomes
Academic performance
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Executive function
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Body fat percentage
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Body mass index
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Waist circumference
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Fat free mass
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Muscular strength
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Standing long jump test
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
4x10-m shuttle-run test
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Cardiorespiratory fitness
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Blood pressure
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Mediterranean diet
Time frame: Change from Baseline and 8-weeks immediately after the interventions ends
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: Yes. Scientific background, Objective, Design, and Methods
Related trials for Physical Activity
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Recruiting
Stress Modulation and Dynamic Balance
Stress
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio García-Hermoso, PhD principal investigator
Universidad de Santiago de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active-Start intervention in people with Physical Activity and Behavior, run by Universidad Santo Tomas at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective attention (time frame: Change from Baseline and 8-weeks immediately after the interventions ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.