Physical InactivityACCELERATIONNCT05794360
ACtive Children Enhance LEaRning and AttenTION: A Randomized Controlled Trial (RCT)
A study testing ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) in people with Physical Inactivity, run by University of Houston at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effectiveness of sport-based physical education (PE) curriculum on activity behaviors (moderate to vigorous physical activity and sedentary behavior), executive functions, and academic performance in elementary school-aged children, particularly among low-income ethnic… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- ACtive Children Enhance LEaRning and AttenTION (ACCELERATION)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 29 Jun 2022
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any student enrolled in 3rd or 4th-grade classes were eligible to participate in the study.
- Participation in an extracurricular sports activity wasn't an exclusion criterion for this study.
Who cannot join
- Students were excluded if they had serious physical (e.g., asthma, heart diseases), developmental (e.g., autism, attention-deficit hyperactivity), or learning (e.g., dyslexia, dyscalculia, dysgraphia) disorders that prevented them from participating in intervention activities
- Students who participated in a physical activity intervention within the last 6 months were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial (RCT) of the Impact of School-based Sport Research Program on Children's Physical Activity, Executive Function, and Academic Achievement
The goal of this clinical trial is to test the effectiveness of sport-based physical education (PE) curriculum on activity behaviors (moderate to vigorous physical activity and sedentary behavior), executive functions, and academic performance in elementary school-aged children, particularly among low-income ethnic minorities. The main questions it aims to answer are:
- Whether a school-based sport program can improve child engagement in school-time moderate-to-vigorous physical activity (MVPA) and total daily MVPA, compared to a control group (standard PE class)?
- Whether a school-based sport program can improve child executive functions and academic performance, compared to a control group (standard PE class)?
Read more
Participants randomized to receive the ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) intervention (treatment) received
- 45-minute weekly for 10 weeks soccer (ball mastery exercises) curriculum led by trained PE teachers during the school PE lesson time.
- Homework required practicing learned ball mastery skills daily for 15-20 minutes at home. A required ball was provided to them.
- Virtual parent workshops, which required the attendance of parents of study participants to improve their understanding of all about the program
Researchers will compare the control group, who received a regular PE class curriculum, to see if there are any differences in child activity behaviors, executive functions, and academic performance.
- Conditions
- Physical Inactivity
- Being tested
- ACtive Children Enhance LEaRning and AttenTION (ACCELERATION)
- Keywords
- physical activity, school, cognition, academic performance, executive function
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACtive Children Enhance LEaRning and AttenTION (ACCELERATION)Behavioural
A diverse group of key informants (i.e., PE teachers, school athletic department director) and community stakeholders (i.e., professional soccer coaches, Houston Dynamo Academy director) were engaged to help the research team design, modify, and implement the ACCELERATION curriculum to ensure program relevance and appeal. There are several components that described below make our program design both comprehensive and highly adaptable for optimal reach and effectiveness. These include staff development training, parent workshops, on-site and virtual developmental programs, delivery and implementation support from community stakeholders, online resources, family engagement events, equipment donations to improve activity, and on-going support and mentoring services for parents and school-based educators.
| Study group | Role | What they receive |
|---|---|---|
| ACCELERATION | Experimental | Both study arms occurred during participants' PE class, once a week for 45 minutes for 10 weeks. The ACCELERATION curriculum is designed to improve children's MVPA through learning and practicing new and challenging sport skills in a fun and free-will learning environment that includes not only school but also home environment. The ACCELERATION focuses on introducing the ball to the child at a basic level. Ball mastery is a soccer term that simply refers to the ability to manipulate and play with the ball using all parts of the foot. Since this program was an individual pursuit, not a team endeavor, it was imperative that each student has their own ball during the PE class. The trained undergraduate interns assisted PE teachers to deliver this program to classrooms assigned into the treatment arm. The program trains parents via virtual workshops on delivering the program at home. Receives: Behavioral: ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) |
| Standard PE | No intervention | Classrooms assigned to the control group received a 45-minute weekly regular PE curriculum for 10 weeks designed to meet state-mandated requirements. For the same research school, a standard PE curriculum was also delivered by the same PE teacher who delivered the intervention curriculum. However, additional training and support were not provided to PE teachers for the implementation of a regular PE curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Average Accelerometer-measured MVPA/day at 10 weeks
MVPA behaviors were assessed objectively with accelerometers (GT3X+ Actigraph, Pensacola, FL). Trained research staff instructed the students to wear the accelerometer on the right hip for 8 days, which allowed participant to adapt to wearing the device and to achieve the study goal of 2 valid wear days per child as consistent with school-based evaluations. A valid day were defined as ≥600 minutes wear time per day. Freedson's age specific cut points for children 6 to 18 years old will be used to determine the intensity of activity.
Measured: baseline and post (immediate after 10 weeks of the intervention)
Secondary outcomes (5)
Change from Baseline in the Average Accelerometer-measured Sedentary Time/day at 10 weeks
Sedentary behaviors were assessed objectively with accelerometers (GT3X+ Actigraph, Pensacola, FL). Trained research staff instructed the students to wear the accelerometer on the right hip for 8 days, which allowed participant to adapt to wearing the device and to achieve the study goal of 2 valid wear days per child as consistent with school-based evaluations. A valid day were defined as ≥600 minutes wear time per day. Freedson's age specific cut points for children 6 to 18 years old will be used to determine the intensity of activity.
Measured: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean Dimensional Change Card Sort Test Score at 10 weeks
NIH Toolbox (appropriate for ages 7+) iPad Cognitive Battery utilized to deliver Dimensional Change Card Sort Test. This task measured the cognitive flexibility of children. Children were shown an on-screen target image and instructed to select one of two images matching the target on either shape or color.
Measured: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean Flanker Inhibitory Control and Attention Test Score at 10 weeks
NIH Toolbox (appropriate for ages 7+) iPad Cognitive Battery utilized to deliver Flanker Inhibitory Control and Attention Test. For this task, children were shown an arrow flanked by two additional arrows on each side and instructed to choose an on-screen button matching the direction of the middle arrow.
Measured: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean Picture Sequence Memory Task Score at 10 weeks
NIH Toolbox (appropriate for ages 7+) iPad Cognitive Battery utilized to deliver Picture Sequence Memory Task. Children were shown a narrated sequence of images corresponding to common activities- "How to go to the Park", followed by images depicting children playing on swings, feeding ducks. The same sequence was repeated and the participant was asked to recall the proper sequence.
Measured: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean the State of Texas Assessments of Academic Readiness (STAAR) Standardized Test Scores at 10 weeks
This test emphasizes students' readiness for success in the grade that follows by assessing the knowledge attained in the current grade level. Students in 3rd and 4th grade are tested on the following subjects, reading, mathematics.
Measured: baseline and post (immediate after 10 weeks of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start2 Feb 2022
- Primary completion13 May 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies 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
- Model description
- 2 arm clustered RCT. Two levels of clustering: The students (level 1) will be clustered within the classroom (level 2).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig A Johnston, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794360
- Sponsor's protocol ID
- STUDY00003226
- Acronym
- ACCELERATION
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.
PubMed 21852486Diamond A, Ling DS. Conclusions about interventions, programs, and approaches for improving executive functions that appear justified and those that, despite much hype, do not. Dev Cogn Neurosci. 2016 Apr;18:34-48. doi: 10.1016/j.dcn.2015.11.005. Epub 2015 Dec 7.
PubMed 26749076Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98.
PubMed 23945179Basterfield L, Reilly JK, Pearce MS, Parkinson KN, Adamson AJ, Reilly JJ, Vella SA. Longitudinal associations between sports participation, body composition and physical activity from childhood to adolescence. J Sci Med Sport. 2015 Mar;18(2):178-82. doi: 10.1016/j.jsams.2014.03.005. Epub 2014 Mar 15.
PubMed 24704422Cepni AB, Walsh DW, Kim H, Yoon CY, Hughes SO, Ledoux TA, Johnston CA. Assessing the Efficacy of Sport-Based Physical Education on Children's Activity Behaviors: A Randomized Controlled Trial. J Phys Act Health. 2024 Nov 19;22(2):205-215. doi: 10.1123/jpah.2024-0243. Print 2025 Feb 1.
PubMed 39561744
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) of the Impact of School-based Sport Research Program on Children's Physical Activity, Executive Function, and Academic Achievement
- ClinicalTrials.gov ID
- NCT05794360
- Acronym / sponsor ID
- ACCELERATION / STUDY00003226
- Conditions
- Physical Inactivity
- Keywords
- physical activity, school, cognition, academic performance, executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 3 Apr 2023 (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.
The goal of this clinical trial is to test the effectiveness of sport-based physical education (PE) curriculum on activity behaviors (moderate to vigorous physical activity and sedentary behavior), executive functions, and academic performance in elementary school-aged children, particularly among low-income ethnic minorities. The main questions it aims to answer are:
- Whether a school-based sport program can improve child engagement in school-time moderate-to-vigorous physical activity (MVPA) and total daily MVPA, compared to a control group (standard PE class)?
- Whether a school-based sport program can improve child executive functions and academic performance, compared to a control group (standard PE class)?
Participants randomized to receive the ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) intervention (treatment) received
- 45-minute weekly for 10 weeks soccer (ball mastery exercises) curriculum led by trained PE teachers during the school PE lesson time.
- Homework required practicing learned ball mastery skills daily for 15-20 minutes at home. A required ball was provided to them.
- Virtual parent workshops, which required the attendance of parents of study participants to improve their understanding of all about the program
Researchers will compare the control group, who received a regular PE class curriculum, to see if there are any differences in child activity behaviors, executive functions, and academic performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arm clustered RCT. Two levels of clustering: The students (level 1) will be clustered within the classroom (level 2).
| Arm | Type | Receives |
|---|---|---|
| ACCELERATION | Experimental | Behavioral: ACtive Children Enhance LEaRning and AttenTION (ACCELERATION)Both study arms occurred during participants' PE class, once a week for 45 minutes for 10 weeks. The ACCELERATION curriculum is designed to improve children's MVPA through learning and practicing new and challenging sport skills in a fun and free-will learning environment that includes not only school but also home environment. The ACCELERATION focuses on introducing the ball to the child at a basic level. Ball mastery is a soccer term that simply refers to the ability to manipulate and play with the ball using all parts of the foot. Since this program was an individual pursuit, not a team endeavor, it was imperative that each student has their own ball during the PE class. The trained undergraduate interns assisted PE teachers to deliver this program to classrooms assigned into the treatment arm. The program trains parents via virtual workshops on delivering the program at home. |
| Standard PE | No intervention | –Classrooms assigned to the control group received a 45-minute weekly regular PE curriculum for 10 weeks designed to meet state-mandated requirements. For the same research school, a standard PE curriculum was also delivered by the same PE teacher who delivered the intervention curriculum. However, additional training and support were not provided to PE teachers for the implementation of a regular PE curriculum. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Any student enrolled in 3rd or 4th-grade classes were eligible to participate in the study.
- Participation in an extracurricular sports activity wasn't an exclusion criterion for this study.
Key exclusion criteria (2 listed)
- Students were excluded if they had serious physical (e.g., asthma, heart diseases), developmental (e.g., autism, attention-deficit hyperactivity), or learning (e.g., dyslexia, dyscalculia, dysgraphia) disorders that prevented them from participating in intervention activities
- Students who participated in a physical activity intervention within the last 6 months were excluded.
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 Children Enhance LEaRning and AttenTION (ACCELERATION)A diverse group of key informants (i.e., PE teachers, school athletic department director) and community stakeholders (i.e., professional soccer coaches, Houston Dynamo Academy director) were engaged to help the research team design, modify, and implement the ACCELERATION curriculum to ensure program relevance and appeal. There are several components that described below make our program design both comprehensive and highly adaptable for optimal reach and effectiveness. These include staff development training, parent workshops, on-site and virtual developmental programs, delivery and implementation support from community stakeholders, online resources, family engagement events, equipment donations to improve activity, and on-going support and mentoring services for parents and school-based educators. | Behavioural | ACCELERATION |
Primary outcome
Change from Baseline in the Average Accelerometer-measured MVPA/day at 10 weeks
Time frame: baseline and post (immediate after 10 weeks of the intervention)
MVPA behaviors were assessed objectively with accelerometers (GT3X+ Actigraph, Pensacola, FL). Trained research staff instructed the students to wear the accelerometer on the right hip for 8 days, which allowed participant to adapt to wearing the device and to achieve the study goal of 2 valid wear days per child as consistent with school-based evaluations. A valid day were defined as ≥600 minutes wear time per day. Freedson's age specific cut points for children 6 to 18 years old will be used to determine the intensity of activity.
5 secondary outcomes
Change from Baseline in the Average Accelerometer-measured Sedentary Time/day at 10 weeks
Time frame: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean Dimensional Change Card Sort Test Score at 10 weeks
Time frame: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean Flanker Inhibitory Control and Attention Test Score at 10 weeks
Time frame: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean Picture Sequence Memory Task Score at 10 weeks
Time frame: baseline and post (immediate after 10 weeks of the intervention)
Change from Baseline in the Mean the State of Texas Assessments of Academic Readiness (STAAR) Standardized Test Scores at 10 weeks
Time frame: baseline and post (immediate after 10 weeks of the intervention)
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 9 May 2023.
- Background: PubMed 21852486Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.
- Background: PubMed 26749076Diamond A, Ling DS. Conclusions about interventions, programs, and approaches for improving executive functions that appear justified and those that, despite much hype, do not. Dev Cogn Neurosci. 2016 Apr;18:34-48. doi: 10.1016/j.dcn.2015.11.005. Epub 2015 Dec 7.
- Background: PubMed 23945179Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98.
- Background: PubMed 24704422Basterfield L, Reilly JK, Pearce MS, Parkinson KN, Adamson AJ, Reilly JJ, Vella SA. Longitudinal associations between sports participation, body composition and physical activity from childhood to adolescence. J Sci Med Sport. 2015 Mar;18(2):178-82. doi: 10.1016/j.jsams.2014.03.005. Epub 2014 Mar 15.
- Derived from this study: PubMed 39561744Cepni AB, Walsh DW, Kim H, Yoon CY, Hughes SO, Ledoux TA, Johnston CA. Assessing the Efficacy of Sport-Based Physical Education on Children's Activity Behaviors: A Randomized Controlled Trial. J Phys Act Health. 2024 Nov 19;22(2):205-215. doi: 10.1123/jpah.2024-0243. Print 2025 Feb 1.
- Individual participant dataSharing planned: No
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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.
Craig A Johnston, PhD principal investigator
University of Houston
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 Children Enhance LEaRning and AttenTION (ACCELERATION) in people with Physical Inactivity, run by University of Houston at 1 site in United States.
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 2 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 9 May 2023. 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 United States. 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?
Change from Baseline in the Average Accelerometer-measured MVPA/day at 10 weeks (time frame: baseline and post (immediate after 10 weeks of the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05794360, which also lists 5 linked publications.
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 9 May 2023.