Clinical trial NCT05794360: ACtive Children Enhance LEaRning and AttenTION: A Randomized Controlled Trial (RCT)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Keywords: physical activity
school
cognition
academic performance
executive function
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 257
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm clustered RCT. Two levels of clustering: The students (level 1) will be clustered within the classroom (level 2).
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Any student enrolled in 3rd or 4th-grade classes were eligible to participate in the study.
2. Participation in an extracurricular sports activity wasn't an exclusion criterion for this study.

Exclusion Criteria:

1. 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
2. Students who participated in a physical activity intervention within the last 6 months were excluded.

Primary outcomes:
measure: Change from Baseline in the Average Accelerometer-measured MVPA/day at 10 weeks
timeFrame: baseline and post (immediate after 10 weeks of the intervention)
Secondary outcomes:
measure: Change from Baseline in the Average Accelerometer-measured Sedentary Time/day at 10 weeks
timeFrame: baseline and post (immediate after 10 weeks of the intervention)
measure: Change from Baseline in the Mean Dimensional Change Card Sort Test Score at 10 weeks
timeFrame: baseline and post (immediate after 10 weeks of the intervention)
measure: Change from Baseline in the Mean Flanker Inhibitory Control and Attention Test Score at 10 weeks
timeFrame: baseline and post (immediate after 10 weeks of the intervention)
measure: Change from Baseline in the Mean Picture Sequence Memory Task Score at 10 weeks
timeFrame: baseline and post (immediate after 10 weeks of the intervention)
measure: Change from Baseline in the Mean the State of Texas Assessments of Academic Readiness (STAAR) Standardized Test Scores at 10 weeks
timeFrame: baseline and post (immediate after 10 weeks of the intervention)
Other outcomes:
Locations:
city: Houston
country: United States
facility: KIPP Houston Public Schools
state: Texas
Study officials:
affiliation: University of Houston
name: Craig A Johnston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Diamond 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.
citation: Eime 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.
citation: Basterfield 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.