ACtive Children Enhance LEaRning and AttenTION: A Randomized Controlled Trial (RCT)

NCT05794360 | Completed

• 1 other identifier: STUDY00003226
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity

Keywords

physical activity; school; cognition; academic performance; executive function

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  baseline and post (immediate after 10 weeks of the intervention)

• Change from Baseline in the Mean Picture Sequence Memory Task Score at 10 weeks

  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

  baseline and post (immediate after 10 weeks of the intervention)

Study Arms (2)

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.

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.

Interventions

ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) BEHAVIORAL

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.

ACCELERATION

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any student enrolled in 3rd or 4th-grade classes were eligible to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

KIPP Houston Public Schools

Houston, Texas, 77099, United States

Location

Related Publications (4)

• 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.

  PMID: 21852486 BACKGROUND

• 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.

  PMID: 26749076 BACKGROUND

• 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.

  PMID: 23945179 BACKGROUND

• 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.

  PMID: 24704422 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Interventions

Acceleration

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motion; Physical Phenomena

Study Officials

• Craig A Johnston, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arm clustered RCT. Two levels of clustering: The students (level 1) will be clustered within the classroom (level 2).

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: April 3, 2023
• Study Start: February 2, 2022
• Primary Completion: May 13, 2022
• Study Completion: June 29, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)