Building Long-term Academic Success Through Ongoing Fun Fitness Program (BLASTOFF)

The purpose of the research study is to investigate if daily motor activities, including fitness activities, gross motor skills, fine motor skills, and motor coordination activities result in physiological, cognitive, and behavioral benefits to children at Odyssey Academy. The study will compare students' performance after intervention by comparing an intervention period to a standard care period, and comparing intervention students to students engaged in standard school activities in the area of academic performance.

Study Overview

• Status: Active, not recruiting
• Conditions: Reading Disorder
• Intervention / Treatment: Behavioral: Motor lab activity

Detailed Description

The objective of this study is to track if daily participation in motor lab activities for school age children improves their academic performance. Academic performance is associated with motor skills, coordination, and executive function. Our objectives are to determine if daily participation in motor lab activities changes these skills, to better understand these relationships, track outcomes of children participating in motor lab intervention compared to non-intervention and children receiving standard level of care in the school, and to be able to follow the intervention students over time.

The specific aims of the study are:

1. To investigate whether gross motor skills, fine motor skills, and physical fitness, predict executive function skills.
2. To determine the relationship between these variables and academic performance.
3. To examine the relationship between participation in motor lab activities and measures of change in fitness, gross motor skills, fine motor skills, executive function, and academic performance.
4. To evaluate if participation in daily motor lab activities predicts fitness level, gross motor skills, fine motor skills, executive function, and academic success at the end of the school year and in the next school year.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77551
      • Odyssey Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• students in grades kindergarten through fourth grade,
• students below grade level in reading
• in Odyssey Academy's reading program

Exclusion Criteria:

• students that are not part of the specialized reading program at Odyssey Academy
• are unwilling to participate in the motor lab intervention
• lack conversational ability in the use of the English language.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor Lab; Group A will receive 20 minutes of motor lab intervention daily.	Behavioral: Motor lab activity; fitness, gross motor, fine motor, and motor coordination activities
No Intervention: Standard of Care; Group B will receive standard of care which will be 20 minutes of reading per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Movement Assessment Battery for Children-2 (MABC-2) between 3 time points (baseline, 10 weeks, 20 weeks)	Motor skills test which provides standard scores from 1-19 where higher scores represent better performance.	Baseline, 10 weeks, 20 weeks
Change in Wechsler Intelligence Scale for Children-5 (WISC-5) between 3 time points (baseline, 10 weeks, 20 weeks)	Measures of executive function which provides scale scores from 1-19 where higher scores represent better performance.	Baseline, 10 weeks, 20 weeks
Change in Test of Visual Motor Integration (VMI) between 3 time points (baseline, 10 weeks, 20 weeks)	Measures of visual perception and visual motor skills providing scores from 45-155 where higher scores represent better performance.	Baseline, 10 weeks, 20 weeks
Change in Behavior Rating Inventory of Executive Function - Parent and Teacher Forms between 3 time points (baseline, 10 weeks, 20 weeks)	Measure of behavioral executive function with score within the range of 30-90 where scores >60 represent poorer performance.	Baseline, 10 weeks, 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Renaissance Star Reading Assessment between 3 time points (baseline, 10 weeks, 20 weeks)	Reading assessment with domain scores ranging from 0-99 where higher scores represent stronger performance.	Baseline, 10 weeks, 20 weeks
Change in Fitness Gram between 3 time points (baseline, 10 weeks, 20 weeks)	fitness assessment with scores falling within either healthy fitness zone, needs improvement zone, or health risk zone.	Baseline, 10 weeks, 20 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Karen Ratcliff, PhD, UTMB

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: 19-0180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No