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

Primary Purpose

Reading Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motor lab activity
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reading Disorder

Eligibility Criteria

5 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Odyssey Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Motor Lab

Standard of Care

Arm Description

Group A will receive 20 minutes of motor lab intervention daily.

Group B will receive standard of care which will be 20 minutes of reading per day.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 30, 2019
Last Updated
January 31, 2023
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT04113707
Brief Title
Building Long-term Academic Success Through Ongoing Fun Fitness Program
Acronym
BLASTOFF
Official Title
Building Long-term Academic Success Through Ongoing Fun Fitness Program
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: To investigate whether gross motor skills, fine motor skills, and physical fitness, predict executive function skills. To determine the relationship between these variables and academic performance. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reading Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pre and post two group intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor Lab
Arm Type
Experimental
Arm Description
Group A will receive 20 minutes of motor lab intervention daily.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Group B will receive standard of care which will be 20 minutes of reading per day.
Intervention Type
Behavioral
Intervention Name(s)
Motor lab activity
Intervention Description
fitness, gross motor, fine motor, and motor coordination activities
Primary Outcome Measure Information:
Title
Change in Movement Assessment Battery for Children-2 (MABC-2) between 3 time points (baseline, 10 weeks, 20 weeks)
Description
Motor skills test which provides standard scores from 1-19 where higher scores represent better performance.
Time Frame
Baseline, 10 weeks, 20 weeks
Title
Change in Wechsler Intelligence Scale for Children-5 (WISC-5) between 3 time points (baseline, 10 weeks, 20 weeks)
Description
Measures of executive function which provides scale scores from 1-19 where higher scores represent better performance.
Time Frame
Baseline, 10 weeks, 20 weeks
Title
Change in Test of Visual Motor Integration (VMI) between 3 time points (baseline, 10 weeks, 20 weeks)
Description
Measures of visual perception and visual motor skills providing scores from 45-155 where higher scores represent better performance.
Time Frame
Baseline, 10 weeks, 20 weeks
Title
Change in Behavior Rating Inventory of Executive Function - Parent and Teacher Forms between 3 time points (baseline, 10 weeks, 20 weeks)
Description
Measure of behavioral executive function with score within the range of 30-90 where scores >60 represent poorer performance.
Time Frame
Baseline, 10 weeks, 20 weeks
Secondary Outcome Measure Information:
Title
Change in Renaissance Star Reading Assessment between 3 time points (baseline, 10 weeks, 20 weeks)
Description
Reading assessment with domain scores ranging from 0-99 where higher scores represent stronger performance.
Time Frame
Baseline, 10 weeks, 20 weeks
Title
Change in Fitness Gram between 3 time points (baseline, 10 weeks, 20 weeks)
Description
fitness assessment with scores falling within either healthy fitness zone, needs improvement zone, or health risk zone.
Time Frame
Baseline, 10 weeks, 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Ratcliff, PhD
Organizational Affiliation
UTMB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odyssey Academy
City
Galveston
State/Province
Texas
ZIP/Postal Code
77551
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Building Long-term Academic Success Through Ongoing Fun Fitness Program

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