Clinical trial NCT04113707: Building Long-term Academic Success Through Ongoing Fun Fitness Program
Official title: Building Long-term Academic Success Through Ongoing Fun Fitness Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Reading Disorder
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre and post two group intervention
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Change in Movement Assessment Battery for Children-2 (MABC-2) between 3 time points (baseline, 10 weeks, 20 weeks)
timeFrame: Baseline, 10 weeks, 20 weeks
measure: Change in Wechsler Intelligence Scale for Children-5 (WISC-5) between 3 time points (baseline, 10 weeks, 20 weeks)
timeFrame: Baseline, 10 weeks, 20 weeks
measure: Change in Test of Visual Motor Integration (VMI) between 3 time points (baseline, 10 weeks, 20 weeks)
timeFrame: Baseline, 10 weeks, 20 weeks
measure: Change in Behavior Rating Inventory of Executive Function - Parent and Teacher Forms between 3 time points (baseline, 10 weeks, 20 weeks)
timeFrame: Baseline, 10 weeks, 20 weeks
Secondary outcomes:
measure: Change in Renaissance Star Reading Assessment between 3 time points (baseline, 10 weeks, 20 weeks)
timeFrame: Baseline, 10 weeks, 20 weeks
measure: Change in Fitness Gram between 3 time points (baseline, 10 weeks, 20 weeks)
timeFrame: Baseline, 10 weeks, 20 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Odyssey Academy
state: Texas
Study officials:
affiliation: UTMB
name: Karen Ratcliff, PhD
role: PRINCIPAL_INVESTIGATOR
References: