Clinical trial NCT05949866: Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognition in Preschool-age Children
Official title: Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognitive Variables in Preschool-age Children From Low Socioeconomic Backgrounds.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Activity, Motor
Keywords: Physical activity
Gross motor skills
Train-the trainer model
Cognition
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 112
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Childcare centers will be randomized to either the treatment or the control intervention.
Primary purpose: PREVENTION

Brief summary: The goal of this study will be to examine the implementation and preliminary efficacy of a teacher taught gross motor skill-based physical activity (PA) intervention on cognitive variables in low low socio-economic (SES) preschoolers. The movement and cognition intervention will be implemented for 4 days per week for 6 months. Primary outcome variables will be processed evaluation data. Secondary outcome variables will be changes in children's cognitive function (executive functions and memory), gross motor skills, and PA levels at baseline, 3- and 6-month.

Detailed description: The goal of this study will be to examine the implementation and preliminary efficacy of a teacher taught gross motor skill-based physical activity (PA) intervention on cognition in low low socio-economic (SES) preschoolers. Low SES preschool centers (n=4) will be recruited and randomly assigned to either a Movement and Cognition (MAC) or a control group. From each preschool center, preschool-age children will be recruited to participate in their assigned center intervention. The MAC intervention will be implemented for 4 days per week for 6 months. The research team will train the preschool providers to implement the intervention. The control centers will be asked to maintain their usual preschool schedule. Primary outcome variables will be processed evaluation data \[study fidelity (adherence, compliance, and integrity of study design), intervention dosage, acceptability, quality, adaptation\], and will be assessed throughout the 6-month study. Secondary outcome variables will be changes in children's cognitive function (executive functions and memory), gross motor skills, and PA levels at baseline, 3- and 6-month. Aim 1 will examine the implementation of a 6-month teacher taught gross motor skill-based movement intervention in low SES preschoolers. Aim 2 will examine the preliminary efficacy of the MAC intervention on cognition, gross motor skills, and PA in preschoolers. For aim 2, the study will compare the outcome variables of interest between the MAC and the control group.

Eligibility criteria: All children within a childcare center will participate in center's assigned activities. However, children will be individually recruited to participate in the measurement portion of study.

Childcare center will be eligible for study if:

* They have at least 40 (preschool-age) children enrolled
* Have at least 2 full-day preschool classrooms
* Not concurrently participating in other physical activity or gross motor skills programs

Child will be eligible for measurement portion of the study and the parent component if she or he is

- 3 - 5 years old at baseline assessment

Children will be excluded from the measurement portion of the study if they:

* Have conditions limiting participation in gross motor skills or physical activity intervention or the assessment of physical activity
* Plan to move away from the Springfield, MA area within the next 6 months.

Primary outcomes:
measure: Implementation - Study fidelity
timeFrame: Through out the 6 months intervention
measure: Implementation - Quality
timeFrame: Through out the 6 months intervention
measure: Implementation - Adaptation
timeFrame: Through out the 6 months intervention
measure: Implementation - Dose delivered
timeFrame: Through out the 6 months intervention
measure: Implementation - Acceptability
timeFrame: Completion of 6 months intervention
measure: Implementation - Intervention intensity
timeFrame: Through out the 6 months intervention
Secondary outcomes:
measure: Change in preschoolers cognition
timeFrame: Baseline, 3-month and 6-month
measure: Change in preschoolers' behavioral outcome
timeFrame: Baseline, 3-month and 6-month
measure: Change in preschoolers' gross motor skills
timeFrame: Baseline, 3-month and 6-month
measure: Change in preschoolers moderate-to-vigorous physical activity
timeFrame: Baseline, 3-month and 6-month
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts Amherst
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Sofiya Alhassan, PhD
role: PRINCIPAL_INVESTIGATOR
References: