Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognition in Preschool-age Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Activity, Motor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Childcare centers will be randomized to either the treatment or the control intervention.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Data collectors (outcome assessors) collecting cognition outcome variables will be masked.

Study Groups

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Movement and Cognition Intervention group (MAC)

Movement and Cognition group is the behavioral treatment group.

Group Type EXPERIMENTAL

Movement and Cognition Intervention Group

Intervention Type BEHAVIORAL

Preschool centers assigned to the Movement and Cognition (MAC) group will receive the 6-month intervention, which will be implemented 4 days per week. To ensure consistency of intervention delivery, centers will be provided with the MAC modules on a bi-weekly basis. The MAC intervention will be implemented using a train-the-trainer (gradual release) model. This will be a gradual release model, in which interventionist will first serve as a co-provider and will eventually serve in a support role, as providers become primary implementers.

The MAC intervention will consist of gross motor skill curriculum consists of 30 individual lesson plans. The number of days needed to instruct each lesson plan activities ranges between 3 to 5 days. In each lesson, specific instruction and activities are designed to teach fundamental movements (e.g., running, leaping, kicking, jumping, throwing, catching).

Health Tracker group (Control)

Health tracker group is the control group.

Group Type PLACEBO_COMPARATOR

Health Tracker Group (Control Group)

Intervention Type BEHAVIORAL

Preschool centers assigned to the health tracker g group will be asked to maintain their usual daily schedule and to not participate in other physical activity programs during the 6-month intervention.

Interventions

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Movement and Cognition Intervention Group

Preschool centers assigned to the Movement and Cognition (MAC) group will receive the 6-month intervention, which will be implemented 4 days per week. To ensure consistency of intervention delivery, centers will be provided with the MAC modules on a bi-weekly basis. The MAC intervention will be implemented using a train-the-trainer (gradual release) model. This will be a gradual release model, in which interventionist will first serve as a co-provider and will eventually serve in a support role, as providers become primary implementers.

The MAC intervention will consist of gross motor skill curriculum consists of 30 individual lesson plans. The number of days needed to instruct each lesson plan activities ranges between 3 to 5 days. In each lesson, specific instruction and activities are designed to teach fundamental movements (e.g., running, leaping, kicking, jumping, throwing, catching).

Intervention Type BEHAVIORAL

Health Tracker Group (Control Group)

Preschool centers assigned to the health tracker g group will be asked to maintain their usual daily schedule and to not participate in other physical activity programs during the 6-month intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes