NCT05949866

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

Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognitive Variables in Preschool-age Children From Low Socioeconomic Backgrounds.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University of Massachusetts, Amherst · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Activity, Motor

Interventions

Type	Name	Description
BEHAVIORAL	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).
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-05-30
• Completion: 2025-12-30
• First posted: 2023-07-18
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States