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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05949866
Acronym
P-MAC
Enrollment
112
Registered
2023-07-18
Start date
2023-08-01
Completion date
2025-12-30
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Activity, Motor

Keywords

Physical activity, Gross motor skills, Train-the trainer model, Cognition

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.

Interventions

BEHAVIORALMovement 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).

BEHAVIORALHealth 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.

Sponsors

University of Massachusetts, Amherst
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Implementation - Intervention intensityThrough out the 6 months interventionProcess evaluation data on the intervention intensity. Children in both the Movement and Cognition (MAC) and control (CON) centers will be asked to wear the activity accelerometer on one random day per week to assess the intervention intensity.
Implementation - QualityThrough out the 6 months interventionThis will be assessed how well intervention training was delivered to providers & research staff. On 2 randomly selected days per week within the treatment preschool center classrooms, research staff members will directly observe the intervention and use a semi-structured questionnaire (created by research PI) to collect information on intervention study fidelity (quality of the intervention implementation by classroom providers).
Implementation - AdaptationThrough out the 6 months interventionWeekly survey with researchers and providers during 6-month program at both Movement and Cognition (MAC) and control (CON) centers to determine if there was any modification to either the MAC or the CON program.
Implementation - Dose deliveredThrough out the 6 months interventionProcess evaluation data on how much of the intervention was delivered. This will be assessed using the weekly log of Movement and Cognition (MAC) implementation by research staff and childcare providers.
Implementation - AcceptabilityCompletion of 6 months interventionA semi-structured questionnaire with providers at the completion of 6-month intervention in the Movement and Cognition (MAC) group. This will address the acceptability and satisfaction of the overall program and the individual intervention components.
Implementation - Study fidelityThrough out the 6 months interventionProcess evaluation data, specifically the study fidelity of the intervention, will be assessed. On 2 randomly selected days per week within the treatment preschool center classrooms, research staff members will directly observe the intervention and use a semi-structured questionnaire (created by research PI) to collect information on intervention study fidelity (are the intervention activities being implemented as designed). In addition, 1 day per week, research staff members will directly observe the control center and use a semi-structured questionnaire to assessment of control (CON) school activities.

Secondary

MeasureTime frameDescription
Change in preschoolers' behavioral outcomeBaseline, 3-month and 6-monthPreschoolers' behavioral outcome will be assessed with the Children's Behavior Questionnaire (Very Short Form).
Change in preschoolers' gross motor skillsBaseline, 3-month and 6-monthPreschoolers' gross motor skills will be assessed with the Test of Gross Movement Development, 3rd edition (TGMD-3).
Change in preschoolers moderate-to-vigorous physical activityBaseline, 3-month and 6-monthPreschoolers physical activity will be assessed with accelerometers for 7 consecutive days at each time frame.
Change in preschoolers cognitionBaseline, 3-month and 6-monthPreschoolers' cognition will be assessed using via the NIH Toolbox for Assessment of Neurological and Behavioral Function on an iPad.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026