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NCT Number: NCT05949866

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

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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Key information

Conditions

Activity, Motor Behavior Motor Activity

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Movement and Cognition Intervention Group

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 Group)

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.

Primary outcomes

  1. Implementation - Study fidelity

    Time frame: Through out the 6 months intervention

    Process 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.

  2. Implementation - Quality

    Time frame: Through out the 6 months intervention

    This 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).

  3. Implementation - Adaptation

    Time frame: Through out the 6 months intervention

    Weekly 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.

  4. Implementation - Dose delivered

    Time frame: Through out the 6 months intervention

    Process 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.

  5. Implementation - Acceptability

    Time frame: Completion of 6 months intervention

    A 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.

  6. Implementation - Intervention intensity

    Time frame: Through out the 6 months intervention

    Process 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.

Secondary outcomes

  1. Change in preschoolers cognition

    Time frame: Baseline, 3-month and 6-month

    Preschoolers' cognition will be assessed using via the NIH Toolbox for Assessment of Neurological and Behavioral Function on an iPad.

  2. Change in preschoolers' behavioral outcome

    Time frame: Baseline, 3-month and 6-month

    Preschoolers' behavioral outcome will be assessed with the Children's Behavior Questionnaire (Very Short Form).

  3. Change in preschoolers' gross motor skills

    Time frame: Baseline, 3-month and 6-month

    Preschoolers' gross motor skills will be assessed with the Test of Gross Movement Development, 3rd edition (TGMD-3).

  4. Change in preschoolers moderate-to-vigorous physical activity

    Time frame: Baseline, 3-month and 6-month

    Preschoolers physical activity will be assessed with accelerometers for 7 consecutive days at each time frame.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Registry information

Official study title

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

Acronym: P-MAC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2023
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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