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

NCT05949866 | Active Not Recruiting

• 1 other identifier: 1R21HD108125-01A1
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Activity, Motor

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Implementation - Study fidelity

  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.

  Through out the 6 months intervention

• Implementation - Quality

  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).

  Through out the 6 months intervention

• Implementation - Adaptation

  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.

  Through out the 6 months intervention

• Implementation - Dose delivered

  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.

  Through out the 6 months intervention

• Implementation - Acceptability

  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.

  Completion of 6 months intervention

• Implementation - Intervention intensity

  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.

  Through out the 6 months intervention

Secondary Outcomes (4)

• Change in preschoolers cognition

  Baseline, 3-month and 6-month

• Change in preschoolers' behavioral outcome

  Baseline, 3-month and 6-month

• Change in preschoolers' gross motor skills

  Baseline, 3-month and 6-month

• Change in preschoolers moderate-to-vigorous physical activity

  Baseline, 3-month and 6-month

Study Arms (2)

Movement and Cognition Intervention group (MAC)

EXPERIMENTAL

Movement and Cognition group is the behavioral treatment group.

Behavioral: Movement and Cognition Intervention Group

Health Tracker group (Control)

PLACEBO COMPARATOR

Health tracker group is the control group.

Behavioral: Health Tracker Group (Control Group)

Interventions

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).

Movement and Cognition Intervention group (MAC)

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.

Health Tracker group (Control)

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead

Study Sites (1)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Movement; Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sofiya Alhassan, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collectors (outcome assessors) collecting cognition outcome variables will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 18, 2023
• Study Start: August 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-03

Locations

US (1)