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

Activity, Motor Clinical Trial

— P-MAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05949866
• Other study ID #: 1R21HD108125-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Activity, Motor

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	University of Massachusetts Amherst	Amherst	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in preschoolers cognition	Preschoolers' cognition will be assessed using via the NIH Toolbox for Assessment of Neurological and Behavioral Function on an iPad.	Baseline, 3-month and 6-month
Secondary	Change in preschoolers' behavioral outcome	Preschoolers' behavioral outcome will be assessed with the Children's Behavior Questionnaire (Very Short Form).	Baseline, 3-month and 6-month
Secondary	Change in preschoolers' gross motor skills	Preschoolers' gross motor skills will be assessed with the Test of Gross Movement Development, 3rd edition (TGMD-3).	Baseline, 3-month and 6-month
Secondary	Change in preschoolers moderate-to-vigorous physical activity	Preschoolers physical activity will be assessed with accelerometers for 7 consecutive days at each time frame.	Baseline, 3-month and 6-month