Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognition in Preschool-age Children
- Conditions
- Activity, Motor
- Interventions
- Behavioral: Health Tracker Group (Control Group)Behavioral: Movement and Cognition Intervention Group
- Registration Number
- NCT05949866
- Lead Sponsor
- University of Massachusetts, Amherst
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health Tracker group (Control) Health Tracker Group (Control Group) Health tracker group is the control group. Movement and Cognition Intervention group (MAC) Movement and Cognition Intervention Group Movement and Cognition group is the behavioral treatment group.
- Primary Outcome Measures
Name Time Method Implementation - Study fidelity 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.Implementation - Quality 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).Implementation - Adaptation 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.
Implementation - Acceptability 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.
Implementation - Intervention intensity 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.Implementation - Dose delivered 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.
- Secondary Outcome Measures
Name Time Method Change in preschoolers' gross motor skills Baseline, 3-month and 6-month Preschoolers' gross motor skills will be assessed with the Test of Gross Movement Development, 3rd edition (TGMD-3).
Change in preschoolers cognition 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.
Change in preschoolers' behavioral outcome Baseline, 3-month and 6-month Preschoolers' behavioral outcome will be assessed with the Children's Behavior Questionnaire (Very Short Form).
Change in preschoolers moderate-to-vigorous physical activity Baseline, 3-month and 6-month Preschoolers physical activity will be assessed with accelerometers for 7 consecutive days at each time frame.
Trial Locations
- Locations (1)
University of Massachusetts Amherst
🇺🇸Amherst, Massachusetts, United States