Activity, MotorP-MACNCT05949866
Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognition in Preschool-age Children
A study testing Movement and Cognition Intervention Group in people with Activity, Motor, run by University of Massachusetts, Amherst at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Activity, Motor
- What is being tested?
- Movement and Cognition Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Amherst
Amherst, Massachusetts, 01003
About this study
Official title: Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognitive Variables in Preschool-age Children From Low Socioeconomic Backgrounds.
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.
Read the 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.
- Conditions
- Activity, Motor
- Being tested
- Movement and Cognition Intervention Group, Health Tracker Group (Control Group)
- Keywords
- Physical activity, Gross motor skills, Train-the trainer model, Cognition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement and Cognition Intervention GroupBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Movement and Cognition Intervention group (MAC) | Experimental | Movement and Cognition group is the behavioral treatment group. Receives: Behavioral: Movement and Cognition Intervention Group |
| Health Tracker group (Control) | Placebo comparator | Health tracker group is the control group. Receives: Behavioral: Health Tracker Group (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through out the 6 months intervention
Secondary outcomes (4)
Change in preschoolers cognition
Preschoolers' cognition will be assessed using via the NIH Toolbox for Assessment of Neurological and Behavioral Function on an iPad.
Measured: Baseline, 3-month and 6-month
Change in preschoolers' behavioral outcome
Preschoolers' behavioral outcome will be assessed with the Children's Behavior Questionnaire (Very Short Form).
Measured: Baseline, 3-month and 6-month
Change in preschoolers' gross motor skills
Preschoolers' gross motor skills will be assessed with the Test of Gross Movement Development, 3rd edition (TGMD-3).
Measured: Baseline, 3-month and 6-month
Change in preschoolers moderate-to-vigorous physical activity
Preschoolers physical activity will be assessed with accelerometers for 7 consecutive days at each time frame.
Measured: Baseline, 3-month and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Aug 2023
- Primary completion30 May 2025
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activity, MotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Childcare centers will be randomized to either the treatment or the control intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofiya Alhassan, University of Massachusetts, Amherst
- Investigators
- Sofiya Alhassan, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949866
- Sponsor's protocol ID
- 1R21HD108125-01A1
- Acronym
- P-MAC
- Status last verified
- Mar 2025
- First submitted
- 15 Jun 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Fidelity of a Gross Motor-based Physical Activity Intervention on Cognitive Variables in Preschool-age Children From Low Socioeconomic Backgrounds.
- ClinicalTrials.gov ID
- NCT05949866
- Acronym / sponsor ID
- P-MAC / 1R21HD108125-01A1
- Conditions
- Activity, Motor
- Keywords
- Physical activity, Gross motor skills, Train-the trainer model, Cognition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Childcare centers will be randomized to either the treatment or the control intervention.
| Arm | Type | Receives |
|---|---|---|
| Movement and Cognition Intervention group (MAC) | Experimental | Behavioral: Movement and Cognition Intervention GroupMovement and Cognition group is the behavioral treatment group. |
| Health Tracker group (Control) | Placebo comparator | Behavioral: Health Tracker Group (Control Group)Health tracker group is the control group. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement and Cognition Intervention GroupPreschool 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). | Behavioural | Movement and Cognition Intervention group (MAC) |
| 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. | Behavioural | Health Tracker group (Control) |
Primary outcome
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.
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).
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.
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.
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.
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.
4 secondary outcomes
Change in preschoolers cognition
Time frame: Baseline, 3-month and 6-month
Change in preschoolers' behavioral outcome
Time frame: Baseline, 3-month and 6-month
Change in preschoolers' gross motor skills
Time frame: Baseline, 3-month and 6-month
Change in preschoolers moderate-to-vigorous physical activity
Time frame: Baseline, 3-month and 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofiya Alhassan, PhD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement and Cognition Intervention Group in people with Activity, Motor, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation - Study fidelity (time frame: Through out the 6 months intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.