ExerciseActive PlayNCT05744791
Active Play Intervention for Preschoolers
A study testing Active Play planned movement program in people with Exercise, run by Auburn University at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to examine the effects of a planned movement in preschool-aged children. The main question is to determine What are the effects of a planned movement program on physical activity, body composition, fundamental motor skills, and time on task in preschool children aged 3-5… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Active Play planned movement program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 3 to 5 years of age
- attending one of the preschools 5 days a week.
Who cannot join
- less than 3 years of age
- greater than 5 years of age at the beginning of the study
- attends the preschool 2 days or 3 days a week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of a Planned Movement and Physical Activity Program on the Physiological and Psychology Parameters in a Pediatric Population
The goal of this randomized clinical trial is to examine the effects of a planned movement in preschool-aged children. The main question is to determine
- What are the effects of a planned movement program on physical activity, body composition, fundamental motor skills, and time on task in preschool children aged 3-5 years?
Researchers will compare a planned movement program to a control group, where current instruction is implemented.
Read the detailed description
A majority of preschool children do not participate in the recommended levels of physical activity and are deficient in fundamental motor skills. These deficits may also impact body composition. Preschool teachers serve as the gateway to providing physical activity opportunities at preschool but many fail to do so. As play is developmentally appropriate for preschools and part of many curriculums adding active elements to play may be a feasible solution for teachers to implement physical activity opportunities. This project will evaluate the effect of a planned movement program that incorporates elements of active play on preschoolers' body composition, physical activity, time on task, and fundamental motor skills at week 0, week 12, and week 24. Physical Activity will be assessed throughout the school year with a wrist-worn wearable accelerometer. Body composition will be assessed with a foot-to-foot bioelectrical impedance scale. Fundamental motor skills will be assessed by the Peabody Developmental Motor Scales 2nd Edition and Time on-task will be measured by observing children in their classroom. The outcomes of this study will be used to implement sustainable physical activity programming for preschoolers.
- Conditions
- Exercise
- Being tested
- Active Play planned movement program
- Keywords
- Preschoolers, Active Play, Teacher guided interventions
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Play planned movement programBehavioural
Teachers will implement an addition two physical activity opportunities that incorporate active play each day for a potential dose of 20-30 minutes per day and 100-150 minutes per week.
| Study group | Role | What they receive |
|---|---|---|
| Active Play Intervention | Experimental | Preschool teachers will be asked to implement two active play activities each preschool day, one indoors and one outdoors. This is in addition to the current outdoor free play of 30 minutes each day. Each activity is 10-15 minutes for a total of 20-30 minutes per day. Receives: Behavioral: Active Play planned movement program |
| Control | No intervention | Preschool teachers will continue to implement their regular curriculum. This consists of one outdoor play opportunity for 30 minutes each day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
An accelerometer attached at the wrist will measure physical activity over 24 hours for 5 days at baseline and 12 weeks
Measured: 12 weeks
Body composition
Percent body fat, ratio of fat mass to lean mass, will be assessed with electrical impedance.
Measured: 12 weeks
Fundamental motor skills
The fundamental motor skill gross quotient will be measured with the Peabody Developmental Motor Scales, Second Edition 2nd edition (PDMS-2). The sum of points comprises the raw scores for each subscale. Raw scores range for each subscale are 6-60 for Stationary Skills, 6-178 for Locomotion Skills, and 6-48 for Object Manipulation Skills. Using age-appropriate tables in the testing manual, we will convert the raw scores to standardized scores (0-20) and summed them to determine the gross motor quartile (GMQ), which has a range of 41 - 164. A higher score indicates a more favorable outcome.
Measured: 12 weeks
Time on Task
The percentage of time spent on task will be observed and presented as a ratio of time on task to time spent off task.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start14 Aug 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two preschools. One will be randomized to the intervention and one to the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle D Wadsworth, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744791
- Sponsor's protocol ID
- 10-217 MR 1009
- Acronym
- Active Play
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Planned Movement and Physical Activity Program on the Physiological and Psychology Parameters in a Pediatric Population
- ClinicalTrials.gov ID
- NCT05744791
- Acronym / sponsor ID
- Active Play / 10-217 MR 1009
- Conditions
- Exercise
- Keywords
- Preschoolers, Active Play, Teacher guided interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 27 Feb 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 randomized clinical trial is to examine the effects of a planned movement in preschool-aged children. The main question is to determine
- What are the effects of a planned movement program on physical activity, body composition, fundamental motor skills, and time on task in preschool children aged 3-5 years?
Researchers will compare a planned movement program to a control group, where current instruction is implemented.
Detailed description
A majority of preschool children do not participate in the recommended levels of physical activity and are deficient in fundamental motor skills. These deficits may also impact body composition. Preschool teachers serve as the gateway to providing physical activity opportunities at preschool but many fail to do so. As play is developmentally appropriate for preschools and part of many curriculums adding active elements to play may be a feasible solution for teachers to implement physical activity opportunities. This project will evaluate the effect of a planned movement program that incorporates elements of active play on preschoolers' body composition, physical activity, time on task, and fundamental motor skills at week 0, week 12, and week 24. Physical Activity will be assessed throughout the school year with a wrist-worn wearable accelerometer. Body composition will be assessed with a foot-to-foot bioelectrical impedance scale. Fundamental motor skills will be assessed by the Peabody Developmental Motor Scales 2nd Edition and Time on-task will be measured by observing children in their classroom. The outcomes of this study will be used to implement sustainable physical activity programming for preschoolers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two preschools. One will be randomized to the intervention and one to the control group.
| Arm | Type | Receives |
|---|---|---|
| Active Play Intervention | Experimental | Behavioral: Active Play planned movement programPreschool teachers will be asked to implement two active play activities each preschool day, one indoors and one outdoors. This is in addition to the current outdoor free play of 30 minutes each day. Each activity is 10-15 minutes for a total of 20-30 minutes per day. |
| Control | No intervention | –Preschool teachers will continue to implement their regular curriculum. This consists of one outdoor play opportunity for 30 minutes each day. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 3 to 5 years of age
- attending one of the preschools 5 days a week.
Key exclusion criteria (3 listed)
- less than 3 years of age
- greater than 5 years of age at the beginning of the study
- attends the preschool 2 days or 3 days a week
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 |
|---|---|---|
| Active Play planned movement programTeachers will implement an addition two physical activity opportunities that incorporate active play each day for a potential dose of 20-30 minutes per day and 100-150 minutes per week. | Behavioural | Active Play Intervention |
Primary outcome
Physical Activity
Time frame: 12 weeks
An accelerometer attached at the wrist will measure physical activity over 24 hours for 5 days at baseline and 12 weeks
Body composition
Time frame: 12 weeks
Percent body fat, ratio of fat mass to lean mass, will be assessed with electrical impedance.
Fundamental motor skills
Time frame: 12 weeks
The fundamental motor skill gross quotient will be measured with the Peabody Developmental Motor Scales, Second Edition 2nd edition (PDMS-2). The sum of points comprises the raw scores for each subscale. Raw scores range for each subscale are 6-60 for Stationary Skills, 6-178 for Locomotion Skills, and 6-48 for Object Manipulation Skills. Using age-appropriate tables in the testing manual, we will convert the raw scores to standardized scores (0-20) and summed them to determine the gross motor quartile (GMQ), which has a range of 41 - 164. A higher score indicates a more favorable outcome.
Time on Task
Time frame: 12 weeks
The percentage of time spent on task will be observed and presented as a ratio of time on task to time spent off task.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Play planned movement program in people with Exercise, run by Auburn University 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?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 6 Mar 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical Activity (time frame: 12 weeks). The study lists 4 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 6 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.