Physical ActivitySTEPNCT01588392
Short bouTs of Exercise for Preschool-age Children
A study testing Short bouts of structured physical activity and Unstructured physical activity in people with Physical Activity, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The purpose of this study is to examine if short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime will increase preschool-age children during-school physical activity level. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Short bouts of structured physical activity and Unstructured physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Sep 2013
- 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
- Attend one of 10 participating preschool centers
- Attend preschool full-time
- Children between 2.9 - 5 years of age on the date of baseline assessment
Who cannot join
- Did not have a condition limiting their participation in routine gross-motor playtime at preschool
- Unable to wear the activity monitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Preschool centers in Springfield, MA
Springfield, Massachusetts, 01103
About this study
Official title: Effects of Short Bouts of Physical Activity in Low-income Preschool-age Children
The purpose of this study is to examine if short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime will increase preschool-age children during-school physical activity level.
Read the detailed description
Most preschool centers provide two 30-minute sessions of gross-motor/outdoor playtime per preschool day. Within this time frame, children accumulate most of their activity within the first 10 minutes. This study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity in preschoolers. Results from this intervention could provide evidence that a physical activity policy that exposes preschoolers to shorter bouts of structured physical activity throughout the preschool day could potentially increase preschooler's physical activity levels.
- Conditions
- Physical Activity
- Being tested
- Short bouts of structured physical activity, Unstructured physical activity
- Keywords
- Physical activity, preschoolers
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short bouts of structured physical activityBehavioural
Also called Instant Recess for preschoolers
Short bouts of structured physical activity preschools will be asked to implement age-appropriate 10 minute structured physical activity routines within the classroom setting followed by 20 minutes of usual unstructured playtime activities. Intervention will be implemented for a total of 30 minutes during both morning and afternoon gross motor playtime 5 days/week for 6 months.
Unstructured physical activityBehavioural
Also called Free playtime
Unstructured physical activity intervention will consist of 30 minutes of supervised unstructured free playtime twice. intervention will be delivered during both morning and afternoon gross motor playtime for 5 days/week for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Short bouts of structured activity | Experimental | Not described Receives: Behavioral: Short bouts of structured physical activity |
| Unstructured physical activity | Active comparator | Not described Receives: Behavioral: Unstructured physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Physical activity levels at 6-month
Physical activity levels will be assessed with accelerometer and direct observation system
Measured: Baseline, 3-month and 6-month after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Masking
- None (open label)
- Enrolment
- 323 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, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588392
- Sponsor's protocol ID
- 2010-0817
- Acronym
- STEP
- Status last verified
- Jun 2023
- First submitted
- 25 Apr 2012
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Alhassan S, Nwaokelemeh O, Mendoza A, Shitole S, Whitt-Glover MC, Yancey AK. Design and baseline characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study. BMC Public Health. 2012 Aug 1;12:582. doi: 10.1186/1471-2458-12-582.
PubMed 22853642
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short Bouts of Physical Activity in Low-income Preschool-age Children
- ClinicalTrials.gov ID
- NCT01588392
- Acronym / sponsor ID
- STEP / 2010-0817
- Conditions
- Physical Activity
- Keywords
- Physical activity, preschoolers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 May 2012 (estimated)
- 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 purpose of this study is to examine if short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime will increase preschool-age children during-school physical activity level.
Detailed description
Most preschool centers provide two 30-minute sessions of gross-motor/outdoor playtime per preschool day. Within this time frame, children accumulate most of their activity within the first 10 minutes. This study is a cluster randomized controlled study designed to examine the effects of short bouts of structured physical activity implemented within the classroom setting as part of designated gross-motor playtime on during-school physical activity in preschoolers. Results from this intervention could provide evidence that a physical activity policy that exposes preschoolers to shorter bouts of structured physical activity throughout the preschool day could potentially increase preschooler's physical activity levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short bouts of structured activity | Experimental | Behavioral: Short bouts of structured physical activity |
| Unstructured physical activity | Active comparator | Behavioral: Unstructured physical activity |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Attend one of 10 participating preschool centers
- Attend preschool full-time
- Children between 2.9 - 5 years of age on the date of baseline assessment
Key exclusion criteria (2 listed)
- Did not have a condition limiting their participation in routine gross-motor playtime at preschool
- Unable to wear the activity monitor
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 |
|---|---|---|
| Short bouts of structured physical activityAlso: Instant Recess for preschoolersShort bouts of structured physical activity preschools will be asked to implement age-appropriate 10 minute structured physical activity routines within the classroom setting followed by 20 minutes of usual unstructured playtime activities. Intervention will be implemented for a total of 30 minutes during both morning and afternoon gross motor playtime 5 days/week for 6 months. | Behavioural | Short bouts of structured activity |
| Unstructured physical activityAlso: Free playtimeUnstructured physical activity intervention will consist of 30 minutes of supervised unstructured free playtime twice. intervention will be delivered during both morning and afternoon gross motor playtime for 5 days/week for 6 months. | Behavioural | Unstructured physical activity |
Primary outcome
Change from baseline in Physical activity levels at 6-month
Time frame: Baseline, 3-month and 6-month after study initiation
Physical activity levels will be assessed with accelerometer and direct observation system
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 8 Jun 2023.
- Derived from this study: PubMed 22853642Alhassan S, Nwaokelemeh O, Mendoza A, Shitole S, Whitt-Glover MC, Yancey AK. Design and baseline characteristics of the Short bouTs of Exercise for Preschoolers (STEP) study. BMC Public Health. 2012 Aug 1;12:582. doi: 10.1186/1471-2458-12-582.
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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 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 Short bouts of structured physical activity and Unstructured physical activity in people with Physical Activity, 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?
The sponsor lists 3 inclusion and 2 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 8 Jun 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?
Change from baseline in Physical activity levels at 6-month (time frame: Baseline, 3-month and 6-month after study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01588392, which also lists 1 linked publication.
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 8 Jun 2023.