Physical ActivitySHAPESNCT01885325
Multi-component Intervention to Increase Physical Activity in Preschool Children
A study testing Physical Activity Preschool Intervention in people with Physical Activity, run by University of South Carolina.
Trial summary
The study addresses a critical public health problem, childhood obesity, by testing a physical activity intervention in the types of preschools that millions of children attend. Information gained in this study may lead to adoption of preschool policies and instructional practices that increase physical activity and… 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?
- Physical Activity Preschool Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jun 2012
- 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
- All children from participating K-4 classrooms at the participating schools were invited to participate.
Who cannot join
- Children were excluded only if they had a condition that would limit data collection using an accelerometer (e.g., non-ambulatory children)
About this study
The study addresses a critical public health problem, childhood obesity, by testing a physical activity intervention in the types of preschools that millions of children attend. Information gained in this study may lead to adoption of preschool policies and instructional practices that increase physical activity and reduce the risk of obesity in preschool children.
Read the detailed description
Obesity rates in 3-5 year-old American children have increased dramatically in recent decades. Concurrent with this alarming trend, time spent by young children in preschool settings has increased and their time spent in unstructured play has decreased. Recent studies have shown that children in preschools are engaged primarily in sedentary activities. Nonetheless, few interventions designed to increase PA or decrease sedentary behavior have been evaluated in preschool children. The proposed investigation tested a multicomponent intervention designed to increase physical activity energy expenditure (PAEE) in 3-5 year-old children. Sixteen preschools were randomly assigned to intervention or control groups. 500 children, in two annual waves of ~250 children, participated in the measurement protocol at baseline and after exposure to the intervention for 9 months. Child-level measures included moderate-to-vigorous PA, sedentary behavior, and PAEE measured by accelerometry; height, weight and waist circumference; and demographics. The intervention consisted of four components: Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (PA in classroom, academic lessons), and enhancing the social environment to promote PA. The study's intervention coordinator worked with the preschool directors, teachers, and assistant teachers to facilitate intervention implementation by providing training, materials, and ongoing support and feedback. An extensive process evaluation documented the extent to which the intervention was implemented. Effects of the intervention on PA, sedentary behavior, PAEE, and weight status were determined. In addition, the study examined factors that associate with change in physical activity, sedentary behavior, physical activity energy expenditure and body mass index during a school year in preschool children.
- Conditions
- Physical Activity
- Being tested
- Physical Activity Preschool Intervention
- Keywords
- Physical Activity, Sedentary Behavior, Preschool Children
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Preschool InterventionOther
Preschools randomized to the multi-component physical activity preschool intervention received four major components:Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical activity in classroom, academic lessons), and enhancing the social environment to promote PA.The focus in the physical education classes, recess, daily lessons, and reduction of sedentary time will be on providing activities that 3-to 5-year-old children enjoy.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Preschool Intervention | Experimental | Preschools randomized to the multi-component physical activity preschool intervention received four major components: Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical Activity in classroom, academic lessons), and enhancing the social environment to promote Physical Activity. Receives: Other: Physical Activity Preschool Intervention |
| Control | No intervention | The preschools in the control group did not receive the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA)
MVPA was assessed using an accelerometer. Participants wore the accelerometer during all waking hours for 5 consecutive weekdays. MVPA was determined by applying count cutpoints to the accelerometer data and calculating minutes spent above the MVPA threshold (minutes per hour).
Measured: Measured at baseline and 10 months for each wave of data collection
Secondary outcomes (3)
Change in Minutes of Sedentary Behavior
Sedentary behavior was assessed using an accelerometer. Participants wore the accelerometer during all waking hours for 5 consecutive weekdays. Time spent in sedentary behavior was determined by applying count cutpoints to the accelerometer data and calculating minutes spent below the light activity threshold (minutes per hour).
Measured: Measured at baseline and 10 months for each wave of data collection
Change in Physical Activity Energy Expenditure (PAEE)
PAEE is an expression of the energy expended during physical activity. PAEE was assessed via objective measures of physical activity with accelerometry. Participants wore an accelerometer during all waking hours for 5 consecutive weekdays. PAEE was determined by applying criteria to the accelerometer output and weighting the minutes of activity by MET values appropriate for moderate (4 METs) and vigorous activity (7 METs) in this age group.
Measured: Measured at baseline and 10 months for each wave of data collection
Change in Body Mass Index (BMI)
BMI was calculated from measured height and weight for each child and is reported as kg/m^2. Assessments were made using standard anthropometric procedures.
Measured: Measured at baseline and 10 months for each wave of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startAug 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Russell Pate, University of South Carolina
- Investigators
- Russell R Pate, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885325
- Sponsor's protocol ID
- Pro00004884
- Other IDs
- 1R01HD055451
- Acronym
- SHAPES
- Status last verified
- Apr 2019
- First submitted
- 20 May 2013
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pate RR, Brown WH, Pfeiffer KA, Howie EK, Saunders RP, Addy CL, Dowda M. An Intervention to Increase Physical Activity in Children: A Randomized Controlled Trial With 4-Year-Olds in Preschools. Am J Prev Med. 2016 Jul;51(1):12-22. doi: 10.1016/j.amepre.2015.12.003. Epub 2016 Jan 20.
PubMed 26803357Pfeiffer KA, Saunders RP, Brown WH, Dowda M, Addy CL, Pate RR. Study of Health and Activity in Preschool Environments (SHAPES): study protocol for a randomized trial evaluating a multi-component physical activity intervention in preschool children. BMC Public Health. 2013 Aug 7;13:728. doi: 10.1186/1471-2458-13-728.
PubMed 23919808
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-component Intervention to Increase Physical Activity in Preschool Children
- ClinicalTrials.gov ID
- NCT01885325
- Acronym / sponsor ID
- SHAPES / Pro00004884
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Sedentary Behavior, Preschool Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Jun 2013 (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 study addresses a critical public health problem, childhood obesity, by testing a physical activity intervention in the types of preschools that millions of children attend. Information gained in this study may lead to adoption of preschool policies and instructional practices that increase physical activity and reduce the risk of obesity in preschool children.
Detailed description
Obesity rates in 3-5 year-old American children have increased dramatically in recent decades. Concurrent with this alarming trend, time spent by young children in preschool settings has increased and their time spent in unstructured play has decreased. Recent studies have shown that children in preschools are engaged primarily in sedentary activities. Nonetheless, few interventions designed to increase PA or decrease sedentary behavior have been evaluated in preschool children. The proposed investigation tested a multicomponent intervention designed to increase physical activity energy expenditure (PAEE) in 3-5 year-old children. Sixteen preschools were randomly assigned to intervention or control groups. 500 children, in two annual waves of ~250 children, participated in the measurement protocol at baseline and after exposure to the intervention for 9 months. Child-level measures included moderate-to-vigorous PA, sedentary behavior, and PAEE measured by accelerometry; height, weight and waist circumference; and demographics. The intervention consisted of four components: Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (PA in classroom, academic lessons), and enhancing the social environment to promote PA. The study's intervention coordinator worked with the preschool directors, teachers, and assistant teachers to facilitate intervention implementation by providing training, materials, and ongoing support and feedback. An extensive process evaluation documented the extent to which the intervention was implemented. Effects of the intervention on PA, sedentary behavior, PAEE, and weight status were determined. In addition, the study examined factors that associate with change in physical activity, sedentary behavior, physical activity energy expenditure and body mass index during a school year in preschool children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Preschool Intervention | Experimental | Other: Physical Activity Preschool InterventionPreschools randomized to the multi-component physical activity preschool intervention received four major components: Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical Activity in classroom, academic lessons), and enhancing the social environment to promote Physical Activity. |
| Control | No intervention | –The preschools in the control group did not receive the intervention |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children from participating K-4 classrooms at the participating schools were invited to participate.
Key exclusion criteria (1 listed)
- Children were excluded only if they had a condition that would limit data collection using an accelerometer (e.g., non-ambulatory children)
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 |
|---|---|---|
| Physical Activity Preschool InterventionPreschools randomized to the multi-component physical activity preschool intervention received four major components:Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical activity in classroom, academic lessons), and enhancing the social environment to promote PA.The focus in the physical education classes, recess, daily lessons, and reduction of sedentary time will be on providing activities that 3-to 5-year-old children enjoy. | Other | Physical Activity Preschool Intervention |
Primary outcome
Change in Minutes of Moderate-to- Vigorous Physical Activity (MVPA)
Time frame: Measured at baseline and 10 months for each wave of data collection
MVPA was assessed using an accelerometer. Participants wore the accelerometer during all waking hours for 5 consecutive weekdays. MVPA was determined by applying count cutpoints to the accelerometer data and calculating minutes spent above the MVPA threshold (minutes per hour).
3 secondary outcomes
Change in Minutes of Sedentary Behavior
Time frame: Measured at baseline and 10 months for each wave of data collection
Change in Physical Activity Energy Expenditure (PAEE)
Time frame: Measured at baseline and 10 months for each wave of data collection
Change in Body Mass Index (BMI)
Time frame: Measured at baseline and 10 months for each wave of data collection
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 18 Apr 2019.
- Derived from this study: PubMed 26803357Pate RR, Brown WH, Pfeiffer KA, Howie EK, Saunders RP, Addy CL, Dowda M. An Intervention to Increase Physical Activity in Children: A Randomized Controlled Trial With 4-Year-Olds in Preschools. Am J Prev Med. 2016 Jul;51(1):12-22. doi: 10.1016/j.amepre.2015.12.003. Epub 2016 Jan 20.
- Derived from this study: PubMed 23919808Pfeiffer KA, Saunders RP, Brown WH, Dowda M, Addy CL, Pate RR. Study of Health and Activity in Preschool Environments (SHAPES): study protocol for a randomized trial evaluating a multi-component physical activity intervention in preschool children. BMC Public Health. 2013 Aug 7;13:728. doi: 10.1186/1471-2458-13-728.
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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.
Russell R Pate, PhD principal investigator
University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Preschool Intervention in people with Physical Activity, run by University of South Carolina.
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 1 inclusion and 1 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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 in Minutes of Moderate-to- Vigorous Physical Activity (MVPA) (time frame: Measured at baseline and 10 months for each wave of data collection). 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 NCT01885325, which also lists 2 linked publications.
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 18 Apr 2019; AzTrials last refreshed its copy on 4 Nov 2026.