Physical ActivityPACTNCT03752008
Preschoolers Active at Child Care (PACT)
A study testing Active Play (AP) and Outdoor Play (OP) in people with Physical Activity, run by Seattle Children's Hospital.
Trial summary
The aim of this study was to develop, test, and compare two approaches to increasing physical activity (PA) and decreasing sedentary time among young children at child care centers, one which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing outdoor free play time (OP=Outdoor Play!). Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Active Play (AP) and Outdoor Play (OP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2012to 24 Apr 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Teachers/Staff
- be a teacher/staff member in a participating childcare center
- Students
- be 3 - 5 years old
- be a full day student in the classroom where data collection was occurring
Who cannot join
- -
About this study
Official title: Preschoolers Active at Child Care
The aim of this study was to develop, test, and compare two approaches to increasing physical activity (PA) and decreasing sedentary time among young children at child care centers, one which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing outdoor free play time (OP=Outdoor Play!).
Read the detailed description
This was a matched pair cluster-randomized study in 10 child care centers. One classroom in each pair received either AP or OP, and their providers received a condition-specific 3-hour workshop. Pre- and post-intervention data were collected from classroom observation and accelerometers. Additional information about teachers' attitudes and practices was collected via pre-intervention survey.
- Conditions
- Physical Activity
- Being tested
- Active Play (AP), Outdoor Play (OP)
- 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 (AP)Behavioural
This intervention focused on promoting PA in preschoolers through structured, teacher-led activities that could be incorporated into daily curriculum. Teachers attended a 3-hour workshop that included presentation and discussion of 1) the importance of daily physical activity for children's health and development, 2) teachers' beliefs and barriers to promoting PA, and 3) the Active Play! Intervention materials. Teachers were introduced to and given the Active Play! Fun Physical Activities for Young Children Book and Digital Video Disk (DVD), which promotes PA and fundamental movement skills in young children. Clips of the DVD demonstrating various activities were shown and activities were modeled. Examples of activities include jumping on bubble wrap, hula hoop limbo and an indoor obstacle course. The end of the book has a suggested curriculum that teachers could follow. Centers in the Active Play! intervention also received a set of portable toys needed for the suggested activities.
Outdoor Play (OP)Behavioural
This intervention focused on promoting outdoor time in preschoolers as a means to increasing their PA, using both child initiated and teacher-led activities. The training and materials were designed to emphasize the teacher's own connection with nature, the benefits of outdoor time for children and adults, and problem solving around barriers encountered. Teachers at participating centers attended one 3-hour workshop (delivered at the childcare center) that focused on having participants recognize their own connection with the natural world and how to transmit that to the next generation. Teachers were given hats and gloves for themselves, a set of rain jackets and boots for the preschoolers, and ideas on what children could do outdoors to be active.
| Study group | Role | What they receive |
|---|---|---|
| Active Play (AP) | Experimental | This arm received the Active Play curriculum intervention (described in following section). Receives: Behavioral: Active Play (AP) |
| Outdoor Play (OP) | Experimental | This arm received the Outdoor Play curriculum intervention (described in following section). Receives: Behavioral: Outdoor Play (OP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre to post change in preschoolers Physical Activity
Physical Activity levels measured by actigraphy monitors
Measured: baseline and 12 weeks after intervention
Pre to post change in Physical Activity Opportunities
Minutes where students could be physically active by observation (RA observed and wrote down times for when children were engaged in various activities and categorized them as active play opportunities or non active play opportunities. Total minutes in each category were calculated.
Measured: baseline and 12 weeks after intervention
Secondary outcomes (1)
pre to post Teacher Physical Activity
Physical Activity levels measured by actigraphy monitors
Measured: baseline and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start4 Dec 2012
- Primary completion24 Apr 2014
- Study completion24 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 10 childcare centers were cluster-randomized to receive either a physical activity or outdoor free play curriculum.
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Pooja Tandon, Seattle Children's Hospital
- Investigators
- Pooja Tandon, MD MPH, Principal investigator, Seattle Chidlren's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752008
- Sponsor's protocol ID
- 14169
- Acronym
- PACT
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preschoolers Active at Child Care
- ClinicalTrials.gov ID
- NCT03752008
- Acronym / sponsor ID
- PACT / 14169
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- 24 Apr 2014 (actual)
- Study completion
- 24 Apr 2014 (actual)
- First posted
- 23 Nov 2018 (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 aim of this study was to develop, test, and compare two approaches to increasing physical activity (PA) and decreasing sedentary time among young children at child care centers, one which focused on a teacher-led PA curriculum (AP=Active Play!) and the other on increasing outdoor free play time (OP=Outdoor Play!).
Detailed description
This was a matched pair cluster-randomized study in 10 child care centers. One classroom in each pair received either AP or OP, and their providers received a condition-specific 3-hour workshop. Pre- and post-intervention data were collected from classroom observation and accelerometers. Additional information about teachers' attitudes and practices was collected via pre-intervention survey.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 childcare centers were cluster-randomized to receive either a physical activity or outdoor free play curriculum.
| Arm | Type | Receives |
|---|---|---|
| Active Play (AP) | Experimental | Behavioral: Active Play (AP)This arm received the Active Play curriculum intervention (described in following section). |
| Outdoor Play (OP) | Experimental | Behavioral: Outdoor Play (OP)This arm received the Outdoor Play curriculum intervention (described in following section). |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Teachers/Staff
- be a teacher/staff member in a participating childcare center
- Students
- be 3 - 5 years old
- be a full day student in the classroom where data collection was occurring
Key exclusion criteria (1 listed)
- -
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 (AP)This intervention focused on promoting PA in preschoolers through structured, teacher-led activities that could be incorporated into daily curriculum. Teachers attended a 3-hour workshop that included presentation and discussion of 1) the importance of daily physical activity for children's health and development, 2) teachers' beliefs and barriers to promoting PA, and 3) the Active Play! Intervention materials. Teachers were introduced to and given the Active Play! Fun Physical Activities for Young Children Book and Digital Video Disk (DVD), which promotes PA and fundamental movement skills in young children. Clips of the DVD demonstrating various activities were shown and activities were modeled. Examples of activities include jumping on bubble wrap, hula hoop limbo and an indoor obstacle course. The end of the book has a suggested curriculum that teachers could follow. Centers in the Active Play! intervention also received a set of portable toys needed for the suggested activities. | Behavioural | Active Play (AP) |
| Outdoor Play (OP)This intervention focused on promoting outdoor time in preschoolers as a means to increasing their PA, using both child initiated and teacher-led activities. The training and materials were designed to emphasize the teacher's own connection with nature, the benefits of outdoor time for children and adults, and problem solving around barriers encountered. Teachers at participating centers attended one 3-hour workshop (delivered at the childcare center) that focused on having participants recognize their own connection with the natural world and how to transmit that to the next generation. Teachers were given hats and gloves for themselves, a set of rain jackets and boots for the preschoolers, and ideas on what children could do outdoors to be active. | Behavioural | Outdoor Play (OP) |
Primary outcome
Pre to post change in preschoolers Physical Activity
Time frame: baseline and 12 weeks after intervention
Physical Activity levels measured by actigraphy monitors
Pre to post change in Physical Activity Opportunities
Time frame: baseline and 12 weeks after intervention
Minutes where students could be physically active by observation (RA observed and wrote down times for when children were engaged in various activities and categorized them as active play opportunities or non active play opportunities. Total minutes in each category were calculated.
1 secondary outcome
pre to post Teacher Physical Activity
Time frame: baseline and 12 weeks after intervention
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 26 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Pooja Tandon, MD MPH principal investigator
Seattle Chidlren's
Questions about this trial
What is this clinical trial studying?
A study testing Active Play (AP) and Outdoor Play (OP) in people with Physical Activity, run by Seattle Children's Hospital.
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 5 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 26 Nov 2018. 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?
Pre to post change in preschoolers Physical Activity (time frame: baseline and 12 weeks after intervention). The study lists 2 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 Nov 2018.