- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692702
Wellness Enhancing Physical Activity for Young Children
October 1, 2018 updated by: Jessica Hoffman, Northeastern University
Wellness Enhancing Physical Activity for Young Children Preschool Teacher Training
Wellness Enhancing Physical Activity for Young Children (WE PLAY) is a teacher training that is based online and was designed to support early childhood educators' efforts to promote physical activity (PA) through structured and unstructured active play with preschoolers.
WE PLAY includes six components: (1) online training; (2) video library; (3) game sheets; (4) teacher self-assessment; (5) supervisor support; and (6) activity packs that are designed to work synergistically.
The purpose of this study was to examine the impact of WE PLAY on children's levels of moderate to vigorous physical activity (MVPA) during school hours.
We hypothesized that children whose teachers received WE PLAY would have higher levels of MVPA during school hours at post-intervention relative to pre-intervention and relative to children whose teachers did not receive WE PLAY.
A second purpose was to examine the impact of WE PLAY on teacher outcomes (i.e., knowledge, intentions, perceived behavior control, subjective norms, perceived power beliefs, normative beliefs, and moral norms).
We hypothesized that teachers who participated in WE PLAY would demonstrate higher scores on each of these variables at post-intervention relative to pre-intervention and to teachers in the control group.
A cluster randomized controlled trial was used in this study.
Six Head Start preschools were pair matched and randomized to the intervention (WE PLAY) or control groups.
Preschool children (N=57) and their teachers (N=25) participated.
Child MVPA was measured using accelerometers for 5-day periods at pre- and post-intervention.
Teacher variables were measured using online surveys.
Study Overview
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Northeastern University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All teachers at the participating programs, and all children within the participating teachers' classrooms, were eligible to participate in this study.
Exclusion Criteria:
- There were no exclusion criteria based on gender, race/ethnicity, language spoken at home, socio-economic level, or any other demographic variable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: WE PLAY
Teachers in this condition received the WE PLAY training.
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WE PLAY is an online preschool teacher training that is based in theory and implementation science.
It contains six components: (1) online training; (2) video library; (3) game sheets; (4) teacher self-assessment; (5) supervisor support; and (6) activity packs containing low cost physical activity equipment
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No Intervention: Control
Preschools in this condition received the same physical activity equipment that preschools in the WE PLAY condition received.
Teachers were not provided with any specific instructions or information about physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Moderate to Vigorous Physical Activity (MVPA) per minute in children
Time Frame: Pre-intervention was in week 1 and post-intervention was in week 4
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We measured child PA using ActiGraph GT9X Link monitors for 24-hour periods across five days at both pre-intervention and post-intervention
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Pre-intervention was in week 1 and post-intervention was in week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in teacher knowledge
Time Frame: Pre-intervention (week 1; both groups). The WE PLAY group's knowledge was assessed again immediately following the online training (week 2). The control group's knowledge was measured a second time at the post-intervention assessment (week 4).
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12 knowledge items were developed for this study and were drawn from content covered in the online training.
Scores ranged from 0-12.
Higher scores indicate higher levels of knowledge.
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Pre-intervention (week 1; both groups). The WE PLAY group's knowledge was assessed again immediately following the online training (week 2). The control group's knowledge was measured a second time at the post-intervention assessment (week 4).
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Change in perceived behavioral control
Time Frame: Pre-intervention (week 1) and post-intervention (week 4)
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Items (n=4) were from a previously developed scale.
Scores ranged from 4-24.
Higher scores indicate more positive perceptions about one's ability to promote physical activity with students.
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Pre-intervention (week 1) and post-intervention (week 4)
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Change in subjective norms
Time Frame: Pre-intervention (week 1) and post-intervention (week 4)
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Items (n=3) were from a previously developed scale.
Scores ranged from 3-18.
Higher scores indicate that promoting physical activity with children is viewed as important by the people most important to the respondent.
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Pre-intervention (week 1) and post-intervention (week 4)
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Change in moral norms
Time Frame: Pre-intervention (week 1) and post-intervention (week 4)
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Items (n=4) were from a previously developed scale.
Scores ranged from 4-24.
Higher scores indicate a stronger moral obligation to promote physical activity with students.
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Pre-intervention (week 1) and post-intervention (week 4)
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Change in normative beliefs
Time Frame: Pre-intervention (week 1) and post-intervention (week 4)
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Items (n=5) were from a previously developed scale.
Scores ranged from 5-30.
Higher scores indicate that important people surrounding the respondent think that promoting physical activity with students is important.
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Pre-intervention (week 1) and post-intervention (week 4)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jessica A Hoffman, PhD, Northeastern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2017
Primary Completion (Actual)
May 4, 2018
Study Completion (Actual)
July 18, 2018
Study Registration Dates
First Submitted
September 28, 2018
First Submitted That Met QC Criteria
September 28, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
October 3, 2018
Last Update Submitted That Met QC Criteria
October 1, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- WEPLAY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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