Physical ActivityNCT03692702
Wellness Enhancing Physical Activity for Young Children
A study testing WE PLAY in people with Physical Activity, run by Northeastern University at 1 site in United States.
Trial summary
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. 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?
- WE PLAY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 18 Jul 2018
- 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 teachers at the participating programs, and all children within the participating teachers' classrooms, were eligible to participate in this study.
Who cannot join
- There were no exclusion criteria based on gender, race/ethnicity, language spoken at home, socio-economic level, or any other demographic variable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Physical Activity
- Being tested
- WE PLAY
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WE PLAYBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| WE PLAY | Experimental | Teachers in this condition received the WE PLAY training. Receives: Behavioral: WE PLAY |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Moderate to Vigorous Physical Activity (MVPA) per minute in children
We measured child PA using ActiGraph GT9X Link monitors for 24-hour periods across five days at both pre-intervention and post-intervention
Measured: Pre-intervention was in week 1 and post-intervention was in week 4
Secondary outcomes (5)
Change in teacher knowledge
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.
Measured: 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).
Change in perceived behavioral control
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.
Measured: Pre-intervention (week 1) and post-intervention (week 4)
Change in subjective norms
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.
Measured: Pre-intervention (week 1) and post-intervention (week 4)
Change in moral norms
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.
Measured: Pre-intervention (week 1) and post-intervention (week 4)
Change in normative beliefs
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.
Measured: Pre-intervention (week 1) and post-intervention (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start30 Oct 2017
- Primary completion4 May 2018
- Study completion18 Jul 2018
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.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Hoffman, Northeastern University
- Investigators
- Jessica A Hoffman, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692702
- Sponsor's protocol ID
- WEPLAY
- Status last verified
- Oct 2018
- First submitted
- 28 Sep 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness Enhancing Physical Activity for Young Children Preschool Teacher Training
- ClinicalTrials.gov ID
- NCT03692702
- Acronym / sponsor ID
- WEPLAY
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 2 Oct 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WE PLAY | Experimental | Behavioral: WE PLAYTeachers in this condition received the WE PLAY training. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All teachers at the participating programs, and all children within the participating teachers' classrooms, were eligible to participate in this study.
Key exclusion criteria (1 listed)
- There were no exclusion criteria based on gender, race/ethnicity, language spoken at home, socio-economic level, or any other demographic variable.
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 |
|---|---|---|
| WE PLAYWE 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 | Behavioural | WE PLAY |
Primary outcome
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
We measured child PA using ActiGraph GT9X Link monitors for 24-hour periods across five days at both pre-intervention and post-intervention
5 secondary outcomes
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).
Change in perceived behavioral control
Time frame: Pre-intervention (week 1) and post-intervention (week 4)
Change in subjective norms
Time frame: Pre-intervention (week 1) and post-intervention (week 4)
Change in moral norms
Time frame: Pre-intervention (week 1) and post-intervention (week 4)
Change in normative beliefs
Time frame: Pre-intervention (week 1) and post-intervention (week 4)
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 3 Oct 2018.
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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.
Jessica A Hoffman, PhD principal investigator
Northeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WE PLAY in people with Physical Activity, run by Northeastern 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 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 3 Oct 2018. 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 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). 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 3 Oct 2018.