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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Northeastern University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WE PLAY
Teachers in this condition received the WE PLAY training.
Behavioral: WE PLAY
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre-intervention was in week 1 and post-intervention was in week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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.
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)
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.
Pre-intervention (week 1) and post-intervention (week 4)
Change in subjective norms
Time Frame: Pre-intervention (week 1) and post-intervention (week 4)
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.
Pre-intervention (week 1) and post-intervention (week 4)
Change in moral norms
Time Frame: Pre-intervention (week 1) and post-intervention (week 4)
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.
Pre-intervention (week 1) and post-intervention (week 4)
Change in normative beliefs
Time Frame: Pre-intervention (week 1) and post-intervention (week 4)
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.
Pre-intervention (week 1) and post-intervention (week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northeastern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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