- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02465372
Be a Champion! Comprehensive School Physical Activity Program (BAC!)
October 18, 2018 updated by: Wake Forest University Health Sciences
Utilizing Physical Activity Coordinators to Increase Physical Activity Among Youth
The purpose of this project is to develop a Comprehensive School Physical Activity Program (CSPAP) training protocol, and test the feasibility, acceptability, and effectiveness of its delivery in an elementary school setting.
Study Overview
Detailed Description
Children across the United States are insufficiently physically active.
In response, numerous physical activity (PA) interventions have been developed and tested, the majority within the school setting.
Unfortunately, these have resulted in limited, if any impact on children's PA.
The investigators feel that this absence of effect stems from a lack of tailoring at the school level and a resulting lack in institutionalization.
To address the latter issue, the investigators feel that it is important to leverage existing resources and capitalize on existing policies.
The state of South Carolina has instituted the role of "Physical Activity Coordinators" to promote PA among students across and beyond the school day.
However, while these positions are mandated by state law, the individuals in these positions often lack the training and support to maximize their impact.
Our long-term goal is to develop best practices to inform the national movement to train school PA Coordinators to deliver a Comprehensive School Physical Activity Program (CSPAP) within schools that can be disseminated across the country.
The objectives of the current application are to: 1) modify and expand existing CSPAP training curricula for PA Coordinators; 2) deliver the enhanced PA Coordinator training in our pilot schools; 3) conduct process evaluation on the implementation of a CSPAP by the PA Coordinators, and 4) evaluate the effectiveness of the trainings to increase children's objectively measured PA.
The goal of the proposed study is to determine the acceptability, feasibility, and effectiveness of properly train PA Coordinators to promote PA in elementary school children.
This goal will be achieved through the following aims: AIM 1: Develop an enhanced CSPAP training course and resource toolkit for PA Coordinators.
AIM 2: Determine the acceptability/feasibility of the enhanced PA coordinator training and the implementation of a Comprehensive School Physical Activity Program in an elementary school setting.
AIM 3: Determine the effectiveness of trained PA coordinators to increase objectively measured PA in elementary school youth.
the investigators will randomize four schools to receive the PA Coordinator training (n=2) or continue standard practice (n=2).
A comprehensive process and impact evaluation will be conducted to determine acceptability of the intervention, factors influencing implementation fidelity/dose, and the effectiveness of the PA Coordinators to increase physical activity measured via accelerometry in children.
Study Type
Interventional
Enrollment (Actual)
599
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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South Carolina
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Columbia, South Carolina, United States, 29208
- Justin B. Moore
-
-
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
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrolled in grades 2 - 5 at the participating school sites.
Exclusion Criteria:
- Physical or mental impairment that would preclude physical activity or protocol compliance.
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 |
---|---|
Experimental: CSPAP
Schools in this arm will receive the Comprehensive School Physical Activity Program training.
|
Comprehensive School Physical Activity Program.
Other Names:
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No Intervention: Control
Standard practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Youth Physical Activity
Time Frame: baseline and one-year follow-up
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Physical activity measured using an accelerometer at baseline and one-year follow-up (spring 2015 and spring 2016).
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baseline and one-year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the Be a Champion! Program
Time Frame: Up to nine months.
|
Implementation monitoring to determine feasibility of the program as indicated by the percentage of planned tasks achieved with full fidelity and as determined by the number who, a) assembled an implementation team, b) completed all trainings, c) completed self-assessments, d) developed action plans, and e) executed at least one component of their action plans.
|
Up to nine months.
|
Acceptability of the Be a Champion! Program
Time Frame: Up to nine months.
|
Number of schools that indicated BAC was acceptable, based upon qualitative and quantitative feedback from principals, classroom teachers, and implementation teams.
|
Up to nine months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Justin Moore, Ph.D., Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
August 1, 2014
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
May 21, 2015
First Submitted That Met QC Criteria
June 4, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
November 14, 2018
Last Update Submitted That Met QC Criteria
October 18, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00038003
- 1R21HL121692-01A1 (U.S. NIH Grant/Contract)
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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