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Motor ActivityBAC!NCT02465372

Be a Champion! Comprehensive School Physical Activity Program

A study testing CSPAP in people with Motor Activity, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Motor Activity
What is being tested?
CSPAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
599 participants
Where
1 siteUnited States
Study dates
Aug 2014to 31 Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Enrolled in grades 2 - 5 at the participating school sites.

Who cannot join

  • Physical or mental impairment that would preclude physical activity or protocol compliance.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Justin B. Moore

    Columbia, South Carolina, 29208

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Motor Activity
Being tested
CSPAP
Keywords
Physical Activity, Youth, School Health
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSPAPBehavioural

    Also called Be a Champion!

    Comprehensive School Physical Activity Program.

Study groups in NCT02465372
Study groupRoleWhat they receive
CSPAPExperimentalSchools in this arm will receive the Comprehensive School Physical Activity Program training.
Receives: Behavioral: CSPAP
ControlNo interventionStandard practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Youth Physical Activity

    Physical activity measured using an accelerometer at baseline and one-year follow-up (spring 2015 and spring 2016).

    Measured: baseline and one-year follow-up

Secondary outcomes (2)
  1. Feasibility of the Be a Champion! Program

    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.

    Measured: Up to nine months.

  2. Acceptability of the Be a Champion! Program

    Number of schools that indicated BAC was acceptable, based upon qualitative and quantitative feedback from principals, classroom teachers, and implementation teams.

    Measured: Up to nine months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study startAug 2014
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2016

Resources

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
599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465372
Sponsor's protocol ID
IRB00038003
Other IDs
1R21HL121692-01A1
Acronym
BAC!
Status last verified
Oct 2018
First submitted
21 May 2015
Last updated
14 Nov 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Singletary CR, Weaver G, Carson RL, Beets MW, Pate RR, Saunders RP, Peluso AG, Moore JB. Evaluation of a comprehensive school physical activity program: Be a Champion! Eval Program Plann. 2019 Aug;75:54-60. doi: 10.1016/j.evalprogplan.2019.04.003. Epub 2019 May 2.

    PubMed 31102834

Questions about this trial

What is this clinical trial studying?

A study testing CSPAP in people with Motor Activity, run by Wake Forest University Health Sciences 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 14 Nov 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?

Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Youth Physical Activity (time frame: baseline and one-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02465372, which also lists 1 linked publication.

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 14 Nov 2018.

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