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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| CSPAP | Experimental | Schools in this arm will receive the Comprehensive School Physical Activity Program training. Receives: Behavioral: CSPAP |
| Control | No intervention | Standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
- First posted8 Jun 2015 (estimated)
- Study startAug 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor 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
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Justin Moore, Ph.D., Principal investigator, Wake Forest University Health Sciences
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Physical Activity Coordinators to Increase Physical Activity Among Youth
- ClinicalTrials.gov ID
- NCT02465372
- Acronym / sponsor ID
- BAC! / IRB00038003
- Conditions
- Motor Activity
- Keywords
- Physical Activity, Youth, School Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of South Carolina, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSPAP | Experimental | Behavioral: CSPAPSchools in this arm will receive the Comprehensive School Physical Activity Program training. |
| Control | No intervention | –Standard practice. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled in grades 2 - 5 at the participating school sites.
Key exclusion criteria (1 listed)
- Physical or mental impairment that would preclude physical activity or protocol compliance.
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 |
|---|---|---|
| CSPAPAlso: Be a Champion!Comprehensive School Physical Activity Program. | Behavioural | CSPAP |
Primary outcome
Change in Youth Physical Activity
Time frame: baseline and one-year follow-up
Physical activity measured using an accelerometer at baseline and one-year follow-up (spring 2015 and spring 2016).
2 secondary outcomes
Feasibility of the Be a Champion! Program
Time frame: Up to nine months.
Acceptability of the Be a Champion! Program
Time frame: Up to nine months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31102834Singletary 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.
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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.
Justin Moore, Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
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.