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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02465372
Other study ID # IRB00038003
Secondary ID 1R21HL121692-01A
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date December 31, 2016

Study information

Verified date October 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 599
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CSPAP
Comprehensive School Physical Activity Program.

Locations

Country Name City State
United States Justin B. Moore Columbia South Carolina

Sponsors (3)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Heart, Lung, and Blood Institute (NHLBI), University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Youth Physical Activity Physical activity measured using an accelerometer at baseline and one-year follow-up (spring 2015 and spring 2016). baseline and one-year follow-up
Secondary 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. Up to nine months.
Secondary 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. Up to nine months.
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