- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03847831
Feasibility Study of the Pilot Post-primary Active School Flag (PPASF) Program (PPASF)
Postprimary Active School Flag Feasibility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a feasibility study of the post-primary Active School Flag (PPASF) programme. Schools in Ireland that meet the eligibility criteria of; 1) second level education school, 2) has not already achieved the Active School Flag, 3) volunteered to be in the study were selected to take part in this pilot study. Schools not in the programme were matched to provide a comparison data set.
Schools involved in the study are given resources to support the year long program so the school may achieve the PPASF certificate. To achieve the certificate, the schools needed to complete 17 tasks throughout the school year; 1) a staff slideshow, 2) an PPASF team slideshow, 3) class time slideshow 4) PPASF training day, 5) an PPASF awareness week (towards the beginning of the year), 6) website showcase, 7) PPASF whole school questionnaire, 8) PPASF launch event, 9) PPASF action plan, 10) 'Did You Know?' campaign, 11) PA module as part of Social, personal and health education (SPHE) subject for junior cycle students, 12) Active School WALKWAY, 13) Community Mapping of extra curriculum activities, 14) Community Event, 5) Active School Week, 16) PPASF accreditation visit, and 17) school PA space audits.
The PPASF is part of the developing Healthy Ireland Demonstration Project, and the feasibility to collect data in the form of accelerometers, physical health measures and self-perceptions of health are also included in the feasilibility study.
The feasibility study will be monitored quantitatively through a custom design fidelity check list, and in depth process evaluation that includes qualitative methods such as one to one interviews and focus group interviews throughout the academic year.
The secondary outcomes are based on the hypotheses that 1) intervention schools will have more physical activity opportunities and thus 2) more physically active students, especially during the school day. Furthermore, there would be 3) a decrease in sitting time, 4) positive associations between academic related behaviours with physical activity behaviours, 5) and no increase in BMI.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Limerick, Ireland
- University of Limerick
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- students and teachers in the enrolled schools
Exclusion Criteria:
- students and teachers not enrolled in the schools
- students who did not provide consent or assent to take part in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PPASF Group
Schools enrolled in the postprimary active school flag program. All 17 elements are included. Feasibility is measured of the 17 elements. Student representatives are selected to have accelerometer, physical health measures and perceived health collected for feasibility purposes. |
Schools enrolled in the program take part in the 17 actions described in the PPASF.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the PPASF programme's components in the schools
Time Frame: up to 9 months
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Customized fidelity check list based on the 17 program elements.
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up to 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants in designated areas of school assessed through a modified version of the SOPLAY protocol
Time Frame: up to 9 months
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A modified version of the "System for Observing Play and Leisure Active In Youth (SOPLAY)" protocol in pre-specified designed areas of the school grounds.
The protocol is carried out once a month, carried out by trained students in the school, with assistance of teachers and researchers.
Trained students scan the designed area of the school ground from left to right and tally the number of people they encounter that are sedentary, walking or very active.
Additional information is collected about the accessibility of the area, the suitability for physical activity, whether there is staff supervision in the area, if the activities are organized physical activity, and if there is any equipment.
The count data is marked for each observation period and monitored over time.
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up to 9 months
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Changes in physical activity opportunities through questionnaires
Time Frame: up to 9 months
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Survey items to state the opportunities in school lessons, recess and after-school activities.
A check box of sport and physical activities is counted and compared between time points.
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up to 9 months
|
Changes in physical activity levels by accelerometer
Time Frame: up to 9 months
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Accelerometers placed on the thigh for a minimum of 4 days (1 weekend day) and at least 10h of wear time per day
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up to 9 months
|
Changes in physical activity levels by self-reported physical activity through questionnaires
Time Frame: up to 9 months
|
Self-report PA by questionnaire.
Two short measures (Prochaska et al, 2001).
Both response scales are from 0-7days.
Q1 based on the past 7 days.
Q2 is based on the average week.
Results are averaged and rounded up.
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up to 9 months
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Changes in (accelerometer based) sedentary time during the school day
Time Frame: up to 9 months
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Accelerometers placed on the thigh to measure inclination and algorithm to detect sitting and lying time.
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up to 9 months
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Changes to self-reported academic performance
Time Frame: up to 9 months
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Self-report surveys of perceived academic performance.
A four point scale of 'below average' 'average' 'good', 'excellent'.
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up to 9 months
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Changes to self-reported academic performance behaviours
Time Frame: up to 9 months
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Self-report surveys of Harter's self-perception scale for adolescents.
Only the Scholastic Competence domain items are used through a structured alternative format.
Items grouped into the subscale of Scholastic competence in accordance to the master list of items to produce a summed score.
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up to 9 months
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Changes to school records of Academic behaviours
Time Frame: up to 9 months
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School records of behavours, including absences and behavioural sanctions at the school level, in comparison to previous 5 years records.
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up to 9 months
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Changes in BMI
Time Frame: up to 9 months
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Weight measured in kilograms and height in meters to combine to report BMI in kg/m^2
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up to 9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catherine Woods, PhD, University of Limerick
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Postprimary Active School Flag
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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