Physical ActivityPPASFNCT03847831
Feasibility Study of the Pilot Post-primary Active School Flag (PPASF) Program
A study testing Active School Flag Program in people with Physical Activity and Health Behavior, run by University of Limerick at 1 site in Ireland.
Trial summary
The Feasibility of the post-primary Active School Flag (PPASF) programme. The PPASF is an initative from the Department of Education and Skills in a whole-school program to increase physical activity opportunities involving the students in second level education schools in Ireland. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Health Behavior, Health Knowledge, Attitudes, Practice
- What is being tested?
- Active School Flag Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,000 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2018to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- students and teachers in the enrolled schools
Who cannot join
- students and teachers not enrolled in the schools
- students who did not provide consent or assent to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprimary Active School Flag Feasibility
The Feasibility of the post-primary Active School Flag (PPASF) programme. The PPASF is an initative from the Department of Education and Skills in a whole-school program to increase physical activity opportunities involving the students in second level education schools in Ireland. Various actors involved in the process include admin, teachers, and students to create more physical activity opportunities for the students in the school. Process evaluation and fidelity of the program are carried out during the year long process for certificate and two years for achieving the flag. Results of this study will inform the design and implementation of the PPASF in a national roll out across Irish second level education schools.
Read the 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.
- Conditions
- Physical Activity, Health Behavior, Health Knowledge, Attitudes, Practice, Educational Problems
- Being tested
- Active School Flag Program
- Keywords
- whole-school, health promotion
- Medical subject headings
- Motor Activity, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active School Flag ProgramBehavioural
Schools enrolled in the program take part in the 17 actions described in the PPASF.
| Study group | Role | What they receive |
|---|---|---|
| PPASF Group | Experimental | Schools enrolled in the post primary 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. Receives: Behavioral: Active School Flag Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the PPASF programme's components in the schools
Customized fidelity check list based on the 17 program elements.
Measured: up to 9 months
Secondary outcomes (9)
Number of participants in designated areas of school assessed through a modified version of the SOPLAY protocol
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.
Measured: up to 9 months
Changes in physical activity opportunities through questionnaires
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.
Measured: up to 9 months
Changes in physical activity levels by accelerometer
Accelerometers placed on the thigh for a minimum of 4 days (1 weekend day) and at least 10h of wear time per day
Measured: up to 9 months
Changes in physical activity levels by self-reported physical activity through questionnaires
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.
Measured: up to 9 months
Changes in (accelerometer based) sedentary time during the school day
Accelerometers placed on the thigh to measure inclination and algorithm to detect sitting and lying time.
Measured: up to 9 months
Changes to self-reported academic performance
Self-report surveys of perceived academic performance. A four point scale of 'below average' 'average' 'good', 'excellent'.
Measured: up to 9 months
Changes to self-reported academic performance behaviours
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.
Measured: up to 9 months
Changes to school records of Academic behaviours
School records of behavours, including absences and behavioural sanctions at the school level, in comparison to previous 5 years records.
Measured: up to 9 months
Changes in BMI
Weight measured in kilograms and height in meters to combine to report BMI in kg/m^2
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Sep 2018
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomised single-group at school level pilot study.
- Masking
- None (open label)
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwok Ng, University of Limerick
- Investigators
- Catherine Woods, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847831
- Sponsor's protocol ID
- Postprimary Active School Flag
- Acronym
- PPASF
- Status last verified
- May 2024
- First submitted
- 12 Feb 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprimary Active School Flag Feasibility
- ClinicalTrials.gov ID
- NCT03847831
- Acronym / sponsor ID
- PPASF / Postprimary Active School Flag
- Conditions
- Physical Activity, Health Behavior, Health Knowledge, Attitudes, Practice, Educational Problems
- Keywords
- whole-school, health promotion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Feasibility of the post-primary Active School Flag (PPASF) programme. The PPASF is an initative from the Department of Education and Skills in a whole-school program to increase physical activity opportunities involving the students in second level education schools in Ireland. Various actors involved in the process include admin, teachers, and students to create more physical activity opportunities for the students in the school. Process evaluation and fidelity of the program are carried out during the year long process for certificate and two years for achieving the flag. Results of this study will inform the design and implementation of the PPASF in a national roll out across Irish second level education schools.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomised single-group at school level pilot study.
| Arm | Type | Receives |
|---|---|---|
| PPASF Group | Experimental | Behavioral: Active School Flag ProgramSchools enrolled in the post primary 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- students and teachers in the enrolled schools
Key exclusion criteria (2 listed)
- students and teachers not enrolled in the schools
- students who did not provide consent or assent to take part in the study
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 |
|---|---|---|
| Active School Flag ProgramSchools enrolled in the program take part in the 17 actions described in the PPASF. | Behavioural | PPASF Group |
Primary outcome
Adherence to the PPASF programme's components in the schools
Time frame: up to 9 months
Customized fidelity check list based on the 17 program elements.
9 secondary outcomes
Number of participants in designated areas of school assessed through a modified version of the SOPLAY protocol
Time frame: up to 9 months
Changes in physical activity opportunities through questionnaires
Time frame: up to 9 months
Changes in physical activity levels by accelerometer
Time frame: up to 9 months
Changes in physical activity levels by self-reported physical activity through questionnaires
Time frame: up to 9 months
Changes in (accelerometer based) sedentary time during the school day
Time frame: up to 9 months
Changes to self-reported academic performance
Time frame: up to 9 months
Changes to self-reported academic performance behaviours
Time frame: up to 9 months
Changes to school records of Academic behaviours
Time frame: up to 9 months
Changes in BMI
Time frame: up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Open Science Framework LinkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Catherine Woods, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active School Flag Program in people with Physical Activity and Health Behavior, run by University of Limerick at 1 site in Ireland.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 16 May 2024. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adherence to the PPASF programme's components in the schools (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.