Physical InactivityY-PATH NINCT06242990
The Youth - Physical Activity Towards Health Intervention in Northern Ireland
A study testing Y-PATH NI in people with Physical Inactivity, run by University of Ulster at 1 site in United Kingdom.
Trial summary
The Y-PATH programme is an evidence-based intervention programme that has been found to be successful at increasing levels of physical activity in school children in the Republic of Ireland. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Y-PATH NI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Feb 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools
- Post-primary schools in NI with at least one Year 8 class group commencing in the academic year 2023 will be eligible to take part in the study.
- Schools must have a minimum of one PE period/week timetabled for incoming Year 8 pupils,
- have an indoor sports hall (to facilitate intervention delivery)
- employ a qualified PE teacher (with at least 1 years' experience) to teach PE to the Year 8 class group.
- Pupils
Show all 15Show fewer
- All pupils (male and female) in the Year 8 classes identified by the school, who can take part in PE classes, will be eligible to participate in the study.
- Teachers
- Male and female school staff
- PE specialist teachers (with at least 1 years' experience)
- Staff need to be over 18 years old.
- Parents/Guardians
- Male and female parents/guardians
- aged over 18 years old
- with at least one child participating in the Y-PATH NI intervention.
Who cannot join
- Schools
- Primary schools
- Schools which do not provided a minimum of one PE period/week timetabled for incoming Year 8 pupils,
- Schools without an indoor sports hall (to facilitate intervention delivery)
- Schools that do not employ a qualified PE teacher (with at least 1 years' experience) to teach PE to the Year 8 class group.
- Pupils
Show all 12Show fewer
- Pupils in Year 9 and above
- Pupils who do not take part in PE class (determined by the school)
- Teachers
- Teachers not involved with the Y-PATH NI intervention
- Parents/Guardians
- Not having at least one child who participated in the Y-PATH NI intervention
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Ulster University
Londonderry
McClelland
About this study
Official title: Developing and Feasibility Testing the Youth - Physical Activity Towards Health Intervention in Post-primary Schools in Northern Ireland
The Y-PATH programme is an evidence-based intervention programme that has been found to be successful at increasing levels of physical activity in school children in the Republic of Ireland. The Irish Heart Foundation collaborated with Dublin City University and University College Cork to disseminate the programme nationally. The intervention programme aims to improve physical activity levels of adolescents through education about the importance of physical activity for health and the development of fundamental movement skills, which are basic movements associated with physical activity, such as, catching, throwing, and running. The main aims of the Y-PATH NI study are:
- To explore Y-PATH as an intervention 'template', to lead the development of a research-informed model suitable for feasibility testing in a Northern Ireland context (Y-PATH NI).
- To undertake feasibility testing of the Y-PATH NI multi-component intervention aimed at increasing moderate-to-vigorous physical activity in 11-14 year olds.
- To conduct a process evaluation to determine primarily fidelity, but also acceptance and sustainability of the Y-PATH NI intervention.
- Conditions
- Physical Inactivity
- Being tested
- Y-PATH NI
- Keywords
- Physical Activity, Physical Education, Children, Adolescents
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-PATH NIBehavioural
The Y-PATH NI intervention provides a whole of school approach with student, teacher, parent and guardian components. Student components: Y-PATH resources delivered by physical education teachers (6 lesson plans, resource cards to use as teaching prompts), student handbook. Posters are also displayed in the sports hall/ PE department.
Teacher components: Teachers will receive online and in-person training to deliver the Y-PATH programme. This component also targets all non-specialist PE teachers and includes workshops, information leaflets, development of a physical activity promotion charter and a step challenge.
Parent/guardian components: Information session and leaflets distributed across the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Y-PATH Intervention Group | Experimental | Participants will receive the Y-PATH NI intervention programme which is an adapted form of physical education classes. Receives: Behavioral: Y-PATH NI |
| Control Group | No intervention | Participants will continue to receive their usual physical education classes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of recruiting schools/teachers to take part in the study
Ability to recruit schools/teachers to take part in the study. The research team will record the number of schools invited to take part and the number of schools who agree to participate in the study.
Measured: During recruitment phase, 1-2 months
The feasibility of recruiting pupils to take part in the study
The research team will record the number of pupils who are invited to take part in each of the schools and the number of pupils who are recruited.
Measured: During recruitment phase, 1-2 months
The feasibility of training the teachers
The number of teachers trained will be recorded and teachers complete an evaluation questionnaire to share their opinions on the training.
Measured: After baseline assessments have been completed, up to 2 months
The feasibility of delivering Y-PATH NI in schools
Ability to deliver the intervention per protocol within schools. An intervention fidelity checklist will be completed as part of the process evaluation that will be carried out. The following questions will be included, Were all six Health related activity lesson plans delivered? Did teachers use the digital resources? Did teachers use the resource cards?
Measured: Mid-point and end of study, up to 11 months in total
Acceptability of the Y-PATH NI Intervention to the pupils - self-report measure
Pupils who are allocated to the intervention group will complete a self-report evaluation questionnaire which will ask for their opinions on the study (i.e. whether they enjoyed the study and if they were satisfied with the various components of the study). The scales will range from strongly disagree (1) to strongly agree (5).
Measured: Completed at the mid-point of the study (approximately 3-4 months after baseline)
Acceptability of the Y-PATH NI Intervention to the pupils - focus groups
A sub-sample of pupils will participate in focus groups. The focus group would include 5-8 pupils and will aim to gather views and opinions on the Y-PATH NI intervention. A topic guide has been created for this focus group
Measured: Completed at the mid-point of the study (approximately 3-4 months after baseline)
Acceptability of the Y-PATH NI Intervention to the teachers
Teachers will be asked to participate in an interview at the mid-point of the study and at the end of the study to share their opinions on the Y-PATH NI intervention. A topic guide will be used to guide the interview.
Measured: Completed at the mid-point of the study (approximately 3-4 months after baseline) and at the end of the study ( up to 11 months after baseline)
Acceptability of the Y-PATH NI Intervention to the teachers
Teachers will be asked to complete a questionnaire at the mid-point of the study which asks questions about the acceptability of the intervention. Higher scores will indicate greater acceptability.
Measured: Completed at the mid-point of the study (approximately 3-4 months after baseline)
Acceptability of the Y-PATH NI Intervention to parents/guardians
Parents of pupils who participated in the Y-PATH NI intervention will be invited to take part in an interview at the end of the study to gather their views on the Y-PATH NI intervention.
Measured: Completed at the end of the study, up to 11 months after baseline.
Secondary outcomes (9)
Time spent in total physical activity, light physical activity, moderate-to-vigorous physical activity and sedentary behaviour
Time spent in total physical activity, light physical activity, moderate-to-vigorous physical activity and sedentary behaviour, as measured by accelerometry
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement)
Body Mass Index
Weight (in kilograms) and height (in metres) will be measured at three time points throughout the study and body mass index will be calculated. Weight and height will be combined to report BMI in kg/m^2).
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Proportion of participants meeting physical activity guidelines
Proportion of participants meeting physical activity guidelines determined by self-report questionnaire and accelerometry.
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Enjoyment of physical education
Enjoyment of physical education will be measured using the Factors Influencing Enjoyment of Physical Education Enjoyment (FIPE) scale (Motl et al. 2001). This scale consists of 12 items on a 5-point Likert scale ranging from 1 (dislike a lot) to 5 (enjoy a lot) (range 12 - 60).
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Experiences of physical education
Experiences of physical education will be assessed using a twelve item scale (e.g., I feel the activity I do in my PE class I do very well), with pupils indicating the extent to which they agree with the statement, from 'I don't agree at all' to I completely agree' (Woods et al. 2010). In line with previous research, a cut-off point of 36 will be used to distinguish between negative and positive experiences of PE (Clarke, 2019).
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Self-efficacy for exercise
Self-efficacy will be assessed using the eight-item scale (e.g., I could exercise even if I was tired), with pupils indicating the extent to which the statement is 'very true' to 'not at all true' on a scale of 1 to 4. An average of the eight items gives an overall self-efficacy score between 1 (low self-efficacy) and 4 (high self-efficacy) (Garcia et al. 1998). This instrument has been used in this population previously, including the FifeActive survey (Rowe and Murtagh, 2012).
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Physical self-confidence
The Physical Self-Confidence Scale will be used to assess the self-reported confidence in the adolescents ability to do 15 fundamental movement skills. Each of the skills will be rated on a scale from 1 -10, with 1 indicating no confidence and 10 indicating the participant is 'very confident' at performing each skill.
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Behavioural Regulations in Exercise
The Behavioural Regulations in Exercise questionnaire (BREQ-3) will be used to assess reasons why participants take part in exercise and motivation to take part in exercise. Participants will be asked to rate each item on a scale from 0 (not true for me) to 4 (very true for me). A mean score will be calculated for each of the subscales included in this questionnaire: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation and intrinsic regulation.
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Screen time
Screen time will be assessed using a one item tool, with participants asked to report the total number of hours and minutes per day engaged in screen time over the past week (Moore et al, 2020).
Measured: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start23 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke, Dublin City University, University College Cork
- Responsible party
- Sponsor
- Investigators
- Angela Carlin, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242990
- Sponsor's protocol ID
- REC/23/0045
- Acronym
- Y-PATH NI
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2023
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Feasibility Testing the Youth - Physical Activity Towards Health Intervention in Post-primary Schools in Northern Ireland
- ClinicalTrials.gov ID
- NCT06242990
- Acronym / sponsor ID
- Y-PATH NI / REC/23/0045
- Conditions
- Physical Inactivity
- Keywords
- Physical Activity, Physical Education, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Northern Ireland Chest Heart and Stroke, Dublin City University, University College Cork
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 5 Feb 2024 (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 Y-PATH programme is an evidence-based intervention programme that has been found to be successful at increasing levels of physical activity in school children in the Republic of Ireland. The Irish Heart Foundation collaborated with Dublin City University and University College Cork to disseminate the programme nationally. The intervention programme aims to improve physical activity levels of adolescents through education about the importance of physical activity for health and the development of fundamental movement skills, which are basic movements associated with physical activity, such as, catching, throwing, and running. The main aims of the Y-PATH NI study are:
- To explore Y-PATH as an intervention 'template', to lead the development of a research-informed model suitable for feasibility testing in a Northern Ireland context (Y-PATH NI).
- To undertake feasibility testing of the Y-PATH NI multi-component intervention aimed at increasing moderate-to-vigorous physical activity in 11-14 year olds.
- To conduct a process evaluation to determine primarily fidelity, but also acceptance and sustainability of the Y-PATH NI intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-PATH Intervention Group | Experimental | Behavioral: Y-PATH NIParticipants will receive the Y-PATH NI intervention programme which is an adapted form of physical education classes. |
| Control Group | No intervention | –Participants will continue to receive their usual physical education classes. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Schools
- Post-primary schools in NI with at least one Year 8 class group commencing in the academic year 2023 will be eligible to take part in the study.
- Schools must have a minimum of one PE period/week timetabled for incoming Year 8 pupils,
- have an indoor sports hall (to facilitate intervention delivery)
- employ a qualified PE teacher (with at least 1 years' experience) to teach PE to the Year 8 class group.
Key exclusion criteria (12 listed)
- Schools
- Primary schools
- Schools which do not provided a minimum of one PE period/week timetabled for incoming Year 8 pupils,
- Schools without an indoor sports hall (to facilitate intervention delivery)
- Schools that do not employ a qualified PE teacher (with at least 1 years' experience) to teach PE to the Year 8 class group.
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 |
|---|---|---|
| Y-PATH NIThe Y-PATH NI intervention provides a whole of school approach with student, teacher, parent and guardian components. Student components: Y-PATH resources delivered by physical education teachers (6 lesson plans, resource cards to use as teaching prompts), student handbook. Posters are also displayed in the sports hall/ PE department. Teacher components: Teachers will receive online and in-person training to deliver the Y-PATH programme. This component also targets all non-specialist PE teachers and includes workshops, information leaflets, development of a physical activity promotion charter and a step challenge. Parent/guardian components: Information session and leaflets distributed across the intervention period. | Behavioural | Y-PATH Intervention Group |
Primary outcome
The feasibility of recruiting schools/teachers to take part in the study
Time frame: During recruitment phase, 1-2 months
Ability to recruit schools/teachers to take part in the study. The research team will record the number of schools invited to take part and the number of schools who agree to participate in the study.
The feasibility of recruiting pupils to take part in the study
Time frame: During recruitment phase, 1-2 months
The research team will record the number of pupils who are invited to take part in each of the schools and the number of pupils who are recruited.
The feasibility of training the teachers
Time frame: After baseline assessments have been completed, up to 2 months
The number of teachers trained will be recorded and teachers complete an evaluation questionnaire to share their opinions on the training.
The feasibility of delivering Y-PATH NI in schools
Time frame: Mid-point and end of study, up to 11 months in total
Ability to deliver the intervention per protocol within schools. An intervention fidelity checklist will be completed as part of the process evaluation that will be carried out. The following questions will be included, Were all six Health related activity lesson plans delivered? Did teachers use the digital resources? Did teachers use the resource cards?
Acceptability of the Y-PATH NI Intervention to the pupils - self-report measure
Time frame: Completed at the mid-point of the study (approximately 3-4 months after baseline)
Pupils who are allocated to the intervention group will complete a self-report evaluation questionnaire which will ask for their opinions on the study (i.e. whether they enjoyed the study and if they were satisfied with the various components of the study). The scales will range from strongly disagree (1) to strongly agree (5).
Acceptability of the Y-PATH NI Intervention to the pupils - focus groups
Time frame: Completed at the mid-point of the study (approximately 3-4 months after baseline)
A sub-sample of pupils will participate in focus groups. The focus group would include 5-8 pupils and will aim to gather views and opinions on the Y-PATH NI intervention. A topic guide has been created for this focus group
Acceptability of the Y-PATH NI Intervention to the teachers
Time frame: Completed at the mid-point of the study (approximately 3-4 months after baseline) and at the end of the study ( up to 11 months after baseline)
Teachers will be asked to participate in an interview at the mid-point of the study and at the end of the study to share their opinions on the Y-PATH NI intervention. A topic guide will be used to guide the interview.
Acceptability of the Y-PATH NI Intervention to the teachers
Time frame: Completed at the mid-point of the study (approximately 3-4 months after baseline)
Teachers will be asked to complete a questionnaire at the mid-point of the study which asks questions about the acceptability of the intervention. Higher scores will indicate greater acceptability.
Acceptability of the Y-PATH NI Intervention to parents/guardians
Time frame: Completed at the end of the study, up to 11 months after baseline.
Parents of pupils who participated in the Y-PATH NI intervention will be invited to take part in an interview at the end of the study to gather their views on the Y-PATH NI intervention.
9 secondary outcomes
Time spent in total physical activity, light physical activity, moderate-to-vigorous physical activity and sedentary behaviour
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement)
Body Mass Index
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Proportion of participants meeting physical activity guidelines
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Enjoyment of physical education
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Experiences of physical education
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Self-efficacy for exercise
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Physical self-confidence
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Behavioural Regulations in Exercise
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
Screen time
Time frame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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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.
Angela Carlin, PhD principal investigator
Ulster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y-PATH NI in people with Physical Inactivity, run by University of Ulster at 1 site in United Kingdom.
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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Carlin, PhD (028 71675037, a.carlin1@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of recruiting schools/teachers to take part in the study (time frame: During recruitment phase, 1-2 months). The study lists 9 primary outcomes in all. 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 23 May 2024.