Clinical trial NCT06242990: The Youth - Physical Activity Towards Health Intervention in Northern Ireland
Official title: Developing and Feasibility Testing the Youth - Physical Activity Towards Health Intervention in Post-primary Schools in Northern Ireland
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Keywords: Physical Activity
Physical Education
Children
Adolescents
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Northern Ireland Chest Heart and Stroke
name: Dublin City University
name: University College Cork
First posted: 2024-02-05
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

• 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.

Exclusion Criteria:

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

* 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

Primary outcomes:
measure: The feasibility of recruiting schools/teachers to take part in the study
timeFrame: During recruitment phase, 1-2 months
measure: The feasibility of recruiting pupils to take part in the study
timeFrame: During recruitment phase, 1-2 months
measure: The feasibility of training the teachers
timeFrame: After baseline assessments have been completed, up to 2 months
measure: The feasibility of delivering Y-PATH NI in schools
timeFrame: Mid-point and end of study, up to 11 months in total
measure: Acceptability of the Y-PATH NI Intervention to the pupils - self-report measure
timeFrame: Completed at the mid-point of the study (approximately 3-4 months after baseline)
measure: Acceptability of the Y-PATH NI Intervention to the pupils - focus groups
timeFrame: Completed at the mid-point of the study (approximately 3-4 months after baseline)
measure: Acceptability of the Y-PATH NI Intervention to the teachers
timeFrame: 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)
measure: Acceptability of the Y-PATH NI Intervention to the teachers
timeFrame: Completed at the mid-point of the study (approximately 3-4 months after baseline)
measure: Acceptability of the Y-PATH NI Intervention to parents/guardians
timeFrame: Completed at the end of the study, up to 11 months after baseline.
Secondary outcomes:
measure: Time spent in total physical activity, light physical activity, moderate-to-vigorous physical activity and sedentary behaviour
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement)
measure: Body Mass Index
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
measure: Proportion of participants meeting physical activity guidelines
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
measure: Enjoyment of physical education
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
measure: Experiences of physical education
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
measure: Self-efficacy for exercise
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
measure: Physical self-confidence
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
measure: Behavioural Regulations in Exercise
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement
measure: Screen time
timeFrame: Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement.
Other outcomes:
Locations:
city: Derry / Londonderry
country: United Kingdom
facility: Ulster University
Study officials:
affiliation: Ulster University
name: Angela Carlin, PhD
role: PRINCIPAL_INVESTIGATOR
References: