NCT06242990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

February 23, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 23, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

November 29, 2023

Last Update Submit

May 21, 2024

Conditions

Keywords

Physical ActivityPhysical EducationChildrenAdolescents

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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?

    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).

    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

    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.

    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.

    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.

    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

    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

    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

    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

    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

    Measured at baseline, mid point (approximately 3- 4 months after baseline) and at the final follow up (up to 11 months after baseline measurement

  • +4 more secondary outcomes

Study Arms (2)

Y-PATH Intervention Group

EXPERIMENTAL

Participants will receive the Y-PATH NI intervention programme which is an adapted form of physical education classes.

Behavioral: Y-PATH NI

Control Group

NO INTERVENTION

Participants will continue to receive their usual physical education classes.

Interventions

Y-PATH NIBEHAVIORAL

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.

Y-PATH Intervention Group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulster University

Londonderry, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Angela Carlin, PhD

    Ulster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Carlin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2023

First Posted

February 5, 2024

Study Start

February 23, 2024

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

May 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations