Clinical trial NCT06874699: Evaluation of the Exercise for Wellbeing Pathway at York St John University
Official title: On-campus Supervised Physical Activity Programme for University Students Facing Mental Health Challenges: a Feasibility Study Exploring Feasibility, Acceptability, Fidelity and Preliminary Effects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Keywords: Exercise
Physical activity
Anxiety
Psychological distress
Depression
University student
Lead sponsor: York St John University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In autumn 2024, York St John University launched a physical activity programme for university students facing mental health challenges. The purpose of this project is to conduct a mixed-methods evaluative study of this new service over a 6-month period. It is anticipated that 20-40 students will be recruited to the study, which will assess the following: assess the following: feasibility, the extent to which the service can be delivered successfully; acceptability, the extent to which the service is considered appropriate, satisfactory, or attractive by programme recipients and intervention delivery staff; fidelity, the extent to which the key service components (e.g., assessment procedures, physical activity programme) were implemented as planned and adaptations were made; preliminary effects, with relation to physical, mental and social health outcomes.


Eligibility criteria: Inclusion Criteria:

* Student enrolled at York St John University
* Age 18 years and over
* Undertaking a course which requires attendance at York St John University's Lord Mayor's Walk Campus
* Presenting to the student wellbeing team with mild-to-moderate mental health concerns (defined as experiencing symptoms of poor mental health such as feeling depressed or socially isolated, prolonged stress and anxiety, or experiencing academic decline that makes their daily life more difficult but maintain daily functioning) and expressing an interest in enhancing their mental health and daily functioning

Exclusion Criteria:

* Unwilling or unable to provide written informed consent
* Unable to attend (or to participate in) the scheduled physical activity sessions
* Unsuccessful physical activity clearance using the physical activity readiness questionnaire (PAR-Q+)

Primary outcomes:
measure: Rate of recruitment
timeFrame: Over the course of the 6-month enrollment period
measure: Rate of retention
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Rate of attendance
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Acceptability of the service
timeFrame: At the 6-week follow-up assessment
Secondary outcomes:
measure: Fidelity
timeFrame: From enrollment to the end of intervention at 6 weeks
measure: Mean time per day in moderate-to-vigorous physical activity
timeFrame: Assessed at baseline and at the 6-week follow-up
measure: 10-item Recovering Quality of Life (ReQoL) questionnaire
timeFrame: Assessed at baseline and at the 6-week follow-up
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Assessed at baseline and at the 6-week follow-up
measure: 38-item Mental Health Inventory (MHI-38)
timeFrame: Assessed at baseline and at the 6-week follow-up
measure: Resting blood pressure (automated)
timeFrame: Assessed before and after the 6-week intervention period
measure: Estimated maximal oxygen uptake (YMCA submaximal cycle test)
timeFrame: Assessed before and after the 6-week intervention period
measure: Grip strength (Jamar handgrip dynamometer)
timeFrame: Assessed before and after the 6-week intervention period
measure: Lower-limb muscular strength/endurance (30-s sit-to-stand test)
timeFrame: Assessed before and after the 6-week intervention period
measure: Adverse events
timeFrame: From enrollment to the end of the exit assessment after the end of the 6-week intervention period
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: York St John University
state: North Yorkshire
Study officials:
affiliation: York St John University
name: Professor Garry Tew, PhD
role: PRINCIPAL_INVESTIGATOR
References: