- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874699
Evaluation of the Exercise for Wellbeing Pathway at York St John University
September 10, 2025 updated by: York St John University
On-campus Supervised Physical Activity Programme for University Students Facing Mental Health Challenges: a Feasibility Study Exploring Feasibility, Acceptability, Fidelity and Preliminary Effects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Yorkshire
-
York, North Yorkshire, United Kingdom, YO31 7EX
- York St John University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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+)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
This group will comprise of university students who are enrolled on the Exercise for Wellbeing pathway and who have consented to participate in this evaluative study.
|
The physical activity programme will have the following features:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of recruitment
Time Frame: Over the course of the 6-month enrollment period
|
The average number of participants recruited per month
|
Over the course of the 6-month enrollment period
|
|
Rate of retention
Time Frame: From enrollment to the end of intervention at 6 weeks
|
The proportion of participants who complete the study
|
From enrollment to the end of intervention at 6 weeks
|
|
Rate of attendance
Time Frame: From enrollment to the end of intervention at 6 weeks
|
Median number of supervised physical activity sessions attended amongst all participants
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From enrollment to the end of intervention at 6 weeks
|
|
Acceptability of the service
Time Frame: At the 6-week follow-up assessment
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The extent to which the service is considered appropriate, satisfactory, or attractive by programme recipients and intervention delivery staff.
Assessed primarily via one-to-one interviews and an exit survey.
|
At the 6-week follow-up assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fidelity
Time Frame: From enrollment to the end of intervention at 6 weeks
|
The extent to which the key service components (e.g., assessment procedures, physical activity programme) were implemented as planned and adaptations were made.
Assessed primarily via session record data and post-intervention interviews with participants and service delivery staff.
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From enrollment to the end of intervention at 6 weeks
|
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Mean time per day in moderate-to-vigorous physical activity
Time Frame: Assessed at baseline and at the 6-week follow-up
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Assessed using an Axivity AX6 wrist-worn accelerometer worn continuously for 7 days at each study timepoint
|
Assessed at baseline and at the 6-week follow-up
|
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10-item Recovering Quality of Life (ReQoL) questionnaire
Time Frame: Assessed at baseline and at the 6-week follow-up
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The minimum index score for ReQoL-10 is 0 and the maximum is 40, where 0 indicates poorest quality of life and 40 indicates highest quality of life.
|
Assessed at baseline and at the 6-week follow-up
|
|
9-item Patient Health Questionnaire (PHQ-9)
Time Frame: Assessed at baseline and at the 6-week follow-up
|
The total score ranges from 0 to 27 with higher scores indicating more severe depression.
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Assessed at baseline and at the 6-week follow-up
|
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38-item Mental Health Inventory (MHI-38)
Time Frame: Assessed at baseline and at the 6-week follow-up
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All the MHI items are scored on a six-point scale (1-6) except for items 9 and 28, which are scored on a five-point scale (1-5).
The raw score range is 38-226, with higher scores on the Mental Health Index indicating less psychological distress and greater psychological well-being.
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Assessed at baseline and at the 6-week follow-up
|
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Resting blood pressure (automated)
Time Frame: Assessed before and after the 6-week intervention period
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Assessed before and after the 6-week intervention period
|
|
|
Estimated maximal oxygen uptake (YMCA submaximal cycle test)
Time Frame: Assessed before and after the 6-week intervention period
|
Assessed before and after the 6-week intervention period
|
|
|
Grip strength (Jamar handgrip dynamometer)
Time Frame: Assessed before and after the 6-week intervention period
|
Assessed before and after the 6-week intervention period
|
|
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Lower-limb muscular strength/endurance (30-s sit-to-stand test)
Time Frame: Assessed before and after the 6-week intervention period
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Assessed before and after the 6-week intervention period
|
|
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Adverse events
Time Frame: From enrollment to the end of the exit assessment after the end of the 6-week intervention period
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From enrollment to the end of the exit assessment after the end of the 6-week intervention period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Professor Garry Tew, PhD, York St John University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2025
Primary Completion (Actual)
September 10, 2025
Study Completion (Actual)
September 10, 2025
Study Registration Dates
First Submitted
March 3, 2025
First Submitted That Met QC Criteria
March 7, 2025
First Posted (Actual)
March 13, 2025
Study Record Updates
Last Update Posted (Estimated)
September 17, 2025
Last Update Submitted That Met QC Criteria
September 10, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETH2425-0237
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Anonymised IPD may be shared on the University's data repository, RaYDaR.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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