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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
    • North Yorkshire
      • York, North Yorkshire, United Kingdom, YO31 7EX
        • York St John University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Physical activity programme

The physical activity programme will have the following features:

  • 6-week programme
  • 1-2 supervised physical activity sessions per week
  • 60 minutes per session, including a mixture of physical activities (e.g. walking, other aerobic physical activity, resistance, balance and stretching exercises)
  • Self-selected physical activity intensity
  • Group-based (maximum of 10 students per session)
  • Sessions supervised by a qualified exercise instructor. A member of the University's Wellbeing team will also be present to offer students mental health support, if needed.
  • Physical activity behavioral strategies incorporated into the 6-week programme (e.g., goal setting, action planning, exploring barriers and enablers, setting cues or prompts for self-directed PA)
  • Encouragement to be physically active away from the supervised sessions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
From enrollment to the end of intervention at 6 weeks
Acceptability of the service
Time Frame: At the 6-week follow-up assessment
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
From enrollment to the end of intervention at 6 weeks
Mean time per day in moderate-to-vigorous physical activity
Time Frame: Assessed at baseline and at the 6-week follow-up
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
10-item Recovering Quality of Life (ReQoL) questionnaire
Time Frame: Assessed at baseline and at the 6-week follow-up
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.
Assessed at baseline and at the 6-week follow-up
38-item Mental Health Inventory (MHI-38)
Time Frame: Assessed at baseline and at the 6-week follow-up
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.
Assessed at baseline and at the 6-week follow-up
Resting blood pressure (automated)
Time Frame: Assessed before and after the 6-week intervention period
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
Lower-limb muscular strength/endurance (30-s sit-to-stand test)
Time Frame: Assessed before and after the 6-week intervention period
Assessed before and after the 6-week intervention period
Adverse events
Time Frame: From enrollment to the end of the exit assessment after the end of the 6-week intervention period
From enrollment to the end of the exit assessment after the end of the 6-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
York St John University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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