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Completed

NCT Number: NCT06874699

Evaluation of the Exercise for Wellbeing Pathway at York St John University

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.

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Key information

Conditions

Mental Health Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Motor Activity Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York St John University

York, North Yorkshire, YO31 7EX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+)

Treatment and study plan

Physical activity programme

Behavioral

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

Primary outcomes

  1. Rate of recruitment

    Time frame: Over the course of the 6-month enrollment period

    The average number of participants recruited per month

  2. Rate of retention

    Time frame: From enrollment to the end of intervention at 6 weeks

    The proportion of participants who complete the study

  3. 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

  4. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. Resting blood pressure (automated)

    Time frame: Assessed before and after the 6-week intervention period

  7. Estimated maximal oxygen uptake (YMCA submaximal cycle test)

    Time frame: Assessed before and after the 6-week intervention period

  8. Grip strength (Jamar handgrip dynamometer)

    Time frame: Assessed before and after the 6-week intervention period

  9. Lower-limb muscular strength/endurance (30-s sit-to-stand test)

    Time frame: Assessed before and after the 6-week intervention period

  10. Adverse events

    Time frame: From enrollment to the end of the exit assessment after the end of the 6-week intervention period

Sponsors and collaborators

Lead sponsor

York St John University

Other

Registry information

Official study title

On-campus Supervised Physical Activity Programme for University Students Facing Mental Health Challenges: a Feasibility Study Exploring Feasibility, Acceptability, Fidelity and Preliminary Effects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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