NCT06874699

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

March 3, 2025

Last Update Submit

September 10, 2025

Conditions

Keywords

ExercisePhysical activityAnxietyPsychological distressDepressionUniversity student

Outcome Measures

Primary Outcomes (4)

  • Rate of recruitment

    The average number of participants recruited per month

    Over the course of the 6-month enrollment period

  • Rate of retention

    The proportion of participants who complete the study

    From enrollment to the end of intervention at 6 weeks

  • Rate of attendance

    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

    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 Outcomes (10)

  • Fidelity

    From enrollment to the end of intervention at 6 weeks

  • Mean time per day in moderate-to-vigorous physical activity

    Assessed at baseline and at the 6-week follow-up

  • 10-item Recovering Quality of Life (ReQoL) questionnaire

    Assessed at baseline and at the 6-week follow-up

  • 9-item Patient Health Questionnaire (PHQ-9)

    Assessed at baseline and at the 6-week follow-up

  • 38-item Mental Health Inventory (MHI-38)

    Assessed at baseline and at the 6-week follow-up

  • +5 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Interventions

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York St John University

York, North Yorkshire, YO31 7EX, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Psychological Well-BeingMotor ActivityAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental DisordersBehavioral Symptoms

Study Officials

  • Professor Garry Tew, PhD

    York St John University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 13, 2025

Study Start

February 27, 2025

Primary Completion

September 10, 2025

Study Completion

September 10, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations