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Trial registered on ANZCTR
Registration number
ACTRN12624001076561
Ethics application status
Approved
Date submitted
9/08/2024
Date registered
5/09/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Peer-Led Exercise Program for University of Newcastle Students
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Scientific title
Feasibility of a Peer-Led Exercise Program for University of Newcastle Students
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Secondary ID [1]
312728
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Physical inactivity
334749
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Condition category
Condition code
Physical Medicine / Rehabilitation
331308
331308
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0
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Other physical medicine / rehabilitation
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Public Health
331309
331309
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will undergo a 6-week exercise program, delivered in groups of up to 10 by exercise physiology/exercise science students. The program will be overseen by an Accredited Exercise Physiologist. Participants will complete two 45-minute supervised sessions per week, which will include exercise and psychoeducation. The two sessions will ideally be separated by at least 24 hours. Participants will be provided with an individualised exercise program to complete outside of these sessions; the duration, frequency, intensity and type of these will be individualised to the participants' goals and preferences.
The exercise sessions will include aerobic and resistance training, targeting all major muscle groups using body weight, free weight, and machine-based exercise. The intensity of the sessions will vary depending on the participants' goals, abilities and preferences, but will be of at least a moderate intensity (i.e., Borg 4-6/10). While the exercises will be prescribed with a view to gain mental and physical health benefits, a focus will be placed on correct technique and use of equipment, varying exercise based on goals, and finding different ways of being active.
In addition to the exercise, the participants will receive psychoeducation during their sessions. The Counselling and Psychological services staff will develop a suite of topics to be covered including benefits of exercise on mental health and wellbeing and academic functionality, overcoming barriers to exercise, and goal setting. These staff members will provide the exercise physiology/exercise science student facilitators with training to deliver this information during the sessions in the two weeks prior to the start of the intervention; these training sessions will be a single two hour session either in-person or via Zoom. These will be delivered in tandem with the exercise sessions (i.e., whilst the participants are exercising) via group discussions, rather than separately before or after.
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Intervention code [1]
329249
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Lifestyle
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Determined by recruitment (will students enrol in an exercise program), attendance (will students attend the training sessions), retention (will students complete the program) and participant acceptability (will the student participants and facilitators be amenable to this program approach). This will be assessed via audits of study records, attendance lists, and surveys/focus groups.
Both the participants and student facilitators will be invited to partake in focus groups at the conclusion of the program; participation in these is optional, with the aim to recruit 10 participants and two student facilitators. The focus group questions will centre on their experiences in the program, satisfaction, ongoing barriers/enablers to exercise participation, and their willingness to participate in the future. These will be conducted face-to-face or via Zoom, with a member of the research team. A thematic evaluation of the focus group recordings will be conducted.
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Timepoint [1]
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At the conclusion of the program.
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Secondary outcome [1]
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Mental wellbeing
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Assessment method [1]
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Warwick-Edinburgh Mental Well-Being Scale
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Timepoint [1]
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Change from baseline to follow-up (6 weeks post-commencement of intervention)
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Secondary outcome [2]
438466
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Psychological distress
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Assessment method [2]
438466
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Kessler Psychological Distress Scale (K10)
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Timepoint [2]
438466
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Change from baseline to follow-up (6 weeks post-commencement of intervention)
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Secondary outcome [3]
438467
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Exercise self-efficacy
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Assessment method [3]
438467
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Exercise Self-Efficacy Scale
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Timepoint [3]
438467
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Change from baseline to follow-up (6 weeks post-commencement of intervention)
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Secondary outcome [4]
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Social connectedness
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Assessment method [4]
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Social Connectedness Scale
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Timepoint [4]
438468
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Change from baseline to follow-up (6 weeks post-commencement of intervention)
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Secondary outcome [5]
438469
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Physical activity levels
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Assessment method [5]
438469
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Long-form International Physical Activity Questionnaire
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Timepoint [5]
438469
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Change from baseline to follow-up (6 weeks post-commencement of intervention)
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Secondary outcome [6]
438470
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Handgrip strength
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Assessment method [6]
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Handgrip dynamometer
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Timepoint [6]
438470
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Change from baseline to follow-up (6 weeks post-commencement of intervention)
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Eligibility
Key inclusion criteria
Students currently enrolled at the University of Newcastle, Australia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
People will be ineligible if they have any condition as per the absolute contraindications to exercise, are meeting the physical activity guidelines (150minutes/week moderate intensity or 75minutes/week vigorous intensity exercise), have severe mental illness (e.g., psychoses), have planned medical operations during the research period, are pregnant or expecting to be pregnant during the study period, and are non-English speaking. People will also be ineligible if they are enrolled in a degree within the Exercise and Sport Science discipline.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/08/2024
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Date of last participant enrolment
Anticipated
4/08/2025
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Actual
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Date of last data collection
Anticipated
31/10/2025
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Actual
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Sample size
Target
40
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
317156
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University
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Name [1]
317156
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University of Newcastle
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Address [1]
317156
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Country [1]
317156
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Australia
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Primary sponsor type
University
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Name
The University of Newcastle
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Address
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Country
Australia
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Secondary sponsor category [1]
319425
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None
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Name [1]
319425
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Address [1]
319425
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Country [1]
319425
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315906
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [1]
315906
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http://www.newcastle.edu.au/research/research-services/human-ethics/
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Ethics committee country [1]
315906
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Australia
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Date submitted for ethics approval [1]
315906
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Approval date [1]
315906
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12/03/2024
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Ethics approval number [1]
315906
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Summary
Brief summary
This will be a pilot trial involving 40 students currently enrolled at the University of Newcastle. After providing written informed consent, participants will be sent several questionnaires to complete at baseline. Participants will then participate in twice weekly exercise/psychoeducation sessions that are facilitated by exercise physiology/exercise science students (under the supervision of an Accredited Exercise Physiologist). Participants will also be provided with an individualised exercise program to complete outside of the supervised sessions. At the end of the training period, Participants will be sent the same questionnaires as baseline to complete. Participants and their peer facilitators will be asked to complete a feedback survey and be invited to participate in focus groups to describe their experiences in the program.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Emily Cox
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Address
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University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
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Country
136170
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Australia
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Phone
136170
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+61 2 4985 4515
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Fax
136170
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Email
136170
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[email protected]
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Contact person for public queries
Name
136171
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Emily Cox
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Address
136171
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University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
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Country
136171
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Australia
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Phone
136171
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+61 2 4985 4515
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Fax
136171
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Email
136171
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[email protected]
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Contact person for scientific queries
Name
136172
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Emily Cox
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Address
136172
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University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
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Country
136172
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Australia
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Phone
136172
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+61 2 4985 4515
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Fax
136172
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Email
136172
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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