Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001432707
Ethics application status
Approved
Date submitted
19/09/2022
Date registered
8/11/2022
Date last updated
8/11/2022
Date data sharing statement initially provided
8/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fit 4 Study: Creating healthy habits through physical activity and exercise for University Students
Scientific title
Fit 4 study: Investigating the effect of a 4-week, behaviour-change informed physical activity intervention on mental health and wellbeing in first-year undergraduate university students
Secondary ID [1] 307652 0
NIL
Universal Trial Number (UTN)
Trial acronym
F4S
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 327168 0
Depression 327169 0
Anxiety-related Disorders 327170 0
Stress 327171 0
Loneliness 327172 0
Psychological Distress 327173 0
Mental wellbeing 327174 0
Condition category
Condition code
Mental Health 324305 324305 0 0
Anxiety
Mental Health 324306 324306 0 0
Depression
Mental Health 324307 324307 0 0
Other mental health disorders
Public Health 324703 324703 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Fit 4 Study program will be delivered in small groups (e.g., up to 10 students with at least 2 facilitators) through online methods (e.g. zoom) or in person on the campus of The University of Queensland. In-person sessions will take place either in the School of Human Movement and Nutrition Science gym or other parts of The University of Queensland campus with outdoor exercise facilities. The intervention involves only one phase which will span 4-weeks, with one session occurring each week. Participants are asked to provide written consent prior to their participation in the intervention.

The Sharper Minds project aims to provide several mental health resources to undergraduate students, so that they are equipped with coping strategies via the interventions provided. As part of the Sharper Minds Project, the Fit 4 Study (physical activity) program is delivered alongside other interventions focusing on areas of sleep (Better Sleep), diet (Food 4 Brain), music (Tuned-In), resilience training (GRUNT), and group belonging training (Groups4Education). All arms of the Sharper Minds program will run simultaneously. Thus, this is a non-randomised trial where participants are required to opt in to their choice of program. To avoid confounding effects of multiple interventions, participants are only allowed to choose one of the arms.

The Fit 4 Study program is comprised of both synchronous and asynchronous activities for participants. The asynchronous content, developed specifically for this course, is provided via a website link (provided under "trial website"), which comprises of up to 20 minutes of recorded content for participants to watch in their own time.

Description of topics covered in Asynchronous Content:
Week 1
- Definition and recommended levels of Physical Activity
- Benefits of Exercise
- Introduction to Transtheoretical Model of Behaviour Change
- How to track physical activity intensity
- How to breathe when engaging in physical activity
Week 2
- What is anaerobic exercise?
- What is aerobic exercise?
- Explanation of High Intensity Interval Training (HIIT), including benefits of HIIT (e.g. exercises performed at a high intensity for short periods of time. Benefits include: (1) able to complete routine in short amount of time; (2) no equipment needed; (3) research shows that people seem to stick with it; (4) improved V02 max, which improves the intensity someone can work at; (5) burns are much calories as traditional cardiovascular-based exercise.
- Machine-based Cardio exercises (e.g. treadmill, rower, step-up machine, assault bike, etc.)
- Bodyweight cardio exercises (e.g. high knees, mountain climbers, burpees, etc.)
Week 3
- Physical Activity focused on getting stronger
- Bodyweight exercises and its benefits (e.g. convenient, cost-effective, improves function and mobility, easily adjustable, works multiple muscles at once)
- Free weight exercises and its benefits (e.g. increase muscle size and strength, great for strengthening muscles that stabilise our body core, helps prevent injuries to body, each exercise has many different variations)
- Machines and its benefits (e.g. easy to use, focuses on specific muscle groups, safer and reduced risk of injury, no set up required, easy to adjust weight/resistance)
- FIIT principles (Frequency, Intensity, Time, and Type)
- Frequency refers to the number of times individuals engage in physical activity. Frequency is important for finding a balance that provides enough stress for the body to adapt but also allows time for healing. Recommended frequency for novice is 2-3 days, and 4-6 days for advanced individuals
- Intensity refers to how hard you work your body during physical activity. Appropriate intensity is required to grow in strength and see changes while reducing risk of injury
- Time refers to the time of day when you engage in physical activity and the duration of each session
- Type refers to the type of physical activity you are doing. There are 4 broad categories: endurance, strength, balance, and flexibility (which are covered in the Fit 4 Study program)
- Muscular Endurance training definition and uses
- Hypertrophy training definition and uses
- Strength training definition and uses
- Power training definition and uses
- How to create a balanced physical activity program and the importance of having a balanced program (e.g. tips on how to balance different types of physical activity in one session)
Week 4
- What is stretching? Benefits of stretching include keeping bodies flexible, maintaining strength in muscles, keeping joints healthy, in order to improve mobility and posture, and reduce risk of injuries and muscle soreness
- Types of stretching can be categorised into static and dynamic stretching. Static stretches are more appropriate for cool downs while dynamic stretches are used for warm ups
- What is balance? Benefits of having good balance include: stable joints, improved coordination, prevention of falls and injuries, and improves reaction time
- Types of balance exercises include single led exercises on various types of surfaces, having both feet together, standing in tandem, and any exercise on a challenging surface.

The synchronous content is run once a week on an online platform (e.g. zoom) or face to face small group discussion, which will be led by 2 facilitators (at least one accredited physiotherapist or exercise physiologist will oversee the physical activity-related activities. Both facilitators have experience in behaviour change). These group discussions focus on applying the content learned in the short videos and utilising strategies for adoption and long-term maintenance of physical activities. Discussions aims to identify potential barriers and enablers to Physical Activity. The facilitators work with the students to develop brief strategies based on behavioural change techniques to overcome barriers and maintain enablers to physical activity. Examples of this content will include behavioural change strategies aimed to help students begin or take on physical activity despite their busy academic expectations and commitments. The synchronous sessions will run for 60 minutes. Adherence to the program will be monitored using an attendance sheet.


Week-by-week description of the Synchronous component of the Fit 4 Study program:
Week 1
- Introduction and rapport building
- Discussions about their current understanding of physical activity and sedentary behaviour and how to measure these behaviours
- Gather reflections of participants based on asynchronous content
- Allow for questions about types of static exercises and provide guidance on how to breathe when engaging in said exercises
- Have discussions about the transtheoretical model of behaviour change and facilitate conversations surrounding participants' past successes and failures on behaviour change
- Participants are required to set an individual physical activity goal
- Examples of exercise for the week: bodyweight squats, push-ups, front planks

Week 2
- Facilitate discussions on how participants went with achieving their physical activity goal from week 1. Consolidate reasons for why some were able to reach their goals and why some were not able to
- Introduce SMART goals (Specific, Measurable, Achievable, Realistic, Time). Help participants see whether the barriers they brought up earlier could be addressed by SMART goals
- Allow time to reframe participants' individual physical activity goals from week 1 and add in more detail based on SMART principles
- Reflections about asynchronous content from week 2
- Examples of exercise for the week: HIIT circuit - 30 seconds of exercise with 20 seconds of rest. 5 sets in total, with 1 min of rest between each set. Exercises include: push ups, crunches, mountain climbers, burpees, squat jumps, etc.)

Week 3
- Check if participants were able to introduce aerobic or anaerobic exercises during the physical activity routine
- Recap of asynchronous content and allow time for participants to ask specific questions about the different types of strength-building exercises they wish to participate in
- Facilitate discussions about barriers and enablers to physical activity that participants have been experiencing.
- Come up with individualised strategies to overcome barriers identified and create more opportunities for enablers to promote physical activity
- Examples of exercises for the week: forward lunges, thread the needles, variations of push ups.

Week 4
- Check if participants had tried out strength-based physical activity to their routines
- Recap of online content on flexibility and balance
- Discussions on how participants have been settling into their physical activity routine and how to maintain new habit
- Reflection of entire program
- Examples of exercises for the week: warm up stretches (e.g. wide hamstring stretch, high knees, dynamic stretches). Cool down stretches (e.g. calf stretch, chest stretch, glute stretch, spinal rolls). Yoga and tai chi poses. Balance tasks (e.g. tandem stance, single leg stance, single leg stance on unstable surface).
Intervention code [1] 324126 0
Prevention
Intervention code [2] 324127 0
Lifestyle
Intervention code [3] 324128 0
Behaviour
Comparator / control treatment
A no-treatment control group part of the parent study of Sharper Minds, will be included as a comparator group (complete the same survey at beginning and end of semester). The participants from the no-treatment control group opt in for this choice and are only invited to complete the outcome surveys (pre- and post-) at the same time as participants in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 332127 0
Short Warwick Edinburgh Mental Wellbeing Measure
Timepoint [1] 332127 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)
Primary outcome [2] 332128 0
PsyCheck measure (20-item questionnaire measuring of psychological distress)

Each item is has two levels (Yes, No):
Depression (item 9, item 11, item 14, item 16); Anxiety (item 4, item 5, item 6, item 12); Somatic (item 1, item 2, item 7, item 19); Cognitive (item 20, item 18, item 8, item 3).

For each mental health condition, scores of > 3 indicate presence of symptoms. (e.g., scoring YES for items 9, 11, 14, and 16 would indicate presence of depressive symptoms)
Timepoint [2] 332128 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)
Primary outcome [3] 332129 0
Causes of Stress (20-item purpose written measure, including COVID-19 & general causes of stress).
Timepoint [3] 332129 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)
Secondary outcome [1] 412302 0
Loneliness (Roberts Version of the UCLA Loneliness scale; RULS-8)
Timepoint [1] 412302 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)
Secondary outcome [2] 412303 0
Physical Activity (Active Australia Survey)
Timepoint [2] 412303 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)
Secondary outcome [3] 412304 0
Sedentary Behaviour (Past Day-Recall of Sedentary Time for University Students; PAST-U)
Timepoint [3] 412304 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)
Secondary outcome [4] 412306 0
Academic Outcomes (GPA) acquired through university records.
Timepoint [4] 412306 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)
Secondary outcome [5] 412307 0
Social Group Belonging (23-item social group belonging & purpose written items)
Timepoint [5] 412307 0
Baseline (before intervention begins), and post-intervention (immediately after intervention is completed)

Eligibility
Key inclusion criteria
Participants must be undergraduate Students enrolled in a first-year course at The University of Queensland.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Currently engaged in treatment for a serious mental health issue (such as clinical depression, bipolar disorder, eating disorder, psychosis)
2. An inability to attend all four of the program sessions
3. English proficiency that is insufficient for the student to engage in the group discussions and complete the assessments (with optional support from the researchers).
4. Currently participating in one of the other branches of the Sharper Minds program (eating, sleep, music, resilience training, social group belonging, control).


Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants opt in for the Fit 4 Study program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed-ANCOVA will be run:
A within time: pre, post, follow up ANCOVA will be conducted to examine whether the program is associated with an improvement in mental health and wellbeing, and physical activity participation, over time and will control for variables such as age, gender. The mental health and wellbeing measures include psychological wellbeing, symptoms of depression, anxiety, somatic symptoms, loneliness, and group belonging. Measures of physical activity and sedentary behaviour will also be included as dependent variables. A between-subjects ANCOVA will also be conducted to examine the impact of Fit 4 Study in comparison to the comparator (music, eating, resilience, social groups, and sleep) and no-treatment control group to determine the relative change of Fit 4 study, when compared to other branches of the Sharper Minds program and a no-treatment control group.

Variables like age, gender and ethnicity will also be used to interpret the data to ensure it is representative of the greater first year population, this will ensure potential bias in the results can be reported as a limitation.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
21/10/2024
Actual
Date of last data collection
Anticipated
16/11/2024
Actual
Sample size
Target
75
Accrual to date
47
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23174 0
University of Queensland - St Lucia
Recruitment postcode(s) [1] 38537 0
4072 - St Lucia

Funding & Sponsors
Funding source category [1] 312029 0
Commercial sector/Industry
Name [1] 312029 0
Allianz Insurance
Country [1] 312029 0
Australia
Funding source category [2] 312030 0
University
Name [2] 312030 0
The University of Queensland DVCA
Country [2] 312030 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Attn: A/Prof Genevieve Dingle
School of Psychology
McElwain Building (24A)
The University of Queensland
St Lucia campus, QLD, 4072
Country
Australia
Secondary sponsor category [1] 313531 0
None
Name [1] 313531 0
Address [1] 313531 0
Country [1] 313531 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311349 0
University of Queensland Human Research Ethics
Ethics committee address [1] 311349 0
Human Research Ethics - Low and Negligible Risk
Health and Behavioural Sciences
Level 4, Social Sciences Building (24)
The University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 311349 0
Australia
Date submitted for ethics approval [1] 311349 0
15/02/2021
Approval date [1] 311349 0
16/03/2021
Ethics approval number [1] 311349 0
2021/HE000275

Summary
Brief summary
Physical activity has the potential to improve the mental health and wellbeing of university students. Given the high prevalence of mental ill health diagnoses in university students when compared to individuals from other age groups, the Fit 4 Study program aims to use physical activity to help first-year undergraduate university students manage their experiences of psychological wellbeing, symptoms of depression, anxiety, somatic symptoms, loneliness, increase their use of physical activity, decrease amount of time spent engaging in sedentary behaviour, improve their academic performance (GPA), and bring benefits to their social group belonging.
Trial website
https://express.adobe.com/page/0JxF3qbeQTPfM/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120806 0
Dr Sjaan Gomersall
Address 120806 0
The University of Queensland, Brisbane, QLD 4067
School of Human Movement and Nutrition Sciences
Country 120806 0
Australia
Phone 120806 0
+61 7 3365 4528
Fax 120806 0
Email 120806 0
s.gomersall1@uq.edu.au
Contact person for public queries
Name 120807 0
Mr Kevin Huang
Address 120807 0
The University of Queensland, Brisbane, QLD 4067
School of Human Movement and Nutrition Sciences
Country 120807 0
Australia
Phone 120807 0
+61452291052
Fax 120807 0
Email 120807 0
k.j.huang@uq.edu.au
Contact person for scientific queries
Name 120808 0
Mr Kevin Huang
Address 120808 0
The University of Queensland, Brisbane, QLD 4067
School of Human Movement and Nutrition Sciences
Country 120808 0
Australia
Phone 120808 0
+61452291052
Fax 120808 0
Email 120808 0
k.j.huang@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The final cleaned data set with all de-identified individual participant data collected during the trial or a subset that is relevant to the data request.
When will data be available (start and end dates)?
Data available after publication of main results until 5 years post-publication
Available to whom?
Other researchers by request
Available for what types of analyses?
Reviews with meta analyses
How or where can data be obtained?
Data on the UQ Research Data Management system will be made available by emailing the principal investigator and contact person: s.gomersall1@uq.edu.au OR k.j.huang@uq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16747Ethical approval    384437-(Uploaded-05-10-2022-13-07-01)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.