Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000265471p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2025
Date registered
10/04/2025
Date last updated
10/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Sedentary Time Elimination with Periodic activity Snacks study in people with mental illness
Scientific title
Sedentary Time Elimination with Periodic activity Snacks study in people with mental illness
Secondary ID [1] 314046 0
Nil known
Universal Trial Number (UTN)
Trial acronym
STEPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bipolar disorder 336791 0
major depressive disorder 336790 0
schizophrenia 336789 0
Condition category
Condition code
Mental Health 333282 333282 0 0
Depression
Mental Health 333283 333283 0 0
Psychosis and personality disorders
Mental Health 333281 333281 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will use an app and wear a wrist-worn Garmin activity tracker for six weeks. The app is designed to prompt users via the Garmin to partake in at least three physical activity “snacks” per day (defined as physical activity bouts of less than 10 minutes in duration). The timing of these prompts will be customisable to the individual, and setup will be supported by a member of the research team during the initial onboarding session. Further support will be provided during weekly follow-up phone calls, during which the research team will assist participants in adjusting preferences, addressing technical issues, and gathering information on ongoing capacity to consent and adverse events.

The mode of each physical activity snack will be personalised according to participants’ physical activity preferences and capabilities. Participants will select their preferred types of activities from either a pre-determined list or may nominate other activities that suit their needs and abilities. This approach ensures that the intervention is accessible and adaptable to a range of physical abilities and lifestyles. We anticipate the pre-determined list to include the following options:
• Walking up and down stairs
• Walking outside
• Housework/household chores
• Other (users will be asked to specify)

Adherence to the intervention will be assessed using data retrieved from the Garmin activity tracker, including timestamps and activity intensity, which will be used to determine whether participants completed at least three short bouts of activity per day. These data will be supplemented by weekly self-reports collected during follow-up phone calls to provide additional context where needed.
Intervention code [1] 330629 0
Lifestyle
Intervention code [2] 330697 0
Treatment: Other
Intervention code [3] 330696 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340855 0
App usability.
Timepoint [1] 340855 0
The system usability scale will be administered at Week 3 (mid-point) and Week 6 (end-point).
Primary outcome [2] 341046 0
Feasibility (study completion rates)
Timepoint [2] 341046 0
Endpoint (week 6).
Primary outcome [3] 340856 0
Feasibility (screening and consent)
Timepoint [3] 340856 0
Feasibility (screening and consent) will be measured pre-baseline.
Secondary outcome [1] 445610 0
All physical activity (as a composite)
Timepoint [1] 445610 0
This data will be collected continuously throughout the study from baseline through to endpoint (end of week 6).
Secondary outcome [2] 445280 0
Sedentary behaviour (mins/day)
Timepoint [2] 445280 0
Baseline and end-point (end of week 6).
Secondary outcome [3] 445281 0
Sedentary behaviour (mins/day)
Timepoint [3] 445281 0
This data will be collected continuously throughout the study from baseline through to endpoint (end of week 6).
Secondary outcome [4] 445608 0
All physical activity (as a composite)
Timepoint [4] 445608 0
Baseline to endpoint (end of week 6)
Secondary outcome [5] 445284 0
Body mass index
Timepoint [5] 445284 0
Baseline and endpoint (end of week 6).
Secondary outcome [6] 445279 0
Physical activity related motivational behaviour
Timepoint [6] 445279 0
The Behavioural Regulation in Exercise Questionnaire 3 will be administered at baseline and end-point (end of week 6)
Secondary outcome [7] 445283 0
Quality of life
Timepoint [7] 445283 0
Baseline and endpoint (end of week 6)
Secondary outcome [8] 445282 0
Psychological distress
Timepoint [8] 445282 0
Baseline and endpoint (end of week 6).
Secondary outcome [9] 445609 0
Moderate-to-vigorous physical activity (composite)
Timepoint [9] 445609 0
This data will be collected continuously throughout the study from baseline through to endpoint (end of week 6).
Secondary outcome [10] 445607 0
Moderate-to-vigorous physical activity (composite measure)
Timepoint [10] 445607 0
Baseline and endpoint (end of week 6)

Eligibility
Key inclusion criteria
Inclusion criteria will include anyone with a diagnosis of either schizophrenia/schizoaffective disorder, major depression, or bi-polar disorder, who are >18years and have capacity to consent as determined by their treating clinician. They are also required to own either an Android or Apple smartphone for app downloading.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not able to provide consent (as determined by their treating clinicians). Having any condition that could be made worse by increasing physical activity.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All data will be managed and stored as per the National Health and Medical Research Council’s Australian Code for the Responsible Conduct of Research guidelines. The acceptability and feasibility of the intervention will be reported using descriptive statistics as means and standard deviations or number and percentages as appropriate. The qualitative data gathered from the end of intervention semi-structured interviews will be analysed using thematic analysis to identify meaningful patterns within the data based on grounded theory, facilitating a deeper and richer understanding of the participants’ experiences. All secondary (pre-post) outcomes will be analysed using either a t-test or Mann’s Whitney U test, dependent on the normality of the data. Effect sizes for secondary outcomes will be calculated as Cohen’s d, based on standard calculations based on mean changes and pooled standard deviations. We will also determine associations between the SIMPAQ and the Garmin physical activity and sedentary behaviour data using the Pearson’s coefficient.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
17/07/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318552 0
Government body
Name [1] 318552 0
Metro South Health Research Support Scheme
Country [1] 318552 0
Australia
Primary sponsor type
Government body
Name
Metro South Addiction and Mental Health Services
Address
Country
Australia
Secondary sponsor category [1] 320949 0
None
Name [1] 320949 0
Address [1] 320949 0
Country [1] 320949 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317152 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317152 0
Ethics committee country [1] 317152 0
Australia
Date submitted for ethics approval [1] 317152 0
01/04/2025
Approval date [1] 317152 0
Ethics approval number [1] 317152 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140174 0
Dr Mike Trott
Address 140174 0
Building 33, Princess Alexandra Hospital, Ipswich Road, Brisbane, 4102, QLD
Country 140174 0
Australia
Phone 140174 0
+61 0402761362
Fax 140174 0
Email 140174 0
[email protected]
Contact person for public queries
Name 140175 0
Mike Trott
Address 140175 0
Building 33, Princess Alexandra Hospital, Ipswich Road, Brisbane, 4102, QLD
Country 140175 0
Australia
Phone 140175 0
+61 7 3271 8660
Fax 140175 0
Email 140175 0
[email protected]
Contact person for scientific queries
Name 140176 0
Mike Trott
Address 140176 0
Building 33, Princess Alexandra Hospital, Ipswich Road, Brisbane, 4102, QLD
Country 140176 0
Australia
Phone 140176 0
+61 7 3271 8660
Fax 140176 0
Email 140176 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.