Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000669897
Ethics application status
Approved
Date submitted
19/04/2021
Date registered
2/06/2021
Date last updated
28/04/2024
Date data sharing statement initially provided
2/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
‘UC-30’ – behavioural nudges to encourage university students to sit less and move more
Scientific title
‘UC-30’ – the effect of behavioural nudges on sedentary behaviour in healthy university students
Secondary ID [1] 303999 0
None
Universal Trial Number (UTN)
Trial acronym
UC-30
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary behaviour 321612 0
Condition category
Condition code
Public Health 319354 319354 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Few studies have focused on reducing sedentary behaviour in university students and none have used choice architecture interventions. Choice architecture interventions, or ‘nudging’, make subtle changes to the micro-environment (university, home, online), disrupting habitual behaviour and motivating the choice for a healthier option. Applied to the physical, social and learning environments, prompts will be embedded in lectures and tutorials encouraging active breaks every 30 minutes of sitting. Posters and brief educational videos will be co-produced with students to provide information on the relationship between sedentary behaviour, health and academic outcomes, including the use of descriptive social norms.

Specifically, at 30-minute intervals throughout a learning activity delivered by a lecturer or tutor (lecture, tutorial - online or face-to-face), students will be presented with a series of options on how to enjoy a 5-minute learning break. The number of times the learning break will be delivered will be different for each student, depending on how many learning activities they engage with. Choice architecture or nudge theory will be used to alter the presentation of these options for the learning break to bias decision making towards those options involving physical activity. For example, the phrasing and ordering of the options, as well as the colours and images used, will all be designed to subtly influence decision making. The options presented to students within the learning activity will be co-designed with students and staff prior to implementation. The research team will regularly check-in (2-4 weekly) with the lecturers and tutors to monitor the use of the learning breaks.

Overall, the aim of the UC-30 repeated ‘nudges’ (learning break options, posters, video) is to disrupt automatic thought processes, helping to develop habits (breaking up sitting) where the behaviour is repeated in daily life within and outside of university study.

Sedentary behaviour outcome measures (self-report, accelerometer) will be collected at the end of semester. Students will be asked to complete a sedentary behaviour online survey and one of the questions will ask if they are willing to wear an accelerometer to objectively measure sedentary behaviour. For this additional component, the first 30 participants that express interest in participating will be asked to wear the monitor on their right hip (match-box size on an elastic waist band), while awake, for 7-consecutive days.
Intervention code [1] 320309 0
Lifestyle
Intervention code [2] 320310 0
Prevention
Comparator / control treatment
In April 2023, a Stepped wedge cluster randomised trial will commence, starting with the UC Faculty of Health that has been exposed to the UC30 intervention (semester 2 2023). Two faculties per semester will then randomly receive the intervention (two in semester 1 2024, two in semester 2 2024), with all faculties receiving the intervention by the end of semester 2 2024. The control group will be the participants in the wait period prior to receiving the intervention, during which usual teaching practices (in-person or online) will occur.

The original cohort study recruited 60 participants in October 2021. The cohort study was completed in April 2022 (pre and post intervention measures). There was no control group.
Control group
Active

Outcomes
Primary outcome [1] 327218 0
Sedentary behaviour (self-report, min/day). The main outcome measure is self-reported sedentary behaviour (min/day) measured using a sedentary behaviour questionnaire validated in a university population (PAST-U questionnaire). The PAST-U is a nine-item instrument that uses past-day recall of sedentary time in hours and minutes while at work, study, travelling, eating and drinking, watching television, using the computer,
socialising and any other daily activities.
Timepoint [1] 327218 0
Outcome measures will be collected at the end of semester 1 and 2 (weeks 11-13) from semester 1 2023 to semester 2 2024.
Secondary outcome [1] 394270 0
Sedentary behaviour (accelerometer, min/day). An ActiGraph GT3X accelerometer will be used to objectively measure sedentary behaviour min/day in a sub-set of participants. Device-measured sedentary behaviour is a more reliable and valid measure of sitting time compared with self-report, which can result in under or overreporting of sitting time, Participants will be given the accelerometer before and after the UC-30 intervention and asked to wear the monitor on their right hip, while awake, for 7-consecutive days.
Timepoint [1] 394270 0
Baseline (weeks 11-13, UC semester 2 2021),
End-intervention (weeks 11-13, UC semester 1 2022).
Secondary outcome [2] 395707 0
Sedentary behaviour (accelerometer, bouts/day). An ActiGraph GT3X accelerometer will be used to objectively measure sedentary behaviour bouts/day in a sub-set of participants. Device-measured sedentary behaviour is a more reliable and valid measure of sitting time compared with self-report, which can result in under or overreporting of sitting time, Participants will be given the accelerometer before and after the UC-30 intervention and asked to wear the monitor on their right hip, while awake, for 7-consecutive days.
Timepoint [2] 395707 0
Baseline (weeks 11-13, UC semester 2 2021),
End-intervention (weeks 11-13, UC semester 1 2022).
Secondary outcome [3] 395708 0
Sedentary behaviour (accelerometer, breaks/day). An ActiGraph GT3X accelerometer will be used to objectively measure sedentary behaviour breaks/day in a sub-set of participants. Device-measured sedentary behaviour is a more reliable and valid measure of sitting time compared with self-report, which can result in under or overreporting of sitting time, Participants will be given the accelerometer before and after the UC-30 intervention and asked to wear the monitor on their right hip, while awake, for 7-consecutive days.
Timepoint [3] 395708 0
Baseline (weeks 11-13, UC semester 2 2021),
End-intervention (weeks 11-13, UC semester 1 2022).

Eligibility
Key inclusion criteria
All University of Canberra students will be eligible for this study. Participants must be 18 years or older, healthy and ambulatory to participate in the study (2023-2024).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students who are less than 18 years of age, self-report they are not ambulatory (eg: wheelchair bound) and are unwell (eg: spending large amounts of time sitting or lying while awake) will be excluded from participating in the study as the intervention aims to decrease
sitting time. Only students and staff from the University of Canberra will be able to participate in this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In 2022, no control group.
In 2023, control groups will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In 2022, no control group.
In 2023, control groups will be used. A Stepped wedge cluster randomised trial will commence, starting with the UC Faculty of Health that has been exposed to the UC30 intervention (semester 2 2023). Two faculties per semester will then randomly receive the intervention (two in semester 1 2024, two in semester 2 2024), with all faculties receiving the intervention by the end of semester 2 2024.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a pilot study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analyses will be completed for outcome measures from the Online survey and accelerometery. For pre-post intervention comparisons, paired t-tests and repeated measures ANOVAs will be used and, if variables are not normally distributed, the Wilcoxon
Signed Ranks and Freedman tests will be used, while the McNemar test will be used for changes in proportions. All analyses will be conducted using either SPSS version 26. Significance level will be set at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/10/2021
Actual
11/10/2021
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
1000
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 33726 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 308381 0
University
Name [1] 308381 0
University of Canberra
Country [1] 308381 0
Australia
Primary sponsor type
Individual
Name
A/Prof Nicole Freene
Address
Physiotherapy, University of Canberra, University Dr, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 309201 0
Individual
Name [1] 309201 0
A/Prof Nick Ball
Address [1] 309201 0
Sport & Exercise Science, University of Canberra, University Dr, Bruce, ACT, 2617
Country [1] 309201 0
Australia
Secondary sponsor category [2] 309203 0
Individual
Name [2] 309203 0
Dr Andrew Flood
Address [2] 309203 0
Psychology, University of Canberra, University Dr, Bruce, ACT, 2617
Country [2] 309203 0
Australia
Secondary sponsor category [3] 309204 0
Individual
Name [3] 309204 0
Dr Jaqi Bousie
Address [3] 309204 0
Physiotherapy, University of Canberra, University Dr, Bruce, ACT, 2617
Country [3] 309204 0
Australia
Secondary sponsor category [4] 309205 0
Individual
Name [4] 309205 0
Prof Mark Naunton
Address [4] 309205 0
Pharmacy, University of Canberra, University Dr, Bruce, ACT, 2617
Country [4] 309205 0
Australia
Secondary sponsor category [5] 309206 0
Individual
Name [5] 309206 0
Dr Lynn Cheong
Address [5] 309206 0
Pharmacy, University of Canberra, University Dr, Bruce, ACT, 2617
Country [5] 309206 0
Australia
Secondary sponsor category [6] 309207 0
Individual
Name [6] 309207 0
Dr Reza Mortazavi
Address [6] 309207 0
Faculty of Health, University of Canberra, University Dr, Bruce, ACT, 2617
Country [6] 309207 0
Australia
Secondary sponsor category [7] 309208 0
Individual
Name [7] 309208 0
Dr Sally De-Vitry Smith
Address [7] 309208 0
Midwifery, University of Canberra, University Dr, Bruce, ACT, 2617
Country [7] 309208 0
Australia
Secondary sponsor category [8] 309209 0
Individual
Name [8] 309209 0
Prof Rachel Davey
Address [8] 309209 0
Health Research Institute, University of Canberra, University Dr, Bruce, ACT, 2617
Country [8] 309209 0
Australia
Secondary sponsor category [9] 309210 0
Individual
Name [9] 309210 0
Ms Alice Martin
Address [9] 309210 0
Physiotherapy, University of Canberra, University Dr, Bruce, ACT, 2617
Country [9] 309210 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308346 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 308346 0
Ethics committee country [1] 308346 0
Australia
Date submitted for ethics approval [1] 308346 0
09/02/2021
Approval date [1] 308346 0
10/03/2021
Ethics approval number [1] 308346 0
Project number 6973

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

Contacts
Principal investigator
Name 110390 0
A/Prof Nicole Freene
Address 110390 0
Physiotherapy, University of Canberra, University Dr, Bruce, ACT 2617
Country 110390 0
Australia
Phone 110390 0
+61 2 6201 5550
Fax 110390 0
Email 110390 0
[email protected]
Contact person for public queries
Name 110391 0
Nicole Freene
Address 110391 0
Physiotherapy, University of Canberra, University Dr, Bruce, ACT 2617
Country 110391 0
Australia
Phone 110391 0
+61 2 6201 5550
Fax 110391 0
Email 110391 0
[email protected]
Contact person for scientific queries
Name 110392 0
Nicole Freene
Address 110392 0
Physiotherapy, University of Canberra, University Dr, Bruce, ACT 2617
Country 110392 0
Australia
Phone 110392 0
+61 2 6201 5550
Fax 110392 0
Email 110392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Sedentary behaviour outcomes (self-report min/day, accelerometer min/day, accelerometer bout/day, accelerometer break/day) and socio-demographic variables (eg: age, sex)
When will data be available (start and end dates)?
2025 onwards for 5 years.
Available to whom?
Researchers interested in sedentary behaviour within university populations.
Available for what types of analyses?
Statistical.
How or where can data be obtained?
De-identified data for this trial will be available upon request by emailing the principal investigator: [email protected]


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.