Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000462482
Ethics application status
Approved
Date submitted
29/03/2016
Date registered
8/04/2016
Date last updated
6/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of motivational, self-regulatory and automatic processes in a computer-tailored physical activity intervention for hospital staff.
Scientific title
Comparing efficacy of motivational, self-regulatory and automatic processes in a computer-tailored interventions for increasing physical activity levels in hospital staff.
Secondary ID [1] 288037 0
None
Universal Trial Number (UTN)
Trial acronym
Physical Activity Tailored intervention in Hospital Staff (PATHS) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 296899 0
Work-related stress 296900 0
Condition category
Condition code
Public Health 297131 297131 0 0
Health promotion/education
Public Health 297134 297134 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants: Nurses, midwifes and patient assistants (N = 168) will be recruited from four hospitals in Perth, Western Australia. Intervention: Participants will be randomised to one of the three intervention conditions including different behaviour change techniques (BCTs): (1) motivational, (2) motivational and self-regulatory, (3) motivational, self-regulatory and habit formation, all an online behavioural intervention to encourage physical activity in their own time.
There will be six fortnightly online sessions (approximately half an hour each) delivered over three months. The sessions are designed by sports and psychology experts. Participants will receive tailored feedback based on their answers to short surveys that they complete at the beginning of each session. Study participants will receive email reminders to complete the sessions, followed by a phone call from a trial coordinator in case of low adherence to the procedures.
The study will compare the unique and additive effects of three forms of the tailored intervention on study outcomes based on different techniques from behavioural theory. One form will adopt techniques that focus on motivational processes; other one will add intentional self-regulatory processes while another will add the development of habits.
In the motivational condition participants will be asked questions about their main motives to be physically active. Based on their responses, they will receive feedback including BCTs that boost their motivation and help them specify and reach their goals. In the self-regulatory condition additional techniques supporting self-monitoring and regulation will be added, e.g. feedback on performance and progress throughout the intervention. In the habit formation condition participants will receive all aforementioned intervention components as well as techniques relevant to habit development, e.g. emphasising need to repeat the same activity in the same context, and establishing routines.
Participants will see relevant feedback on the computer screen once they have answered short surveys. For instance when they are asked about main barriers to be physically active, they will receive advice on how to overcome the barriers that they have selected. Participants self-reported physical activity will be measured at the beginning of each fortnightly survey and the feedback will be also tailored accordingly to the changes in physical activity.
Intervention code [1] 293358 0
Behaviour
Intervention code [2] 293359 0
Lifestyle
Intervention code [3] 293360 0
Prevention
Comparator / control treatment
Participants assigned to the control condition will be provided with information about physical activity recommendations and a library of short information materials relevant to the physical activity with the star rating system. It will be a static and non-personalised website; as previous research has reported these as ineffective in increasing physical activity.
Control group
Active

Outcomes
Primary outcome [1] 296751 0
The primary outcome assessed in this study will be physical activity measured using accelerometers (GENEActiv http://www.geneactiv.org/) worn on upper arm, for a week at each time point.
Timepoint [1] 296751 0
The primary outcome will be assessed at baseline before the intervention and at 3 months - post-intervention.
Secondary outcome [1] 319254 0
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ) short version
Timepoint [1] 319254 0
Assessed at baseline, and then at 3 months.
Secondary outcome [2] 319255 0
Sleep will be measured using the Pittsburgh Sleep Quality Index.
Timepoint [2] 319255 0
Assessed at baseline, and then at 3 months.
Secondary outcome [3] 319256 0
Theory-derived correlates of physical activity (composites of secondary outcome) will be assessed using items from various relevant questionnaires designed for this study assessing motivation, attitudes towards regular physical activity, outcome expectations, perceived behavioural control, subjective norms, intentions, barriers self-efficacy, action planning and coping planning, self-efficacy, goal facilitation and goal conflict.
Timepoint [3] 319256 0
Assessed at baseline, and then at 3 months.
Secondary outcome [4] 319257 0
Habit development will be measured with the Self-report Behavioural Automaticity Index.
Timepoint [4] 319257 0
Assessed at baseline, and then at 3 months.
Secondary outcome [5] 319258 0
How routinely people perform their behaviours will be measured with the Personal Need for Structure Scale.
Timepoint [5] 319258 0
Assessed at baseline, and then at 3 months.
Secondary outcome [6] 319259 0
Physical activity intentions will be measured with the Physical Activity Intentions three items scale
Timepoint [6] 319259 0
Assessed at baseline, and then at 3 months.
Secondary outcome [7] 319260 0
Depression, anxiety and stress will be assessed with the Depression, Anxiety and Stress Scale (DASS21).
Timepoint [7] 319260 0
Assessed at baseline, and then at 3 months.
Secondary outcome [8] 319261 0
Quality of life will be assessed with the Short Form 12 (SF12) measure.
Timepoint [8] 319261 0
Assessed at baseline, and then at 3 months
Secondary outcome [9] 319262 0
Perceived environment will be assessed with the Physical Activity Neighbourhood Environment Survey (PANES).
Timepoint [9] 319262 0
Assessed at baseline.
Secondary outcome [10] 319263 0
Internet use and intervention accessibility (composites of secondary outcome) will be measured with items developed specifically for this study.
Timepoint [10] 319263 0
Assessed at 3 months (post intervention).
Secondary outcome [11] 319264 0
Demographics will be assessed by online questionnaire designed for this study. The measures taken will include age, sex, marital status, ethnicity, education, weight, height, house income, and postcode. Demographic measures will also include the number of hours and days worked per week, work level (e.g., clinical nurse manager, registered nurse, patient care assistant), salary brackets associated with each employment level, and type of work undertaken (e.g., shift-worker, non-shift worker, mix).
Timepoint [11] 319264 0
Assessed at baseline.
Secondary outcome [12] 319265 0
Each participant's website usage will be assessed using Google analytics.
Timepoint [12] 319265 0
Assessed throughout the study.
Secondary outcome [13] 319266 0
The acceptability of content will be assessed using a 5 point star rating system.

After each tailored session, participants will be able to rate the content and advice received using the star rating; they will also have an open comment box for any post-session qualitative feedback.
Timepoint [13] 319266 0
Six times throughout study duration; following each fortnightly intervention sessions
Secondary outcome [14] 319499 0
Work absenteeism will be measured objectively from the HR records.
Timepoint [14] 319499 0
Assessed for 6 months prior intervention and then 6 months post baseline.
Secondary outcome [15] 322321 0
Usefulness and satisfaction with the intervention (composites of secondary outcome) will be measured with the System Usability Scale.
Timepoint [15] 322321 0
Assessed at 3 months (post intervention).
Secondary outcome [16] 322322 0
Participants' confidence in their ability to use internet will be measured with internet self-efficacy scale.
Timepoint [16] 322322 0
Assessed at 3 months (post intervention).
Secondary outcome [17] 322323 0
Acceptability of the advice provided, intervention delivery and format (composites of secondary outcome) will be measured with items used in previous studies and adapted specifically for this study.
Timepoint [17] 322323 0
Assessed at 3 months (post intervention).
Secondary outcome [18] 322324 0
Sitting time will be assessed using the work-related IPAQ module from the long version
Timepoint [18] 322324 0
Assessed at baseline, and then at 3 months.
Secondary outcome [19] 322517 0
The overall usage of the study page will be assessed using Google analytics.
Timepoint [19] 322517 0
Assessed throughout the study.

Eligibility
Key inclusion criteria
Eligible participants will include hospital staff employed in Perth, Western Australia. Staff working in shift patterns and non-shift workers will be eligible to participate. No restrictions will be placed on the type of contract and number of hours worked. Eligible participants will include nurses, midwifes and patient assistants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who have a self-reported physical condition or any physical impairment preventing them from being physically active will be excluded from the study. They will be screened using an adapted version of the Physical Activity Readiness Questionnaire (PARQ). Staff who do not have a mobile phone that allows them to receive normal text messages, who do not have access to internet on their mobile phone, computer or tablet, who are already active (engaging in more than 150 minutes of high intensity physical activity per week outside of work), and who are currently participating in any other physical activity program (e.g. a structured weight loss program, regular meetings with personal trainer or coach) will be ineligible to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed and it will be done by computerised central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order generation: simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed sample size (168) follows guidelines for appropriate sample sizes for pilot trials. The statistical analysis will include multiple mediation analysis. The changes from baseline to follow-up for each participant in each condition will be analysed. Depending on the number of missing data points, appropriate statistical methods will be used to account for missing data. Data will be tested for linearity and normal distribution; correlation among participants from the same hospital ward will be controlled for.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/04/2016
Actual
Date of last participant enrolment
Anticipated
1/05/2017
Actual
Date of last data collection
Anticipated
1/08/2017
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4801 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [2] 4802 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [3] 7795 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [4] 7796 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 15728 0
6008 - Subiaco
Recruitment postcode(s) [2] 15729 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 292483 0
University
Name [1] 292483 0
Curtin University
Country [1] 292483 0
Australia
Funding source category [2] 293230 0
University
Name [2] 293230 0
Central Queensland University
Country [2] 293230 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Health Psychology & Behavioural Medicine Research Group, School of Psychology and Speech Pathology, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 291192 0
University
Name [1] 291192 0
Central Queensland University
Address [1] 291192 0
Physical Activity Research Group, School of Human Health and Social Sciences, Building 18, Bruce Highway, Rockhampton, QLD 4702, Australia.
Country [1] 291192 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293948 0
Hollywood Private Hospital Ethics Committee
Ethics committee address [1] 293948 0
Ethics committee country [1] 293948 0
Australia
Date submitted for ethics approval [1] 293948 0
11/11/2015
Approval date [1] 293948 0
22/01/2016
Ethics approval number [1] 293948 0
HPH443
Ethics committee name [2] 294012 0
Kings Edward Memorial Hospital, The Women and Newborn Health Service (WNHS) Ethics Committee
Ethics committee address [2] 294012 0
Ethics committee country [2] 294012 0
Australia
Date submitted for ethics approval [2] 294012 0
02/02/2015
Approval date [2] 294012 0
Ethics approval number [2] 294012 0
2016034EW
Ethics committee name [3] 294662 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [3] 294662 0
Ethics committee country [3] 294662 0
Australia
Date submitted for ethics approval [3] 294662 0
09/02/2016
Approval date [3] 294662 0
16/02/2016
Ethics approval number [3] 294662 0
HR20/2016

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

Contacts
Principal investigator
Name 61882 0
Dr Dominika Kwasnicka
Address 61882 0
Health Psychology & Behavioural Medicine Research Group, School of Psychology and Speech Pathology, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, Western Australia 6845
Country 61882 0
Australia
Phone 61882 0
+61892662559
Fax 61882 0
Email 61882 0
[email protected]
Contact person for public queries
Name 61883 0
Dominika Kwasnicka
Address 61883 0
Health Psychology & Behavioural Medicine Research Group, School of Psychology and Speech Pathology, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, Western Australia 6845
Country 61883 0
Australia
Phone 61883 0
+61892662559
Fax 61883 0
Email 61883 0
[email protected]
Contact person for scientific queries
Name 61884 0
Dominika Kwasnicka
Address 61884 0
Health Psychology & Behavioural Medicine Research Group, School of Psychology and Speech Pathology, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, Western Australia 6845
Country 61884 0
Australia
Phone 61884 0
+61892662559
Fax 61884 0
Email 61884 0
[email protected]

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