Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001785291
Ethics application status
Approved
Date submitted
29/10/2018
Date registered
31/10/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
31/10/2018
Date results provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot-RCT of an app-based intervention to reduce the cardiovascular disease risk in shift-workers through targeting multiple lifestyle behaviours.
Scientific title
A pilot-RCT of an app-based intervention to reduce the cardiovascular disease risk in shift-workers through targeting multiple lifestyle behaviours.
Secondary ID [1] 296443 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 310208 0
lower quality diet 310212 0
inadequate sleep 310213 0
Condition category
Condition code
Public Health 308951 308951 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Move, Eat & Sleep Shift-worker study is a pilot study that uses a randomised controlled trial (RCT) with two parallel groups involving an Intervention group, and a wait-list control group.
The primary aim of the proposed pilot- randomised controlled trial is to evaluate the feasibility of the study protocol and the acceptability and appropriateness of the shift-worker tailored intervention in a 4-week trial in adult shift-workers. The secondary aim is to assess the preliminary efficacy of the intervention by comparing changes in physical activity levels, diet quality and sleep quality in the Intervention (n=20) and education only control (n=20) groups.
Participants will receive access to the specifically designed app (Balanced). Educational materials as part of the app will include educational materials on physical activity, dietary and sleep duration guidelines, information on the physical, mental and social benefits of increasing physical activity, and improving diet and sleep quality. SMART goal setting techniques, overcoming barriers, how to create action plans, an action planning tool, relaxation and stress management techniques provided via the app. Participants are also emailed an electronic version (pdf document) of these Educational Resources information in the form of a participant ‘handbook’. These resources have been developed based on existing resources (i.e. doi:10.1136/bmjopen-2017-018997; https://doi.org/10.1016/j.cct.2018.08.007 ; ACTRN12617000735358) and adapted to the shiftworker population. These modifications included suggestions on the timing of sleep (including naps) to adapt to changing shift schedules and promote recovery between shifts, timing of physical activity and meals to align with shift schedules.

The participant handbook includes an overview of the key app features and functionality and a brief “how to guide” for participants which includes both graphical (from the app) and text based examples. No in person introduction is provided to the app.

Participants will be asked to use the Balanced app daily for self-monitoring of behaviours but are instructed they can use the app as much or as little as they like and they will have access to the app continuously throughout the entire study period.
Participants will be able to self-monitor daily physical activity (minutes of MVPA, sessions of resistance training, daily steps (if they have a step counting device), improved diet quality (number of serves of core foods, soft-drink/fast food free days) and improved sleep (duration, quality, hygiene and variability [time to bed and awake]) and update these goals in line with their progress. Personalised feedback on progress towards goals will be provided using graphs on a daily, weekly and monthly basis. Additional weekly summaries with more detailed feedback (e.g. most active days, # of days where goals were achieved) will be emailed to participants. Participants will receive automated self-monitoring SMS/e-mail reminders. Secondary outcomes will be assessed using an online survey.
Participants will be sent weekly SMS to provide educational and motivating ‘facts’ about how target behaviours (physical activity, diet and sleep (if in enhanced group) can influence health. Weekly SMS will also be sent to prompt reengagement with self monitoring if self monitoring has stopped (defined as no self monitoring on 4 days out of 7). Intervention group participants will receive an email that provides a weekly summary of their self-monitored behaviours and progress against goals. This is intended to build self-efficacy for changing behaviours.
Feedback will be provided to participants on behaviour and weight via in-app feedback, emailed personalised weekly summaries, and for dietary behaviours only, additional in person, and online feedback via completion of the Healthy Eating Quiz (www.healthyeatingquiz.com.au).
Adherence to the intervention will be assessed by monitoring the usage of the intervention app provided to self monitor behaviours. This provides information on date and time a self monitoring entry is made and also the details of the actual entry (eg. 30 minutes of activity).
Intervention code [1] 312769 0
Lifestyle
Comparator / control treatment
The wait-list control group will complete assessments but will receive no intervention materials during the month study period and will be asked to maintain current sleep, activity and dietary behaviours. They will be provided with access to the intervention after the completion of the week 4 assessment
Control group
Active

Outcomes
Primary outcome [1] 307915 0
Study protocol suitability:
a) Weekly recruitment rates and characteristics of study participants
b) Using the SPIRIT table (Standard Protocol Items: Recommendations for Interventional trials), track potential participants who meet eligibility criteria, consenting participants who complete baseline assessment, participants who commence their randomly allocated treatment (i.e. download the app and access the materials) and participants who complete all follow up assessments.
c) Assess the capacity and resources needed to complete all study processes. These outcomes are determined based on project management documents and participant tracking database including daily time taken to respond to participant queries via email/phone, sending participant reminders, and determining eligibility for inclusion to the study.
Timepoint [1] 307915 0
4 weeks
Primary outcome [2] 307916 0
Implementation outcomes of:
a. User engagement/ adoption: user engagement with the intervention platform will be continuously assessed by actual self-monitoring data entered and the date/time of each entry and time to non-usage attrition.
b. Acceptability: intervention usability and satisfaction will be assessed using established instruments (e.g., System Usability Scale) as in the feasibility study.
c. Semi-structured phone interviews: participants will be asked a series of questions in relation to motivations for enrolling and intervention expectations, perceived acceptability and appropriateness of the intervention, what elements they found beneficial and what elements they think are in need of improvement. Recordings will be transcribed and analysed for themes.
Timepoint [2] 307916 0
4 weeks
Secondary outcome [1] 353321 0
Weekly minutes of moderate to vigorous intensity physical activity measured using the Active Australia Questionnaire
Timepoint [1] 353321 0
Assessed at baseline and 4 weeks
Secondary outcome [2] 353322 0
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 353322 0
Assessed at baseline and 4 weeks
Secondary outcome [3] 353323 0
Dietary intake and diet quality, Measured using the Healthy Eating Quiz (a component within the Australian Eating Survey)
Timepoint [3] 353323 0
Assessed at baseline and 4 weeks
Secondary outcome [4] 353324 0
Symptoms severity of depression, anxiety and stress assessed using the Depression, Anxiety and Stress Scale - 21 (DASS-21)
Timepoint [4] 353324 0
Baseline and 4 weeks
Secondary outcome [5] 353325 0
Health-related Quality of life measure using the SF-12
Timepoint [5] 353325 0
Baseline and 4 weeks
Secondary outcome [6] 353326 0
Sitting behaviour measured using the Workforce Sitting Questionnaire.
Timepoint [6] 353326 0
Baseline and 4 weeks
Secondary outcome [7] 353327 0
Sleep timing using the Sleep Timing Questionnaire
Timepoint [7] 353327 0
Baseline and 4 weeks
Secondary outcome [8] 353328 0
Assessment of the severity of insomnia using the Insomnia Severity Index
Timepoint [8] 353328 0
Baseline and 4 weeks
Secondary outcome [9] 353329 0
Assessment of the sleep apnea using the Berlin Questionnaire
Timepoint [9] 353329 0
Baseline and 4 weeks
Secondary outcome [10] 353330 0
App usage during the intervention period will be measured via the app database. For example this will include how many self-monitoring entries are made and the length of time the app is regularly interacted with during the intervention.
Timepoint [10] 353330 0
Continuously throughout the study period
Secondary outcome [11] 353331 0
Eating competence measured using the ecSatter Inventory 2.0
Timepoint [11] 353331 0
baseline and 4 weeks
Secondary outcome [12] 353332 0
Assessment of a participants’ predilection for morningness or eveningness using the reduced scale Morning/Evening Questionnaire
Timepoint [12] 353332 0
Baseline and 4 weeks
Secondary outcome [13] 353333 0
Self-reported frequency of resistance training (number of days) in the last week that resistance training was performed using the method described in https://doi.org/10.1016/j.cct.2018.08.007
Timepoint [13] 353333 0
Baseline and 4 weeks
Secondary outcome [14] 353334 0
Sleep Hygiene measured with the Sleep Hygiene Index
Timepoint [14] 353334 0
Baseline and 4 weeks
Secondary outcome [15] 353422 0
Self-reported duration of resistance training (minutes) in the last week that resistance training was performed using the method described in https://doi.org/10.1016/j.cct.2018.08.007
Timepoint [15] 353422 0
baseline and 4 weeks

Eligibility
Key inclusion criteria
- Shift worker
- And one or more of these criteria:
Rate sleep as bad or fairly bad, OR
Diet quality screening questionnaire score of <=6 , OR
Insufficiently active: activity time <150 min
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded if not reporting at least one of the following behaviours
1. Rate sleep as bad or fairly bad,
2. Diet quality screening questionnaire score of <=6 ,
3. Insufficiently active: activity time <150 min.


Other exclusion criteria are:
- Not residing in Australia
- Not having access to an internet- enabled iOS (Apple) or Android smartphone or tablet
- Not being between 18 and 65 years old;
- Reporting a height and weight that is not consistent with a BMI between 18.5 and 40;
- Currently pregnant or having given birth in the past 12 months;
- Having a condition that would make it unsafe or limits their ability to increase activity levels, change their diet or change sleep behaviours;
- Currently consuming hypnotics (sleep inducing medication);

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 sequence will be concealed by the use of sequentially numbered, opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was generated using Stata v15.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to the nature of the study and the primary aims descriptive analyses will be used to assess the primary outcomes. Secondary outcomes will be examined using Mixed Models comparing changes within and between groups and their interaction.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2018
Actual
2/11/2018
Date of last participant enrolment
Anticipated
Actual
6/11/2018
Date of last data collection
Anticipated
31/01/2019
Actual
14/12/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301040 0
University
Name [1] 301040 0
University of Newcastle
Country [1] 301040 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle, University Drive, Callaghan, NSW, 2308, Australia
Country
Australia
Secondary sponsor category [1] 300637 0
None
Name [1] 300637 0
Address [1] 300637 0
Country [1] 300637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301795 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 301795 0
Research Services
Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 301795 0
Australia
Date submitted for ethics approval [1] 301795 0
10/08/2018
Approval date [1] 301795 0
15/10/2018
Ethics approval number [1] 301795 0
H-2017-0039

Summary
Brief summary
There is relatively little information available regarding how to tailor remotely delivered lifestyle behaviour change interventions to the unique needs of shift-workers.
The primary aims of the proposed project is to assess the feasibility of the study protocol of the proposed shift-worker tailored intervention utilising an app-based intervention to target multiple health behaviours by conducting a parallel 2-arm pilot-RCT, and evaluate the implementation outcomes. The intervention is a modified version of an existing intervention that targets physical activity, dietary and sleep behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88130 0
A/Prof Mitch Duncan
Address 88130 0
ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country 88130 0
Australia
Phone 88130 0
+61 2 49217805
Fax 88130 0
Email 88130 0
mitch.duncan@newcastle.edu.au
Contact person for public queries
Name 88131 0
Mitch Duncan
Address 88131 0
ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country 88131 0
Australia
Phone 88131 0
+61 2 49217805
Fax 88131 0
Email 88131 0
mitch.duncan@newcastle.edu.au
Contact person for scientific queries
Name 88132 0
Mitch Duncan
Address 88132 0
ATC Building, Level 3, The University of Newcastle, University Drive, Callaghan NSW 2308
Country 88132 0
Australia
Phone 88132 0
+61 2 49217805
Fax 88132 0
Email 88132 0
mitch.duncan@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will require approval by the ethics committee


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.