Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000173190
Ethics application status
Approved
Date submitted
30/01/2019
Date registered
6/02/2019
Date last updated
22/01/2020
Date data sharing statement initially provided
6/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Virgin PulsE Global ChAllenge Study (VEGAS): A Single-Blind, Randomised Controlled Trial to Evaluate the Health Outcomes of the Virgin Pulse Global Challenge (VPGC) Programme
Scientific title
The Virgin PulsE Global ChAllenge Study (VEGAS): A Single-Blind, Randomised Controlled Trial to Evaluate the Health Outcomes of the Virgin Pulse Global Challenge (VPGC) Programme on quality of life among healthy employees
Secondary ID [1] 297238 0
None
Universal Trial Number (UTN)
U1111-1227-6070
Trial acronym
The Virgin PulsE Global ChAllenge Study (VEGAS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of life 311302 0
Depression 311303 0
Quality of sleep 311304 0
Hypertension 311306 0
Anxiety 311342 0
Condition category
Condition code
Mental Health 309933 309933 0 0
Depression
Public Health 309936 309936 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There is only one intervention group in this study. The intervention is the Virgin Pulse Global Challenge (VPGC) programme, which is a 100-day wellbeing solution that equips participants with the knowledge, tools and support required to improve lifestyle behaviour. The VPGC is a holistic health and wellbeing platform for participants, accessible 24/7, 365 days a year. All participants are encouraged to achieve 10,000 steps daily, but this is not mandatory.

Participants will be randomised into teams of seven either joining the intervention or control group. As soon as the teams are finalised, all participants will receive same activity step count tracker, they are then required to setup a login account either on the Virgin Pulse website [https://www.virginpulse.com] or via Virgin Pulse application (app) available at Google Store [https://play.google.com/store/apps/details?id=com.gettheworldmoving.hundreddaysevent&hl=en]. Next, participants are asked to sync their tracker with Virgin Pulse app to enable the daily steps to be recorded automatically throughout the 100-day. All activities involving step counts are automatically recorded on tracker, options are available to find the equivalent steps for activities such as swimming and cycling. The 100-day VPGC programme is developed by Virgin Pulse, the entire programme is delivered digitally on devices such as personal computer (through Virgin Pulse website) and Virgin Pulse app. Also, Virgin Pulse has an inbuilt daily email reminder system to remind participants to sync their daily steps. All data captured in Virgin Pulse website or on Virgin Pulse app are stored on Virgin Pulse server in Australia.

In addition to the step counts that participants need to sync with Virgin Pulse app, participants are also invited to complete a battery of online questionnaire using Qualtrics platform hosted in Swinburne University of Technology, and also have their blood pressure measurements taken by a student investigator. Student investigator is responsible in entering all blood pressure data into Qualtrics platform. The online questionnaire and blood pressure measurement will take approximately 60 minutes to complete.

A total of 30 organisations based in Victoria, Australia will be recruited by Virgin Pulse. Ideally, only people working in the office should be included as it will be difficult to assess employees who are constantly working in the field. It is the responsibility of Virgin Pulse to ensure that at least 14 participants from each organisation have consented to participate in the VPGC study. The 14 participants will be allowed to choose one of the two study teams, where the team members will work together throughout the 100-day VPGC programme. A simple randomisation (tossing a coin) will be performed within each organisation to determine which team will be allocated to intervention or control arm. The intervention team will be told not to discuss the VPGC programme with the control group for the duration of the study to minimise contamination.

Following is the overview of procedures for this study for both intervention and control groups:
6 weeks prior to VPGC programme
Step 1: N = 420. A student investigator will screen subject for eligibility, obtain informed consent, and to request subjects to obtain blood panel results from their General Practitioner.
Step 2: Randomisation will be conducted by a site coordinator. A minimum of 14 participants are required from each organisation.
VPGC Intervention Arm (N210, 30 teams)
Control Arm (N=210 (30 teams)

Visit 1 (Baseline Assessment)
At about 2-3 Weeks Prior to VPGC programme (expected to comment in April 2019 / August 2019), all participants are expected to complete the case report form that includes the following components. A quiet room located in the respective organisation will be sourced and make available for participants to complete the required information.
- Subject Demographics
- Social Activity
- Medical History
- Cognitive Assessment (CogState)
- Emotional Assessment (DASS-21)
- Quality of Life Assessment (PWI-A)
- Sleep Assessment (PSQI & ESS)
- Blood Pressure Measurement
Height, Weight, Hip & Waist Circumference, Body Fat Measurement

May 2019 / September 2019: Commencement of the 100-Day VPGC programme. After the programme ended, subjects in control arms will join the next VPGC programme in September 2019 and May 2020, respectively

Visit 2 (Within 2 weeks Immediately after VPGC programme)
This visit is expected to happen in September 2019/ January 2020. All participants are expected to complete the case report form that includes the following components. A quiet room located in the respective organisation will be sourced and make available for participants to complete the required information.
- Social Activity
- Medical History
- Cognitive Assessment (CogState)
- Emotional Assessment (DASS-21)
- Quality of Life Assessment (PWI-A)
- Sleep Assessment (PSQI & ESS)
- Programme Participation Satisfaction Survey
- Blood Pressure Measurement
Height, Weight, Hip & Waist Circumference, Body Fat Measurement

Visit 3 (3 Months Post VPGC programme)
This visit is expected to happen in January 2020 / April 2020. All participants are expected to complete the case report form that includes the following components. A quiet room located in the respective organisation will be sourced and make available for participants to complete the required information.
- Social Activity
- Medical History
- Cognitive Assessment (CogState)
- Emotional Assessment (DASS-21)
- Quality of Life Assessment (PWI-A)
- Sleep Assessment (PSQI & ESS)
- Blood Pressure Measurement
Height, Weight, Hip & Waist Circumference, Body Fat Measurement
Intervention code [1] 313490 0
Lifestyle
Intervention code [2] 313527 0
Behaviour
Comparator / control treatment
Participants will be randomised into teams of seven either joining the intervention or control group. All participants will receive same activity step count tracker. Participants from the control group will have no form of intervention except a facility to sync/enter daily step counts. Specifically, participants from the control group will be wait-listed to join the next cycle of VPGC programme (4 weeks after the end of the previous cycle).
Control group
Active

Outcomes
Primary outcome [1] 318857 0
Changes in Quality of life from baseline to within 20 days after VPGC programme completion as well as from baseline to 3 months post VPGC programme completion. The quality of life assessment will be conducted using the Personal Wellbeing Index-Adult version (PWI-A).
Timepoint [1] 318857 0
Baseline, within 20 days after VPGC programme completion and 3 months post VPGC programme completion.
Secondary outcome [1] 366270 0
The change in depression anxiety stress scale (DASS-21) score (emotional symptoms) from baseline to within 20 days after VPGC programme completion as well as from baseline to 3 months post VPGC programme completion.
Timepoint [1] 366270 0
Baseline, within 20 days after VPGC programme completion and 3 months post VPGC programme completion.
Secondary outcome [2] 366271 0
The change in global score in Pittsburgh Sleep Quality Index (PSQI) (measure of overall sleep dysfunction) from baseline to within 20 days after VPGC programme completion as well as from baseline to 3 months post VPGC programme completion.
Timepoint [2] 366271 0
Baseline, within 20 days after VPGC programme completion and 3 months post VPGC programme completion.
Secondary outcome [3] 366272 0
The change in Epworth Sleepiness Scale (ESS) score (daytime sleepiness) from baseline to within 20 days after VPGC programme completion as well as from baseline to 3 months post VPGC programme completion.
Timepoint [3] 366272 0
Baseline, within 20 days after VPGC programme completion and 3 months post VPGC programme completion.
Secondary outcome [4] 366273 0
The change in cognitive abilities from baseline to within 20 days after VPGC programme completion as well as from baseline to 3 months post VPGC program completion. A selective computerised cognitive assessment using CogState will be performed by the participants. It is designed and validated for clinical trials. Each of the CogState tests (see below) is designed to measure a specific area of cognition:
• Identification Test (Attention and reaction time test)
• Set-Shifting Test (Executive function)
• Two Back Test (Working memory)
Timepoint [4] 366273 0
Baseline, within 20 days after VPGC programme completion and 3 months post VPGC programme completion.
Secondary outcome [5] 366274 0
The change in blood pressure from baseline to within 20 days after VPGC programme completion as well as from baseline to 3 months post VPGC programme completion. Blood pressure measurement will be done using the OMRON HEM-907 model.
Timepoint [5] 366274 0
Baseline, within 20 days after VPGC programme completion and 3 months post VPGC programme completion.

Eligibility
Key inclusion criteria
1. Provision of signed and dated informed consent form.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Male or female, aged 18 and over.

4. In good general health as evidenced by self-reported the medical history.

5. Participants must be employed by Australian organisations agreed to participate in the VPGC programme.

6. Physically able to participate in the VPGC programme e.g. able to perform step-count.

7. Agreement to adhere to Lifestyle Consideration (stated below) throughout study duration.
• Not discuss the VPGC programme with the team assigned to the control arm for the duration of the study and vice versa .
• Fasted before any blood tests, collected by the participants’ respective physicians or pathologists.
• Abstain from caffeine, alcohol or strenuous exercise 4-6 hours before each study visit assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participants who have previously enrolled in the VPGC programme.

2. Pregnant women or women who plan to conceive during the VPGC programme.

3. Participants whose weigh more or equal to 150kg or more at baseline screening.

4. Participants who are unable to follow the VPGC programme due to physical limitations.

5. Participants who are unable to follow the VPGC programme due to language barriers.

6. Participants who are unable to commit to the study procedures and visits throughout the study duration.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Student investigator will screen all participants to ensure they fulfil the inclusion criteria. A site coordinator will be responsible in randomly assigning the participants into teams of seven in the intervention or control group. The randomisation is done according to the central randomisation by computer. Student investigator has no knowledge which group the participants is allocated to, information about randomisation is recorded and kept by the site coordinator only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order for the allocation of participants into different groups was based on a randomisation table created by computer software such as Stata version 14.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation is based on the primary endpoint defined as the change in quality of life score from baseline to 4th month. Previous study revealed on average, well-being improved immediately after the health program (+3.5 units of WHO-5) [1]. Assuming an average change in well-being of 3 units and standard deviation of 10 units from 4th month from baseline between intervention and control groups. With 80% power, 5% level of significance and 20% attrition, a total of 420 participants are needed for this study (210 participants in the control group and 210 participants in the intervention group).

All continuous data will be summarised using mean and standard deviation (SD), whilst frequency and percentage will be used to summarise categorical data.

Repeated Measures Mixed Models (RMMM) will be used to analyse the data and provide comparisons of the intervention group with the control group for all health assessments. Regression analyses will be conducted in order to establish the impact of physical activity, sleep, mental health and nutrition on heart age, using the module engagement data logged on the Virgin Pulse website. All analyses will be adjusted for covariates such as age and gender, as well as variables that differ significantly between two groups at baseline.

Missing data will be checked and explained in individual data tables. In the presence of outlier(s), appropriate justifications will be provided to explain the exclusion of the outlier(s) in statistical analyses.

A p-value < 0.05 will be used to determine statistical significance. Analyses will be performed using Stata version 11 (Stata Corporation, TX).

Reference:
1. Freak-Poli RLA, et al. Change in well-being amongst participants in a four-month pedometer-based workplace health program. BMC Public Health. 2014;14:953.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
22/05/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301795 0
University
Name [1] 301795 0
Swinburne University of Technology
Country [1] 301795 0
Australia
Funding source category [2] 301801 0
Commercial sector/Industry
Name [2] 301801 0
Gettheworldmoving Limited Trading as Virgin Pulse
Country [2] 301801 0
United Kingdom
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John Street, Hawthorn, VIC, 3122, Australia,
Country
Australia
Secondary sponsor category [1] 301541 0
Commercial sector/Industry
Name [1] 301541 0
Gettheworldmoving Limited Trading as Virgin Pulse
Address [1] 301541 0
Mortec Park, York Road Leeds, West Yorkshire, LS15 4TA, United Kingdom
Country [1] 301541 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302504 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 302504 0
Ethics committee country [1] 302504 0
Australia
Date submitted for ethics approval [1] 302504 0
01/02/2019
Approval date [1] 302504 0
03/05/2019
Ethics approval number [1] 302504 0
SHR Project 2019/035

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

Contacts
Principal investigator
Name 90442 0
Dr Won Sun Chen
Address 90442 0
Swinburne University of Technology, Department of Statistics, Data Science and Epidemiology, Level 9. Internal Mail H24, P.O.Box 218, Hawthorn, VIC, 3122, Australia
Country 90442 0
Australia
Phone 90442 0
+61 3 9214 8437
Fax 90442 0
Email 90442 0
[email protected]
Contact person for public queries
Name 90443 0
Won Sun Chen
Address 90443 0
Swinburne University of Technology, Department of Statistics, Data Science and Epidemiology, Level 9. Internal Mail H24, P.O.Box 218, Hawthorn, VIC, 3122, Australia
Country 90443 0
Australia
Phone 90443 0
+61 3 9214 8437
Fax 90443 0
Email 90443 0
[email protected]
Contact person for scientific queries
Name 90444 0
Won Sun Chen
Address 90444 0
Swinburne University of Technology, Department of Statistics, Data Science and Epidemiology, Level 9. Internal Mail H24, P.O.Box 218, Hawthorn, VIC, 3122, Australia
Country 90444 0
Australia
Phone 90444 0
+61 3 9214 8437
Fax 90444 0
Email 90444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data collected from this study will not be shared because it is owned by Virgin Pulse, not the research team.


What supporting documents are/will be available?




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.