None listed
Conditions
Brief summary
This study aims to conduct a single-blind randomised controlled trial to evaluate health outcomes of the Virgin Pulse Global Challenge (VPGC) programme across several Australian organisations. A comparison of the VPGC programme with a control treatment in terms of physical activity, sleep, psychological well-being, cognition and overall health outcomes will be assessed. It is hypothesised that the VPGC will improve both physical and mental health of participants. The project will contribute to filling a gap in the literature (rigorous evaluation of the health benefits of programmes similar to the VPGC and the development of a heart age measure that quickly responds to behavioural change) while providing Virgin Pulse with tools, insights, models and recommendations for improving the Global Challenge programme.
Interventions
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
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
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed