Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001352796p
Ethics application status
Submitted, not yet approved
Date submitted
12/10/2022
Date registered
21/10/2022
Date last updated
21/10/2022
Date data sharing statement initially provided
21/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a wearable technology reliably measure stress levels?
Scientific title
Evaluating wearable technology to measure stress in healthy adults: The WEARABLE Study - Wristband hEArt Rate vAriaBiLity to measure strEss
Secondary ID [1] 308161 0
None
Universal Trial Number (UTN)
U1111-1283-7462
Trial acronym
WEARABLE
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Stress 327878 0
Depression 327879 0
Anxiety 327880 0
Condition category
Condition code
Mental Health 324967 324967 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary aim of this study is to explore whether heart rate variability (HRV) measured using the WHOOP wristband is a reliable measure of stress levels, compared to current measures (i.e., questionnaires).

Study visits and assessments
Participants who are eligible and consent to participate, will be invited to attend 2 face-to-face study visits over a period of 2-3 weeks. The first visit will be a group clinic visit and the second an individual clinic visit. Each visit will take approximately 60 minutes.

Group clinic visit (~10-12 participants) at Royal Perth Hospital (RPH) Research Foundation (RF), ~60 minutes:
1) Participants will be provided with a WHOOP wristband (free of charge)
2) Participants will be asked to download a WHOOP application on their phone.
3) Participants will be required to wear a WHOOP wristband for a minimum of 14 consecutive days (24/7).
4) Participants will be asked to measure their blood pressure twice a day (in the morning and in the evening), for 14 consecutive days, using a portable monitor (provided).
5) Participants will be required to complete online questionnaires at home at their convenience, one time during the study (one link includes 60 questions - estimated time for completion is 1 hour; one link for reporting medication use - estimated time for completion is 10 minutes).

Individual (final) study clinic visit (~60 minutes) at RPH RF:
An individual clinic visit will be scheduled within 2-3 weeks after the group clinic visit. This will be the second and final clinic visit, and the investigators will:
1) Measure participants body weight and height
2) Assess participants grip strength
3) Perform an electrocardiogram (ECG)
4) Collect a sample of hair which will be used to assess cortisol levels (stress hormone); this is optional
5) Provide a $30 gift card
Intervention code [1] 324605 0
Not applicable
Comparator / control treatment
Heart rate variability (HDR, a marker of stress) assessed by a WHOOP wristband, will be compared with other measures of stress (HRV from an electrocardiogram, stress index from current questionnaires and cortisol levels from hair samples).
Control group
Active

Outcomes
Primary outcome [1] 332766 0
The reliability of heart rate variability (a proposed marker of stress), assessed using a WHOOP device, in assessing stress when compared to the current gold-standard heart rate variability assessed from an electrocardiogram.
Timepoint [1] 332766 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using WHOOP device; HRV derived from an electrocardiogram assessed at the last clinic visit (individual visit).
Primary outcome [2] 332769 0
The reliability of heart rate variability (a proposed marker of stress), assessed using a WHOOP device, in assessing stress when compared to current stress index assessed from a validated questionnaire (PSQ, perceived stress questionnaire).
Timepoint [2] 332769 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using WHOOP device; stress index derived from a validated perceived stress questionnaire (PSQ) assessed once, before the end of the study (prior to the last, individual visit).
Primary outcome [3] 332771 0
The reliability of heart rate variability (a proposed marker of stress), assessed using a WHOOP device, in assessing stress when compared to cortisol levels (from hair samples), a biomarker of stress.
Timepoint [3] 332771 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using WHOOP device; cortisol levels (a biomarker of stress) assessed at the last clinic visit (individual visit).
Secondary outcome [1] 414938 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress, with stress, anxiety and depression using the Depression, Anxiety and Stress Scale (DASS-21).
Timepoint [1] 414938 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; DASS-21 will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [2] 414939 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress, with satisfaction with life (assessed using the Satisfaction with life scale).
Timepoint [2] 414939 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; Satisfaction with life scale will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [3] 414940 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress, with wellbeing assessed using the World Health Organisation-Five Well-Being Index (WHO-5).
Timepoint [3] 414940 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; WHO-5 will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [4] 414941 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress, with loneliness, social support, social isolation using the Loneliness, social isolation, and social support questionnaire.
Timepoint [4] 414941 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; Loneliness, social isolation, and social support questionnaire will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [5] 414942 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress, with mindfulness using the Mindful Attention Awareness Scale (MAAS).
Timepoint [5] 414942 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; MASS will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [6] 414943 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress, with sleep quality using the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [6] 414943 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; PSQI will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [7] 414944 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress with dietary intakes using a food frequency questionnaire (FFQ, from the Cancer Council of Victoria).
Timepoint [7] 414944 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; FFQ will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [8] 414945 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress with beverage intake using a Beverage questionnaire extensively used by our team.
Timepoint [8] 414945 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; The beverage questionnaire will be completed online once, before the end of the study (prior to the last, individual visit).
Secondary outcome [9] 414946 0
The association of a WHOOP-derived heart rate variability (a proposed marker of stress) in assessing stress with physical activity levels using the International Physical Activity Questionnaire (IPAQ)-short.
Timepoint [9] 414946 0
Heart rate variability assessed continuously for 14 days from group clinic visit (first visit) using a WHOOP device; IPAQ will be completed online once, before the end of the study (prior to the last, individual visit).

Eligibility
Key inclusion criteria
1) Male and female students aged over 18y
2) Have a smartphone
3) Comply with all study procedures
4) Be willing and able to provide a written informed consent and understand all pertinent aspects of the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Unable to attend study visits
2) Not be participating in any other research studies
3) Any other reason that the investigator deems the individual unsuitable to be enrolled (i.e., participant doesn’t seem to understand the information provided)

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Stress levels estimated using HRV derived from a WHOOP wrist strap will be compared with the data assessed using validated self-reported questionnaires, ECG, and hair cortisol to address the research question: Does HRV assessed using the WHOOP wristband correlate with levels of stress using validated questionnaires, ECG and hair cortisol? Secondary aims are to determine whether WHOOP outputs correlate with results obtained from self-reported questionnaires on other measures of mental health and well-being including anxiety and depression, satisfaction with life, loneliness, social support and social isolation, mindfulness, and sleep quality, as well as diet (particularly consumption of FV), physical activity and blood pressure.
Confounding factors will include age, sex, marital status, education, alcohol consumption, smoking, and physical activity levels. Subgroup analysis will include age, sex, physical activity levels, and BMI.
The estimated sample size for this study is 100 participants, and the estimated time to complete the study will be approximately 5 months (~10 participants every 2 weeks = estimated 20 weeks to reach 100 participants plus 4 weeks to account for drop offs; total time to complete the study = 6 months).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
11/08/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23360 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 38739 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 312422 0
Other
Name [1] 312422 0
Nutrition & Health Innovation Research Institute
Country [1] 312422 0
Australia
Primary sponsor type
Other
Name
Nutrition & Health Innovation Research Institute
Address
270 Joondalup Dr, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 313993 0
None
Name [1] 313993 0
Address [1] 313993 0
Country [1] 313993 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311764 0
ECU Human Research Ethics Committee (HREC)
Ethics committee address [1] 311764 0
270 Joondalup Dr, Joondalup WA 6027
Ethics committee country [1] 311764 0
Australia
Date submitted for ethics approval [1] 311764 0
23/08/2022
Approval date [1] 311764 0
Ethics approval number [1] 311764 0

Summary
Brief summary
Prolonged stress is known to cause mental and physical health problems such as depression, anxiety and cardiovascular disease (CVD). To date, there is not a gold standard measure of stress. Stress levels are subjectively assessed using questionnaires and having instruments that can evaluate stress levels more directly (i.e., through heart rate variability [HRV]) could help with the early detection of stress, and potentially prevent the onset of stress-related conditions. Wearable devices are popular and have the capacity to collect data continuously, in real-time, which may help monitor stress levels.

In the WEARABLE (Wristband hEArt Rate vAriaBiLity to measure strEss) study, we aim to examine whether a WHOOP®-derived HRV, a proposed marker of stress levels, can be a reliable and accurate measure of stress. We will investigate the associations of stress levels (HRV assessed by a wrist strap) with self-reported stress (commonly used questionnaires), HRV assessed using an electrocardiogram (ECG [gold-standard for measuring HRV]) and hair cortisol (biomarker of stress). The outcomes of this pilot study could provide evidence for the use of wrist wearable devices in future clinical trials investigating the role of stress on health outcomes. Additionally, this may encourage improvements with the inclusion of HRV measures in commercially available wrist wearable devices, so there is a broad range of devices that can be used to monitor stress levels in the wider population. Currently there is no gold standard for measuring stress levels. The best measures include self-reported instruments using questionnaires, salivary or hair cortisol and HRV assessed using ECG. Although ECG is the gold standard for measuring HRV, which is related to stress levels, it is unclear whether HRV could directly represent stress levels.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 122286 0
Dr Simone Radavelli Bagatini
Address 122286 0
Nutrition & Health Innovation Research Institute
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Dr, Joondalup WA 6027
Country 122286 0
Australia
Phone 122286 0
+61 0433487410
Fax 122286 0
Email 122286 0
[email protected]
Contact person for public queries
Name 122287 0
Dr Simone Radavelli Bagatini
Address 122287 0
Nutrition & Health Innovation Research Institute
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Dr, Joondalup WA 6027
Country 122287 0
Australia
Phone 122287 0
+61 0433487410
Fax 122287 0
Email 122287 0
[email protected]
Contact person for scientific queries
Name 122288 0
Dr Simone Radavelli Bagatini
Address 122288 0
Nutrition & Health Innovation Research Institute
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Dr, Joondalup WA 6027
Country 122288 0
Australia
Phone 122288 0
+61 0433487410
Fax 122288 0
Email 122288 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
NA


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.