Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001074987p
Ethics application status
Submitted, not yet approved
Date submitted
28/07/2020
Date registered
19/10/2020
Date last updated
19/10/2020
Date data sharing statement initially provided
19/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an exercise intervention on the sleep of sedentary Australian pregnant women
Scientific title
Effect of an exercise intervention on the sleep of sedentary Australian pregnant women
Secondary ID [1] 301898 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep quality during pregnancy 318403 0
Pregnancy 318404 0
Physical inactivity 318405 0
Sedentary behavior 318743 0
Condition category
Condition code
Mental Health 316417 316417 0 0
Studies of normal psychology, cognitive function and behaviour
Reproductive Health and Childbirth 316418 316418 0 0
Normal pregnancy
Physical Medicine / Rehabilitation 316759 316759 0 0
Other physical medicine / rehabilitation
Neurological 316760 316760 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design:
This study is an 11-week pre-post intervention feasibility study

Participants:
Participants will be comprised of approximately 30 Australian pregnant women who can speak and read English without assistance and are free of medical or obstetric contraindications. In order to take part in the study participants must not currently be reaching exercise levels in accordance with Australian exercise during pregnancy guidelines. Participant exercise levels will be determined using the Pregnancy Physical Activity Questionnaire (PPAQ). The PPAQ is a valid and reliable tool for measuring physical activity in adults aged 18 to 65 years. It can be self-administered by participants in an online format and requires them to recall physical activity over the previous 7 days. Participants will undergo a screening process to ensure they are free of medical or obstetric contraindications and can participate in exercise safely. Participants will be screened using the Physical Activity Readiness Medical Examination (PARMED-X) completed online. Once participants have passed the screening process, they will begin the study in their first or early second trimester of pregnancy (approximately 10-14 weeks gestation) to ensure completion in the second trimester for consistency.

Materials:
• Participant expression of interest and information form
• Consent and Whoop device care agreement form
• Whoop device and study instructions
• 15 or more wrist-worn Whoop devices
• Pittsburgh Sleep Quality Index (PSQI)
• Depression and Anxiety Stress Scale (DASS-21)
• Intervention website
• Funds for payment of Exercise Physiologist
• Paid Facebook advertisement for participant recruitment
• Unpaid advertising on Instagram and Twitter for participant recruitment

Procedure:
Participants will be recruited using online advertisement on social media websites Facebook, Instagram, and Twitter. will follow a link on an online advertisement to a website (www.healthymamas.org.au) where they will submit an ‘expression of interest’ to take part in the study and be provided with further information regarding the study procedure. Participants will create an account where they provide basic contact and demographic details, agree to an informed consent form and complete the PARMED-X screening for medical and obstetric contraindications as well as complete a short version of the PPAQ questionnaire to determine their eligibility to participate in the study. Once a participant has created an account and deemed eligible, they will be mailed a Whoop device along with return tracked postage. If they are not eligible to participate, they will be notified immediately via the website.
While waiting for their Whoop device to arrive in the mail, participants will engage in their initial consultation with the lead researcher over the phone or by skype/Zoom to discuss the baseline data collection requirements. Following the baseline data collection stage, participants will meet with the lead researcher again to discuss the intervention aspect of the study in detail. This will also be an opportunity for participants to discuss potential barriers to compliance and put in place a plan to succeed in increasing their exercise levels. See below an in-depth overview of the intervention:

Intervention timeline:

Participant screening:
Participants will complete a short eligibility questionnaire to assess their eligibility to participate in the study. Participants will be screened for eligibility based on the following criteria:
• They must be able to begin the intervention on or before their 14th week of pregnancy
• They must be considered ‘sedentary’, thus not be meeting the recommended amount of exercise per week.
• They must be free of medical and obstetric contraindications as determined by the PARMED-X.

Pre-intervention (2 weeks):

Pre-week 1
Pre-week 1 will consist of 7 days of baseline data collection. Participants will be asked to wear the Whoop device on their non-dominant wrist and continue with their daily lives as normal.

Pre-week 2
Participants will speak with the lead researcher about what is required from them during the study. The lead researcher will explain the intervention in greater detail and will discuss participants motivations/barriers to exercise and put in place a behaviour change plan to assist participants in adhering to the intervention.

Intervention (8 weeks):
Participants will be asked to gradually increase their exercise levels from 50 minutes of moderate to vigorous physical activity (MVPA) total per week to 150 minutes of MVPA total per week in accordance with recommended guidelines. Once participants are meeting the 150 minutes of exercise per week they will continue exercising at that level until the completion of the intervention. Participants will engage in both aerobic and resistance-based exercises in accordance with exercise during pregnancy guidelines. The resistance-based exercise plan will be designed by exercise physiologist who is experienced in pregnancy health. The exercise plan will utilise pre-recorded and narrated videos already developed for use in another pregnancy exercise intervention (Fit4Two) also designed by pregnancy exercise experts. Participants will engage in the exercise intervention from the comfort of their own homes.
The goal of the exercise intervention is to increase pregnant women’s participation in exercise to levels in accordance with recommended guidelines in order to improve sleep. Research indicates that any exercise is more beneficial to sleep than none during pregnancy, and several different forms of exercise, such as yoga and swimming have been found to improve sleep during pregnancy. Thus, it is posited that providing participants engage in exercise in accordance with guidelines (150 – 300 minutes of moderate intensity aerobic exercise such as walking, jogging, cycling, and two resistance-based workouts per week) good sleep should occur.
Participants will be instructed to slowly build their weekly physical activity levels during the first 5 weeks of the study from 50 minutes of MVPA to 150 minutes of MVPA in accordance with Sports Medicine Australia (SMA) and American College of Obstetrics and Gynaecology (ACOG) exercise during pregnancy guidelines. For example, should participants choose to exercise on 5 days of the week, they will only be increasing their exercise time by 5 minutes per day compared to the previous week. It is important to slowly increase participants fitness levels as participants are classified as sedentary and therefore not meeting recommended levels of exercise at the time of beginning the intervention. Slowly increasing fitness levels will be more pleasant and achievable for participants and will result in less physical strain. Participants adherence to the exercise intervention will be monitored by researchers on a weekly basis by assessing the data measured by the Whoop device.

Follow up (1 week):
Follow up week (the final week of the data collection) will consist of 7 days of post intervention data collection. Participants will be asked to wear the device and continue with their daily lives as normal. They will not be instructed to participate in any exercise.

Measures:
The Whoop device (WHOOP Inc, Boston, MA, USA) is a commercially available wearable device that has been third-party validated to accurately measure sleep, resting heart rate, heart rate variability, and respiratory rate (Berryhill et al., 2020). In conjunction with an associated smartphone application and cloud-based computing platform, the Whoop collects 24/7 heart rate, 3-axis accelerometer, temperature, and 3-axis gyroscope data which, among other things, it uses to identify and classify workouts, activities, and sleep.

The PSQI and DASS-21 will be completed by participants at three time points (pre-intervention, during the intervention, and during follow-up). The PSQI is a validated measure for collecting sleep data among pregnant women 23. Data obtained from the PSQI will add to that collected by the Whoop device and will provide an even more in-depth overview of the sleep of participants across the 10 week intervention period. The DASS-21 will be completed by participants in order to control for depression, anxiety and stresses that may be experienced by participants across the study period. If participants are found to be experiencing distress above what is considered normal, they will be contacted and provided with advice to visit their GP or contact their current health provider as well as contact information for counselling services and psychological support organisations including Lifeline Australia and Beyond Blue. Additionally, the Australian Government's Pregnancy Birth and Baby hotline contact details will also be provided for pregnancy specific advice.
Intervention code [1] 318185 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324571 0
Total sleep time as measured by a Whoop device (the Whoop device uses Photoplethysmography (PPG) and a three-axis accelerometer to measure sleep, heart rate and physical activity behaviours)
Timepoint [1] 324571 0
Assessed daily from baseline for 11 weeks
Primary outcome [2] 324572 0
Sleep efficiency as measured by a Whoop device
Timepoint [2] 324572 0
Assessed daily from baseline for 11 weeks
Primary outcome [3] 324573 0
Wake after sleep onset as measured by a Whoop device
Timepoint [3] 324573 0
Assessed daily from baseline for 11 weeks
Secondary outcome [1] 385003 0
Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 385003 0
Assessed at baseline, during week 6 of the intervention, and one week post intervention.
Secondary outcome [2] 386091 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 386091 0
Assessed at baseline, during week 6 of the intervention, and one week post intervention.

Eligibility
Key inclusion criteria
Participants must be able to begin the intervention on or before their 14th week of pregnancy and be considered ‘sedentary’, thus not be meeting the recommended amount of exercise per week.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they are deemed to have a medical and/or obstetric contraindication to exercise as determined by the PARMED-X.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 384 participants is required to answer the research questions with a 95% confidence interval (CI) in order to be representative of Australian pregnant women. This calculation is based on the fact that 309,142 women were pregnant and gave birth in Australia in 2017 (Australian Bureau of Statistics, 2018). As this is a feasibility study and due to budget and equipment availability a sample size of approximately 30 participants will be sought.

Data generated from the Whoop devices will be exported as an Excel spreadsheet and uploaded to IBM SPSS Statistics 24 for data cleaning and analysis. Descriptive statistics including percentages, means, standard deviations and frequencies will be calculated using SPSS. Differences among groups (e.g. total sleep time pre and post intervention) will be tested using t-test’s for independent samples. Chi-square analysis will be conducted to determine relationships between demographic characteristics and categorical variables (e.g. to ascertain whether a relationship exists between age and poor sleep). Repeated-measure analysis of variance (ANOVA) or mixed-models with random effects will be used to measure main outcomes depending on which analysis method is most appropriate for the data collected. Significance levels will be set at p = 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
25/06/2021
Actual
Date of last data collection
Anticipated
25/09/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306315 0
University
Name [1] 306315 0
Central Queensland University
Country [1] 306315 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Central Queensland University, 554-700 Yaamba Rd, Norman Gardens QLD 4701
Country
Australia
Secondary sponsor category [1] 306809 0
Individual
Name [1] 306809 0
Dr Melanie Hayman
Address [1] 306809 0
Central Queensland University, 554-700 Yaamba Rd, Norman Gardens QLD 4701
Country [1] 306809 0
Australia
Secondary sponsor category [2] 306810 0
Individual
Name [2] 306810 0
Dr Michele Lastella
Address [2] 306810 0
Central Queensland University, 44 B26, Wayville SA 5034
Country [2] 306810 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306528 0
Central Queensland University Ethics Committee
Ethics committee address [1] 306528 0
554-700 Yaamba Rd, Norman Gardens QLD 4701
Ethics committee country [1] 306528 0
Australia
Date submitted for ethics approval [1] 306528 0
16/06/2020
Approval date [1] 306528 0
Ethics approval number [1] 306528 0

Summary
Brief summary
The present project is a feasibility study which aims to examine the effect of an 11-­week exercise intervention on the sleep of sedentary Australian pregnant women.
Trial website
www.healthymamas.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104170 0
Mrs Summer Cannon
Address 104170 0
Central Queensland University, 554-700 Yaamba Rd, Norman Gardens QLD 4701
Country 104170 0
Australia
Phone 104170 0
+61 0409875494
Fax 104170 0
Email 104170 0
[email protected]
Contact person for public queries
Name 104171 0
Mrs Summer Cannon
Address 104171 0
Central Queensland University, 554-700 Yaamba Rd, Norman Gardens QLD 4701
Country 104171 0
Australia
Phone 104171 0
+61 0409875494
Fax 104171 0
Email 104171 0
[email protected]
Contact person for scientific queries
Name 104172 0
Mrs Summer Cannon
Address 104172 0
Central Queensland University, 554-700 Yaamba Rd, Norman Gardens QLD 4701
Country 104172 0
Australia
Phone 104172 0
+61 0409875494
Fax 104172 0
Email 104172 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
Data summaries will be made available but individual data will not. Due to the small sample size, individual data summaries may be recognizable/identifiable by participants or people known to them.


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.