Effect of an exercise intervention on the sleep of sedentary Australian pregnant women

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.