Mums on the Move Study: a pilot randomised controlled trial to evaluate the effectiveness of a physical activity program for women at risk of post-natal depression.

Aims: The primary aim of the Mums on the Move study is to investigate the feasibility of a multi-component 12-week home-environment intervention delivered to mothers at risk of post natal depression (PND) for increasing physical activity, with the view of generating ideas of effect size and informing power calculations for a larger trial in future. The secondary aim is to examine changes in depressive symptoms as a result of participating in the intervention. Participants: The intervention will target 62 (intervention group = 31, control group = 31) mothers living in Melbourne, who are 3-9 months postpartum, classified 'at-risk' of PND, i.e. those who score 10 or greater on the Edinburgh postnatal depression scale (Cox, Holden, and Sagovsky, 1987), and who do not currently own a treadmill or stationary bicycle. Recruitment methods: • Maternal Child Health Centres (MCHC): Presentations (and flyers) to parent groups. • Website advertisements on Post and Antenatal Depression Association (PANDA), Beyond Blue • Social media: Sponsored Facebook advertisements and use of Twitter • Advertisements in local newspapers and at local services (e.g. GP offices, pharmacies) • Snowball techniques Consent: After completion of a short online screening survey, participants will receive a plain language statement and consent form. They will be required to return a signed, completed consent form, along with approval from their GP to participate in physical activity (via a GP consent form) to the research team. Randomisation: After initial screening (and once consent forms are returned) women will be randomly assigned to either the behavioral intervention (n = 31) or control (n= 31) conditions by using a computer-generated block randomization sequence produced and implemented by a statistician that involves blocks of 2 and 4 in varying combinations. Level of education (completed tertiary education/not completed tertiary education) will be applied as a stratification variable during randomisation. To conceal allocation, the randomization sequence will be stored securely and separately from the participant database and will not accessible by investigators who are blinded to participant allocation. Only the statistician and project manager will be informed of the allocation and enrolment of participants. Intervention: Once randomly allocated into the intervention group, participants will be provided with home exercise equipment (free treadmill/stationary bicycle hire), a logbook for goal setting and self-monitoring, access to an online blog (for social support) and low-intensity motivational material (web-app) for 12 weeks. The 12-week PA program is theoretically underpinned, based on constructs of the social cognitive theory (described below) and key behaviour change principles. Materials have been developed and pilot tested, and include: Construct 1 - Physical Environmental: Free exercise equipment (e.g. treadmill/stationary bicycle hire) (12 weeks) and logbook for self-monitoring. Construct 2 - Social: Online blog (for social support and to share tips and ideas on how to get active) since emerging evidence suggests that social media forums may play a role in behaviour change. The online blog forum will be a private page and only participants who are enrolled in this study (in the intervention group), will be able to view this page. The project manager will monitor this forum for the duration of the study, and upon closing of the project, the online blog will be deleted. The project manager will monitor participant comments to ensure the well-being of participants, and to remove any inappropriate comments. Participants will NOT be required to utilise the forum a minimum number of times, but may choose to post comments as frequently as they wish, and only if they wish to do so. If comment numbers are dwindling on the forum, the manager will make a new post reiterating material provided on the web application to continue to encourage participant use of the forum. The majority of topics covered will therefore be driven by the participants themselves. At the conclusion of the 12 week intervention period, the total number of participant comments will be tallied, and content analysis will be performed to determine the proportion of comments relating directly to the intervention. Construct 3 - Intrapersonal: Web-app (e-health) with written PA program tailored to current activity levels (beginner, intermediate, and advanced, and includes 30 minutes of continuous or interval aerobic exercise including warm up and cool down, performed on either a treadmill or stationary bicycle prescribed by the researchers), goal setting information, self-monitoring, motivational information, tips for overcoming barriers to be active and reduce sedentary behaviours (SB). The information provided on the app is a modified version of the web app designed by Teychenne et al. (2018), with additional materials designed specifically for this study. Participants will also be able to access free purposively designed music workout mixes on Spotify, as created by participants according to their music preferences. To determine adherence to the app, the intervention group will be asked at follow up to self-report how often they used the web-app. Data collection: Prior to commencing the intervention period, the intervention group will complete a baseline survey about key study outcomes, including feasibility; objectively (via accelerometer) and self-measured PA and SB; depressive symptoms; theoretical constructs of behaviour change; and mediators. Physical activity will be objectively measured by an accelerometer worn for one week. At Weeks 4 and 8, participants will be contacted via phone to monitor their depressive symptoms, and self-reported physical activity levels and sedentary behaviour. Upon program completion (after 12 weeks), participants will complete a follow-up survey about key study outcomes as detailed above, and will again wear an accelerometer for one week. Cox, Holden, and Sagovsky (1987). Detection of postnatal depression: development of the 10-item Edinburgh Postnatal Depression scale. Brit J Psych, 150(June):782-786. Teychenne, et al (2018). Feasibility and acceptability of a home-based physical activity program for postnatal women with depressive symptoms: a pilot study. Mental Health and Phys Act, 14:82-89.