My Exercise My offspring (MEMO) study: a randomised controlled trial to evaluate the effectiveness of a physical activity program for pregnant women

Women up to 18+6 weeks of gestation that present to the Liverpool Hospital antenatal clinic will be provided with the MEMO Flyer, MEMO Participant Information Document, and the PADIP (Physical Activity and Diet in Pregnancy) Questionnaire. The PADIP Questionnaire will also be available via Surveymonkey The flyer will instruct interested women to indicate their wish to participate in this study by either completing the flyer and returning it to the Liverpool Hospital antenatal clinic MEMO box, or sending an email to the investigator as described on the flyer. A set of questions addressing the inclusion and exclusion criteria will be included as part of the PADIP Questionnaire. At the end of the PADIP questionnaire, the women will be invited to read through a detailed explanation of what the MEMO study involves, how the randomisation process works, as well as the risks and benefits of participating in the study. Subsequently, women will be asked to provide consent electronically and a paper version of the consent form will be provided to women without access to the internet. Using information from the PADIP Questionnaire as well as existing medical records, all participants will be assessed for medical and obstetrical factors that may increase their risk for maternal/foetal complications and/or injuries prior to randomisation. Women that fulfil inclusion criteria and consent to participation in the study will be randomised to either the exercise intervention or usual antenatal care. Women will be asked to indicate whether they would like surveys to be sent via email or to be provided as hard copies (provided during antenatal clinic appointment or posted to their address). Consent: all participants will be required to provide informed consent electronically as approved by the South Western Sydney Local Health District Human Research Ethics Committee. Randomisation: randomisation sequence will be created with a computer random number generator with a 1:1 allocation using random block sizes of 2 and 4. The allocation sequence will be concealed from staff enrolling and assessing participants by using sequentially numbered, opaque, sealed and stapled envelopes. Blinding: the nature of this study means that care providers and participants will not be blinded to the intervention allocation. Outcome assessors will be blinded to the intervention allocation. Experimental intervention: Participants in the intervention group will be given the "My Steps Diary" which contains instructions at the front of the booklet for the home/community-based walking program. Women in the intervention group will be invited to engage in moderate intensity walking in their own time at home or in the community as decided by the participant. The duration of the walking intervention will be gradually increased to eventually reach the target of walking at a moderate intensity (roughly 70-100 steps/min) for 30 mins or greater as tolerated on 5-7 days of the week. Due to individual differences, women will be encouraged to aim for moderate intensity walking that is brisk and increases the heart rate and breathing rate but should still allow a normal conversation to be held. Women should only exercise as tolerated and in a cool environment. • walk for around 15 mins at a moderate intensity on 3-4 days per week during week 1 and 2 of the intervention • walk for around 15 mins at a moderate intensity on 5-7 days per week during week 3 and 4 of the intervention • walk for around 15 mins and 30 mins alternately at a moderate intensity on 5-7 days per week during week 5 and 6 of the intervention • walk for around 30 mins (or greater as tolerated) at a moderate intensity on 5-7 days per week thereafter as tolerated. Participants may accumulate episodes of exercises greater than 10 mins to reach the target of 30 mins on 5-7 days of the week. Compliance aid: Women in the intervention group will be sent a link to download a pedometer app (Accupedo) onto their mobile phones. These women will be advised to use the app to record the total distance walked and number of steps taken during the day. The distance walked and number of steps taken during time specifically set aside for physical activity will also be recorded separately. It is proposed that the pedometer app will motivate women to attain their target level of physical activity, and also encourage self-efficacy in monitoring physical activity. Women will be asked to document the distance, number of steps walked daily, and the time spent walking in a "My Steps Diary". At 24-26 weeks of gestation and 34-36 weeks of gestation, women will be asked to complete a survey to determine average amounts of time spent exercising per week. For women choosing to complete the surveys online, the surveys will be emailed to the participants by the principal investigator. Hard copies of the surveys will be provided by the treating clinician/midwife to participants without email access. The Edinburgh Postnatal Depression Scale will be administered at 24-26 weeks of gestation and again at 34-36 weeks of gestation. Hard copies of the surveys will be provided by the treating clinician/midwife to all participants during their antenatal clinic appointment. Patient satisfaction assessed using the MEMO Study Patient Satisfaction Survey to be administered at 8-10 weeks postpartum. For women choosing to complete the surveys online, the surveys will be emailed to the participants by the principal investigator. Hard copies of the surveys will be posted to participants without email access. At 6 months and 1 year postpartum, participants will be sent a survey to evaluate exercise habits and patterns. For women choosing to complete the surveys online, the surveys will be emailed to the participants by the principal investigator. Hard copies of the surveys will be posted to participants without email access.