A pilot randomised controlled implementation study to support women at high-risk of cardiometabolic pregnancy complications

This is a randomised controlled pragmatic implementation trial to optimise lifestyle management and screening of Diabetes Mellitus Type 2 (DM2) and Cardiovascular Disease (CVD) in women who are at high risk of developing Gestational Diabetes Mellitus (GDM) and Hypertensive Disorders in Pregnancy (HDP) during pregnancy. The intervention includes health coaching support from enrolment in the study (late 1st trimester/early 2nd trimester) until seven months postpartum. There will be three 30-minute health coaching sessions at 17-weeks gestation, 18-weeks gestation and 36-weeks gestation. There will be one optional check-in session between 28-29-weeks gestation, which will run for approximately 30-minutes. In the postpartum period, there will be two core sessions at 3 and 4 months postpartum and three optional checks in sessions at 5, 6 and 7 months postpartum. All of these sessions will run for approximately 30-minutes each. The health coaching will be delivered in person or via telehealth, and will use a mixture of synchronous sessions, asynchronous support (videos and resources) and text messaging. The health coaching includes automated reminders, techniques to support behavioural lifestyle change, and information related to understanding risk of cardiometabolic pregnancy conditions such as GDM or HDP, DM2 and CVD, healthy eating and physical activity, healthy gestational weight gain, breastfeeding and mental, social and environmental considerations through 1:1 participant contact, text messages and providing access to a website with resources. The primary outcome for the RCT component is screening for DM2 or CVD at 12 months postpartum (yes screening occurred; vs not done). Exposure to intervention: Individuals in the intervention arm of the study will receive automated, and non-automated motivational push notification messages and reminders from their health coach. These text messages will be sent using a clinical study mobile phone. At the conclusion of each text message, participants will be asked to reply Y or N to whether the information was helpful (Y) or not (N) and/or Y or N (yes or no) to confirming that they will attend their upcoming appointment (depending on the type of text message was sent). These replies will be recorded in study databases by health coaches. At the conclusion of the study, the number and type of text message replies received from participants (Y or N) will be accessed and this data will be used to determine the total number of messages received by everyone and the engagement with message content (information, motivational, reminder). This will be used to generate an exposure index for each message type, for which the denominator will be the highest number of messages received by any one individual participant. Individuals in the intervention arm of the study will be sent pre-recorded videos and educational content prior to each coaching session. The pre-recorded videos will be uploaded to YouTube and then embedded into Qualtrics (delivery platform) so that researchers can measure how viewers/participants interact with the videos. The types of metrics that will be measured include impressions, view rate, “video played to”, engagement, and clicks. • Impressions (in-feed): this metric is counted when the viewer views the thumbnail of the video. • View rate: the view rate determines the percent of impressions that resulted in a view. • “Video played to”: this metric counts the percentage of people who watched 25%, 50%, 75%, or 100% of the video out of the viewers who initiated the player. Quartile reporting can be used alongside other metrics, such as view rate and audience retention (in YouTube Analytics data) to check roughly where video users are dropping off. • Engagement: for videos longer than 10 seconds, engagements give provides a sense of the frequency of viewers engaging beyond just the impression. • Clicks: the number of times the video is “clicked on” or accessed. The workbook material and additional resources will be available in a click-through format as well as downloadable PDF documents. The number of downloads will be reviewed to assess interaction with the intervention.