Increasing Physical Activity Through a Mobile Health Intervention Among Pregnant and Postpartum Women in a Rural Setting

A mobile application (app) that can increase physical activity during and after pregnancy is novel, timely, and critically important to maternal health. Mobile phone-based interventions show significant promise because they can be tailored to the target population, can be delivered at any place and at any time (with or without internet connection), are interactive, and are accessible to the majority of the population irrespective of socioeconomic status (96% of U.S. women ages 18-49 own smartphones). The use of mHealth apps has been associated with behavior change, specifically adaptation of healthy lifestyle approaches. The majority of pregnant women report using an app related to pregnancy; it is the health condition with the highest number of apps available. However, high-quality evidence-based mobile apps that address physical activity specifically for pregnancy do not exist. The overarching goal of this randomized controlled clinical trial is to test the efficacy of the mHealth app for improving physical activity levels among pregnant and postpartum women in a rural setting. Secondary outcomes include weight status, dietary intake, glucose tolerance, blood pressure, and mental health.

After contact is established and eligibility confirmed, participants (N=176) will undergo a screener, a baseline assessment, and then randomized to the mHealth intervention or the attention control group. All participants will have data collected at the following timepoints: baseline (13-15 weeks pregnant), mid-pregnancy (23-25 weeks), late pregnancy (35-37 weeks), and postpartum (6 and 12 weeks). [Of note, 12-week interventions during pregnancy are customary and have been shown to elicit clinically meaningful changes in outcomes. The pilot study protocol was 12 weeks of pregnancy and 12 weeks postpartum.] The proposed RCT will add an additional timepoint in early pregnancy (13-15 weeks), which will increase the length of the intervention to 39+ weeks. This will further enhance the likelihood of the intervention influencing behavior and outcomes.

There will also be three check-ins via telephone (two during pregnancy and one during postpartum upon medical clearance at ~6 weeks) to aid with retention, as well as allow participants to ask any questions about the app (intervention) or the educational brochure (attention control). The 13-15 week gestation time point was chosen because most women have had an initial prenatal appointment (to ensure viability) and the risk of miscarriage substantially reduced. The late pregnancy timepoint was selected as women tend to become the least active during late pregnancy. Six weeks postpartum was selected as this is when most women have their only postpartum clinical appointment (i.e. opportunity for objective clinical data extraction). The 12-week time point is important for assessing behavior as women transition back into activity after medical clearance, which is important for long-term sustained activity.

After the baseline assessment (13-15 weeks gestation), the women will be randomized to the intervention or attention control group. The intervention group will receive free access to the mobile app (BumptUp®). BumptUp® users will watch an introductory video on the app's features which reiterates the goal of the app: to reach the recommended 150 minutes per week of physical activity. The app contains evidence-based workout information and education as well as several resources aimed at increasing physical activity and overcoming barriers for women during and after pregnancy. Each app feature is not only developed as the result of feedback from rural study participants, but is developed with a specific mechanism for behavior change in mind.

The attention control group will undergo the exact same study protocol (parallel) and receive the same amount of interaction from the study team; however, participants will obtain an electronic evidence-based educational brochure about physical activity and dietary intake during pregnancy instead of access to BumptUp®. To ensure the control group is a true attention control, the study team has paid careful attention to recommendations and will ensure that the control group receives the exact same amount of interpersonal interaction as intervention participants (same number of emails, phone calls, surveys, and face-to-face interactions). Instead of a tutorial on the app at the time of randomization, participants will have an educational session with the study team about the educational brochure.