A Randomized Controlled Trial of the Feasibility and Adherence of a Prescribed, Monitored Home Exercise Program in High Risk Pregnant Women

The obesity epidemic has affected the reproductive age population with a resultant increase in Gestational Diabetes Mellitus (GDM). Two to 10% of pregnant women are now diagnosed with gestational diabetes, imposing significant increased risk of maternal and fetal/neonatal morbidity and mortality.

Diabetes and obesity can both be combated by participating in daily physical activity, and has been shown to be beneficial for women of all ages, including women that are pregnant. The health benefits of exercise in pregnancy have been extensively studied, demonstrating improved pregnancy outcomes [both maternal (decreased gestational weight gain, decreased rates of cesarean section, and reduced rates of pregnancy induced complications such as hypertension and pre-eclampsia) and neonatal (reduction in proportion of large for gestational age infants)] with no evidence of harm when not contraindicated. Research should now focus on determining the most feasible, constructive, and efficient methods to improve fitness in pregnant women.

Pregnancy provides an ideal opportunity to focus on physical health and fitness; however, physical activity recommendations are rarely met and physical activity consistently decreases in pregnancy. With the development of mobile, technology-based interventions, at-home fitness regimens are now more accessible, thus reducing logistical constraints and burdens posed by traditional physical activity interventions. Moreover, the sustainability of at-home fitness regimens may be more successful long-term/post-intervention due to ease of engagement and more personalized motivational tools. Finally, wearable technology provides real-time feedback of progress and compliance to the intervention team, allowing improved monitoring of goals and compliance. In this way, contemporaneous, mobile health technology can maximize patient care by providing a novel, efficient, low burden, and scalable method to pursue pregnancy fitness, the economic implications of which could be significant.

The objective of this study is to determine the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.

There will be two arms of the study: an intervention group that will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription, and a comparison group who will receive standard obstetric care, which will include counseling about diet and exercise utilizing American Congress of Obstetricians and Gynecologists (ACOG) guidelines and literature, as well as a FitBit heart rate + activity monitor to track activity levels via step count. The project team will not interact with the comparison group regarding the patient's activity levels during the study duration.