Monitored Home Exercise in Pregnancy

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.

A sample size of 25 women for each arm of the study (50 women total) will be recruited. Basic
demographic data will be obtained for all enrolled subjects, including age, parity,
pre-pregnancy BMI, family history of diabetes, history of GDM (and number of previously
affected pregnancies), preterm birth history, and baseline activity level (type of job,
exercise, hours of standing). All participants will be asked to fill out a physical activity
in pregnancy readiness survey as well as a baseline, previously validated international
physical activity questionnaire, which will be utilized for comparison to activity level data
collected during the study period. All enrolled patients will receive a FitBit heart rate +
activity monitor, which will provide overall activity data in the form of steps per day
through the duration of the trial. Those randomized to the intervention group will also
utilize the FitBit during exercise sessions to provide data on duration, heart rate, and
intensity, all of which will confirm that exercise is being accomplished as prescribed. This
immediate exercise compliance feedback will enable automated motivational factors to engage
the patient and optimize their continued exercise participation. Data regarding mode of
delivery as well as infant details will be collected by chart review by the research team.
Long term follow up may be obtained via email surveys, thus patient emails will be obtained
at the time of enrollment.

Inclusion Criteria:

- 18 years of age or greater

- Singleton gestation

- History of gestational diabetes

- OR

- BMI ≥30

- OR

- Significant family history of diabetes (two or more first degree relatives with DM)

Exclusion Criteria:

- Non-English or non-Spanish speaking patients

- Women unwilling to provide consent

- Patients with current diagnosis of diabetes

- Multiple gestation

- Medical or pregnancy complications and/or comorbidities that preclude exercise in
pregnancy

- Unwillingness to commit to the prescribed exercise program