When I was pregnant for the first I time, I had many questions. How much weight did other women like me typically gain? Were my leg cramps and lack of sleep in the last trimester normal? What was the optimal amount of exercise to get? Was it normal to crave ice cream at 2 am in the morning? Should I stop taking certain medications? Some of these questions I was able to ask my friends or doctors; however, I quickly learned that not all of my friends experienced the same things as me and there were many generalizations and gaps in the current pregnancy research and guidelines.
Through the Healthy Pregnancy Study, a ResearchKit app run in collaboration with WebMD, my colleagues and I at the Scripps Translational Science Institute hope to collect both survey and sensor related data by from a large and diverse group of pregnant women so that we can provide answers to these questions and others. Ultimately, we hope to better understand how individualized physiological and behavioral changes might impact a healthy pregnancy. We also hope to learn about the benefits and challenges of running an app-based study compared to a traditional research study and in the process find ways to improve enrollment rates, patient engagement, and attract a diverse patient population.
As we created the Healthy Pregnancy Study, we quickly learned that creating a study entirely online through a smartphone had the advantage of being fast and nimble. We were able to create and develop our study app in approximately 9 months, surprisingly the same time as a normal pregnancy and much faster than it would take to put together a similar in-person study. If a change needs to be made, we can make a relatively simple update to the app, without going through the hassle of changing and reprinting paper forms.
Since the study is run entirely online, with self-enrollment and e-consent, we are also able to enroll participants quicker, cheaper, and from a larger and more geographically diverse population compared to traditional research studies. Already, after the first few months of launch we have enrolled over 800 participants from 47 states, including Alaska and Hawaii, and with 13% coming from rural zip codes. However, on the same note, by running the study through an iOS app, we are potentially excluding people who couldn’t afford an iPhone or perhaps have an Android. As the study progresses, we hope to expand to other devices and explore new ways to attract populations who represent all pregnant women.
Another valuable advantage of conducting a study entirely online through an app is that participants have access to all of their study data and can even download it and share it with their health care provider. We also provide them with real-time visualizations of their individual data. As time goes by, we hope to provide more visualizations and feedback to participants about how their data compares to other women like them and how different variables may be associated with pregnancy health outcomes.
One of the challenges with any research study, is keeping participants engaged, which can be especially difficult when the study lasts as long as 9 months and requires weekly surveys. However, we hope that by incorporating more sensors with automatic data upload and by making research simultaneously beneficial and interesting to both participants and researchers we will make a successful long-term research study.
The Healthy Pregnancy Study can be downloaded here: https://itunes.apple.com/us/ap...