STEP Outpatient Study
Sleep & Tracking activity: Effects in Pregnancy
What is the STEP Outpatient Study?
The STEP study is also known as the Sleep and Tracking Activity: Effects in Pregnancy Study. The outpatient part of this study is a physical activity-based intervention using Fitbit trackers and personalized counseling. It will help researchers to understand whether smart-phone based activity trackers can help high risk pregnant women increase their activity level, and potentially improve perinatal outcomes.
Why am I being asked to participate?
You are being asked to be in the study because you are at a high risk for preterm birth and own a smartphone.
What will I have to do?
We will discuss the study with you in detail. If you agree to participate, you will review an online consent form and HIPAA form in detail.
Once you agree to participate and sign the consent form and the HIPAA form, we will ask you to complete a set of surveys about your diet, stress, sleep, and body image. You will be asked to complete two follow-up sets of surveys during the study. All enrolled women will receive a wrist-based activity tacker (Fitbit); however, you may be randomized to either standard obstetrical care or enhanced counseling. You must wear the Fitbit while both awake and asleep and install the Fitbit application on your smartphone.
If you are randomized to receive enhanced counseling, you will receive detailed information about physical activity in pregnancy, personalized activity goals, in-person counseling at regularly scheduled prenatal visits, and weekly texts until delivery.
Biologic samples (including blood, urine, vaginal swabs, and placental tissue) will be collected at enrollment and at delivery for all participants.
Your study timeline:
We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor.
There are no study-only visits to the hospital or clinic.
Are there any risks?
Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. Collecting the placenta and umbilical cord and cord blood occurs after delivery. The placenta is normally discarded after delivery. Every effort is made to protect your confidentiality.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
You will receive a Fitbit device, water bottle, and sleeping mask. If you already own a compatible activity tracker, you will receive a $25 gift card instead. You may also receive parking passes if needed.
The STEP study is also known as the Sleep and Tracking Activity: Effects in Pregnancy Study. The outpatient part of this study is a physical activity-based intervention using Fitbit trackers and personalized counseling. It will help researchers to understand whether smart-phone based activity trackers can help high risk pregnant women increase their activity level, and potentially improve perinatal outcomes.
Why am I being asked to participate?
You are being asked to be in the study because you are at a high risk for preterm birth and own a smartphone.
What will I have to do?
We will discuss the study with you in detail. If you agree to participate, you will review an online consent form and HIPAA form in detail.
Once you agree to participate and sign the consent form and the HIPAA form, we will ask you to complete a set of surveys about your diet, stress, sleep, and body image. You will be asked to complete two follow-up sets of surveys during the study. All enrolled women will receive a wrist-based activity tacker (Fitbit); however, you may be randomized to either standard obstetrical care or enhanced counseling. You must wear the Fitbit while both awake and asleep and install the Fitbit application on your smartphone.
If you are randomized to receive enhanced counseling, you will receive detailed information about physical activity in pregnancy, personalized activity goals, in-person counseling at regularly scheduled prenatal visits, and weekly texts until delivery.
Biologic samples (including blood, urine, vaginal swabs, and placental tissue) will be collected at enrollment and at delivery for all participants.
Your study timeline:
- Enrollment: up to 20 weeks – surveys + biological samples
- 4 weeks after enrollment: follow-up surveys (online)
- 8 weeks after enrollment: follow-up surveys (online)
- Delivery: biological samples only
We will collect all of your blood when you are having routine clinical blood work as ordered by your doctor.
There are no study-only visits to the hospital or clinic.
Are there any risks?
Study-related risks are low. There is a small chance of bruising, bleeding, or discomfort when we draw your blood, but there are no extra blood draws only for the study. Collecting the placenta and umbilical cord and cord blood occurs after delivery. The placenta is normally discarded after delivery. Every effort is made to protect your confidentiality.
Will it cost me anything to be in the study?
There are no costs to participate.
Will I be paid to participate?
You will receive a Fitbit device, water bottle, and sleeping mask. If you already own a compatible activity tracker, you will receive a $25 gift card instead. You may also receive parking passes if needed.
