Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers

Study Overview
=================
Brief Summary
-----------------
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.

Detailed Description
-----------------
The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a medical device. The study involves women age 18 and older who are currently pregnant, at least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are expected to participate in the study. This study will involve review of Owlet Band data and participant responses to questionnaires throughout the study. The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.

Official Title
-----------------
Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers

Conditions
-----------------
Pregnancy, Anxiety, Stress

Intervention / Treatment
-----------------
* Other: Owlet Band


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 24 weeks pregnant with a singleton pregnancy Must be at least 18 years of age Must currently live in the United States Must have a compatible smartphone (Apple iOS Version 13 or above) Able to read and understand English in order to provide Informed Consent and follow study instructions Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Owlet Band|The Owlet Band is a wearable fabric band pregnancy tracker made up of small sensors that are able to detect natural low-level electrical signals normally produced by the mother's heart and baby's (fetal) heart.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gather information | Successful collection of Owlet Band data from study participants | From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks | 
| Gather information | Completion of study questionnaires by at least 500 participants | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of anxiety State Trait Anxiety Inventory | Change in anxiety as assessed by State Trait Anxiety Inventory (STAI) | Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days) | 
| Management of stress (Perceived Stress Scale) | Change in perceived stress as assessed by Perceived Stress Scale (PSS) | Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days) | 
| Participant's experience while using the Owlet Band | Self-report of bonding and connection | Through study completion, up to 16 weeks | 
| Maintenance of standard medical care | Self-Report of standard medical care and unexpected or unscheduled visits | Through study completion, up to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Owlet, Pregnancy, Digital Health, Wellness