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

Owlet

Status: Unknown

Conditions: Anxiety; Stress; Pregnancy

Treatments: Other: Owlet Band

Study type: Observational

Funder types: Industry

Identifiers

NCT04419051

OWLB

Details and patient eligibility

About

This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.

Full 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.

Enrollment: 8,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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