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

NCT ID: NCT04419051

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-17

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy Anxiety Stress

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Owlet Baby Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Owlet Baby Care, Inc.

Lehi, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Madison Kenley, BS, CCRC

Role: CONTACT

801-783-3522

Kenneth Ward, MD

Role: CONTACT

801-783-3522

Facility Contacts

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Madison Kenley, BS, CCRC

Role: primary

801-552-8383

Other Identifiers

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OWLB

Identifier Type: -

Identifier Source: org_study_id

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