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

September 29, 2020 updated by: Owlet Baby Care, Inc.
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Lehi, Utah, United States, 84043
        • Recruiting
        • Owlet Baby Care, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women 24 weeks' gestation and later

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gather information
Time Frame: From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks
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
Time Frame: Up to 16 weeks
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
Time Frame: Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)
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)
Time Frame: Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days)
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
Time Frame: Through study completion, up to 16 weeks
Self-report of bonding and connection
Through study completion, up to 16 weeks
Maintenance of standard medical care
Time Frame: Through study completion, up to 16 weeks
Self-Report of standard medical care and unexpected or unscheduled visits
Through study completion, up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Owlet Baby Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 17, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (ACTUAL)

June 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OWLB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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