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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04419051
• Other study ID #: OWLB
• Status: Recruiting
• Start date: August 17, 2020
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Owlet Baby Care, Inc.
• Contact: Madison Kenley, BS, CCRC
• Phone: 801-783-3522
• Email: mkenley[@]owletcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pregnancy
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Owlet Baby Care, Inc.	Lehi	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Owlet Baby Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Gather information	Completion of study questionnaires by at least 500 participants	Up to 16 weeks
Secondary	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)
Secondary	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)
Secondary	Participant's experience while using the Owlet Band	Self-report of bonding and connection	Through study completion, up to 16 weeks
Secondary	Maintenance of standard medical care	Self-Report of standard medical care and unexpected or unscheduled visits	Through study completion, up to 16 weeks