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

• Conditions: Pregnancy; Stress; Anxiety

• Registration Number: NCT04419051
• Lead Sponsor: Owlet Baby Care, Inc.

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.

Study Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Study Start: 2020-08-17
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 8000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gather information	Up to 16 weeks	Completion of study questionnaires by at least 500 participants

Secondary Outcome Measures

Name	Time	Method
Management of anxiety State Trait Anxiety Inventory	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)
Management of stress (Perceived Stress Scale)	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)
Maintenance of standard medical care	Through study completion, up to 16 weeks	Self-Report of standard medical care and unexpected or unscheduled visits
Participant's experience while using the Owlet Band	Through study completion, up to 16 weeks	Self-report of bonding and connection

Trial Locations

Locations (1)

Owlet Baby Care, Inc.; 🇺🇸 Lehi, Utah, United States