PregnancyNCT04419051
Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
An observational study of Pregnancy and Anxiety, run by Owlet Baby Care, Inc. at 1 site in United States.
Trial summary
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Owlet Band
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women 24 weeks' gestation and later
Who may be able to join
- 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
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Owlet Baby Care, Inc.
Lehi, Utah, 84043
Madison Kenley, BS, CCRC, 801-552-8383, mkenley@owletcare.com
Kenneth Ward, MD
About this study
This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.
Read the 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.
- Being tested
- Owlet Band
- Keywords
- Owlet, Pregnancy, Digital Health, Wellness
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Owlet BandOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gather information
Successful collection of Owlet Band data from study participants
Measured: From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks
Gather information
Completion of study questionnaires by at least 500 participants
Measured: Up to 16 weeks
Secondary outcomes (4)
Management of anxiety State Trait Anxiety Inventory
Change in anxiety as assessed by State Trait Anxiety Inventory (STAI)
Measured: Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)
Management of stress (Perceived Stress Scale)
Change in perceived stress as assessed by Perceived Stress Scale (PSS)
Measured: 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
Self-report of bonding and connection
Measured: Through study completion, up to 16 weeks
Maintenance of standard medical care
Self-Report of standard medical care and unexpected or unscheduled visits
Measured: Through study completion, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start17 Aug 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Owlet Baby Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419051
- Sponsor's protocol ID
- OWLB
- Status last verified
- Sep 2020
- First submitted
- 20 Feb 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
- ClinicalTrials.gov ID
- NCT04419051
- Acronym / sponsor ID
- OWLB
- Keywords
- Owlet, Pregnancy, Digital Health, Wellness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Owlet Baby Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women 24 weeks' gestation and later
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Owlet BandThe 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. | Other | – |
Primary outcome
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
Gather information
Time frame: Up to 16 weeks
Completion of study questionnaires by at least 500 participants
4 secondary outcomes
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)
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)
Participant's experience while using the Owlet Band
Time frame: Through study completion, up to 16 weeks
Maintenance of standard medical care
Time frame: Through study completion, up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Anxiety, run by Owlet Baby Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madison Kenley, BS, CCRC (801-783-3522, mkenley@owletcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.