Pregnancy RelatedNCT07331909
Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort
A study testing Wearable Activity Tracker in people with Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a randomized controlled pilot study to evaluate the utility of the Garmin Vivosmart 5 wearable activity tracker in pregnancy. It will determine the feasibility of assessing physical activity in pregnant patients using wearable activity trackers and collect pilot data on the behavioral impact of wearable… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Wearable Activity Tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Establishing pregnancy care at Oregon Health \& Science University
- Gestational age less than or equal to 24 weeks and 6 days
- Ability to read, write and speak English
- Ability to upload data either at home via a stable internet connection or in clinic
Who cannot join
- Non-English speaking
- Inability to wear wearable fitness technology due to allergy or sensory issues
- Inability to upload data from wearable fitness technology due to lack of stable internet connection or ability to come to clinic for upload via the research team in the timeframe required
- Inability to answer electronic questionnaires
- Specific contraindication to increased physical activity in pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
This is a randomized controlled pilot study to evaluate the utility of the Garmin Vivosmart 5 wearable activity tracker in pregnancy. It will determine the feasibility of assessing physical activity in pregnant patients using wearable activity trackers and collect pilot data on the behavioral impact of wearable activity trackers on physical activity in pregnancy.
Read the detailed description
Pregnant participants will be given a Garmin Vivosmart 5 wearable activity tracker. They will be randomized 1:1 as to whether they are able to see their personal activity information or being blinded to it. Participants will complete a questionnaire on their physical activity levels before initiating use of the activity tracker and following delivery. Participants' physical activity data, satisfaction with the device, and gestational and delivery outcomes will be collected.
- Conditions
- Pregnancy Related
- Being tested
- Wearable Activity Tracker
- Keywords
- Wearable Activity Tracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Activity TrackerDevice
Also called Garmin Vivosmart 5
A watch-style wearable activity tracker which tracks steps, heart rate, activity level, and sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Activity Tracker with Data Access | Experimental | Participants will wear a Garmin Vivosmart 5 wearable activity tracker and have access to the data it collects. Receives: Device: Wearable Activity Tracker |
| Blinded Wearable Activity Tracker | No intervention | Participants will wear a Garmin Vivosmart 5 wearable activity tracker and be blinded to the data it collects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device use
The number of days that participants wear the study device during the study period
Measured: Measured from study enrollment through 6 weeks postpartum, an average of 26 weeks
Participant satisfaction
Participant survey question asking "On a scale of 1 to 100, how satisfied were you with the activity tracker?" With a higher value representing a greater degree of satisfaction.
Measured: Measured at 6 weeks postpartum.
Secondary outcomes (1)
Physical activity
The mean number of minutes of physical activity per week recorded by the wearable activity tracker.
Measured: From enrollment through delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start16 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will wear the Garmin Vivosmart 5 wearable activity tracker. Participants will be randomized 1:1 to whether they have access to their activity data from the tracker or if they are blinded to their activity tracker.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Prentice, Oregon Health and Science University
- Investigators
- Danielle Prentice, DO, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331909
- Sponsor's protocol ID
- STUDY00028457
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort
- ClinicalTrials.gov ID
- NCT07331909
- Acronym / sponsor ID
- STUDY00028457
- Conditions
- Pregnancy Related
- Keywords
- Wearable Activity Tracker
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Jan 2026 (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 a randomized controlled pilot study to evaluate the utility of the Garmin Vivosmart 5 wearable activity tracker in pregnancy. It will determine the feasibility of assessing physical activity in pregnant patients using wearable activity trackers and collect pilot data on the behavioral impact of wearable activity trackers on physical activity in pregnancy.
Detailed description
Pregnant participants will be given a Garmin Vivosmart 5 wearable activity tracker. They will be randomized 1:1 as to whether they are able to see their personal activity information or being blinded to it. Participants will complete a questionnaire on their physical activity levels before initiating use of the activity tracker and following delivery. Participants' physical activity data, satisfaction with the device, and gestational and delivery outcomes will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will wear the Garmin Vivosmart 5 wearable activity tracker. Participants will be randomized 1:1 to whether they have access to their activity data from the tracker or if they are blinded to their activity tracker.
| Arm | Type | Receives |
|---|---|---|
| Wearable Activity Tracker with Data Access | Experimental | Device: Wearable Activity TrackerParticipants will wear a Garmin Vivosmart 5 wearable activity tracker and have access to the data it collects. |
| Blinded Wearable Activity Tracker | No intervention | –Participants will wear a Garmin Vivosmart 5 wearable activity tracker and be blinded to the data it collects. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Establishing pregnancy care at Oregon Health \& Science University
- Gestational age less than or equal to 24 weeks and 6 days
- Ability to read, write and speak English
- Ability to upload data either at home via a stable internet connection or in clinic
Key exclusion criteria (5 listed)
- Non-English speaking
- Inability to wear wearable fitness technology due to allergy or sensory issues
- Inability to upload data from wearable fitness technology due to lack of stable internet connection or ability to come to clinic for upload via the research team in the timeframe required
- Inability to answer electronic questionnaires
- Specific contraindication to increased physical activity in pregnancy
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 |
|---|---|---|
| Wearable Activity TrackerAlso: Garmin Vivosmart 5A watch-style wearable activity tracker which tracks steps, heart rate, activity level, and sleep quality. | Device | Wearable Activity Tracker with Data Access |
Primary outcome
Device use
Time frame: Measured from study enrollment through 6 weeks postpartum, an average of 26 weeks
The number of days that participants wear the study device during the study period
Participant satisfaction
Time frame: Measured at 6 weeks postpartum.
Participant survey question asking "On a scale of 1 to 100, how satisfied were you with the activity tracker?" With a higher value representing a greater degree of satisfaction.
1 secondary outcome
Physical activity
Time frame: From enrollment through delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
Danielle Prentice, DO principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Activity Tracker in people with Pregnancy Related, run by Oregon Health and Science University 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device use (time frame: Measured from study enrollment through 6 weeks postpartum, an average of 26 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 30 Oct 2026.