Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort

January 5, 2026 updated by: Danielle Prentice, Oregon Health and Science University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Women's Health Research Unit Department of OB/Gyn
  • Phone Number: 503-494-3666
  • Email: whru@ohsu.edu

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wearable Activity Tracker with Data Access
Participants will wear a Garmin Vivosmart 5 wearable activity tracker and have access to the data it collects.
Device: Wearable Activity Tracker
A watch-style wearable activity tracker which tracks steps, heart rate, activity level, and sleep quality.
Other Names:
  • Garmin Vivosmart 5
No Intervention: Blinded Wearable Activity Tracker
Participants will wear a Garmin Vivosmart 5 wearable activity tracker and be blinded to the data it collects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured from study enrollment through 6 weeks postpartum, an average of 26 weeks
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.
Measured at 6 weeks postpartum.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: From enrollment through delivery
The mean number of minutes of physical activity per week recorded by the wearable activity tracker.
From enrollment through delivery

Collaborators and Investigators

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

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Danielle Prentice, DO, Oregon Health and Science University

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00028457

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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