Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort

NCT07331909 | Not Yet Recruiting

• 1 other identifier: STUDY00028457
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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 activity trackers on physical activity in pregnancy.

Conditions

Pregnancy Related

Keywords

Wearable Activity Tracker

Outcome Measures

Primary Outcomes (2)

• Device use

  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

  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 Outcomes (1)

• Physical activity

  From enrollment through delivery

Study Arms (2)

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.

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.

Interventions

Wearable Activity Tracker DEVICE

A watch-style wearable activity tracker which tracks steps, heart rate, activity level, and sleep quality.

Also known as: Garmin Vivosmart 5

Wearable Activity Tracker with Data Access

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Officials

• Danielle Prentice, DO

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of OB/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and research team members will know which arm participants in. Participants in the blinded arm will not have access to their data from the wearable activity tracker.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01