Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort

NCT ID: NCT07331909

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Wearable Activity Tracker with Data Access

Participants will wear a Garmin Vivosmart 5 wearable activity tracker and have access to the data it collects.

Group Type: EXPERIMENTAL

Wearable Activity Tracker

Intervention Type: DEVICE

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

Blinded Wearable Activity Tracker

Participants will wear a Garmin Vivosmart 5 wearable activity tracker and be blinded to the data it collects.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wearable Activity Tracker

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

Intervention Type: DEVICE

Other Intervention Names

Garmin Vivosmart 5

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Danielle Prentice

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danielle Prentice, DO

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Central Contacts

Women's Health Research Unit Department of OB/Gyn

Role: CONTACT

whru@ohsu.edu

503-494-3666

Other Identifiers

STUDY00028457

Identifier Type: -

Identifier Source: org_study_id