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NCT Number: NCT07331909

Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort

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.

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Key information

Conditions

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable Activity Tracker

Device

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

Other names: Garmin Vivosmart 5

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Physical activity

    Time frame: From enrollment through delivery

    The mean number of minutes of physical activity per week recorded by the wearable activity tracker.

Study contacts

Contact information is provided by the study sponsor or research team.

Women's Health Research Unit Department of OB/Gyn

CONTACT

[email protected]

503-494-3666

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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