Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wearable Activity Tracker

    Device

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Wearable Activity Tracker with Data AccessExperimental treatment 1 intervention
Group B: Blinded Wearable Activity TrackerNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Device use

The number of days that participants wear the study device during the study period

Time frame
Measured from study enrollment through 6 weeks postpartum, an average of 26 weeks
2

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.

Time frame
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.

Time frame
From enrollment through delivery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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