Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort

Oregon Health & Science University (OHSU)

Status: Not yet enrolling

Conditions: Pregnancy Related

Treatments: Device: Wearable Activity Tracker

Study type: Interventional

Funder types: Other

Identifiers

NCT07331909

STUDY00028457

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Wearable Activity Tracker with Data Access

Experimental group

Description:

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

Treatment:

Device: Wearable Activity Tracker

Blinded Wearable Activity Tracker

No Intervention group

Description:

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