Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wearable Activity Tracker.
- Who it may be relevant to
- Registry conditions: Pregnancy Related. Basic parameters: 18 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Wearable Activity Tracker
A watch-style wearable activity tracker which tracks steps, heart rate, activity level, and sleep quality.
Primary outcome measures
- Device use [Time frame: Measured from study enrollment through 6 weeks postpartum, an average of 26 weeks]
- Participant satisfaction [Time frame: Measured at 6 weeks postpartum.]
Secondary outcome measures (1)
- Physical activity [Time frame: From enrollment through delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07331909 · STUDY00028457