Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
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: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART).
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 21 years — 45 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
- Singapore
- 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 study aims to test the following hypotheses in a single-arm observational study in 70-100 healthy pregnant multi-ethnic women who will be followed-up from the first trimester of pregnancy to the third trimester of pregnancy. Aim 1: To assess the applicability, acceptability and compliance with the use of a wearable smart ring together with smart digital devices (e.g., smart phone) during pregnancy. Hypothesis 1: The investigators hypothesize that participants will respond favorably to the use of the smart ring to monitor their physical activity and sleep during pregnancy. Aim 2: To assess the association between maternal characteristics (age, pre-pregnancy BMI, pregnancy weight gain, stress, anxiety and depression symptoms) with physical activity markers (energy expenditure, and step count) and sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability) collected from the smart ring in the second trimester of pregnancy. Hypothesis 2: The investigators hypothesize that specific maternal characteristics will be associated with physical activity markers (energy expenditure, and step count), as well as sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability).
Detailed description
Wearable sensor and other smart technologies may play an important part in the early detection of adverse pregnancy-related health events along with motivating improvement in patient and provider interactions for effective pregnancy health management. The use of wearable sensors, more specifically, wearable smart rings can potentially be used to offer remote, unobtrusive personalized care, encourage preventive care and provide the necessary context for self-help based just-intime adaptive interventions (feedback loops utilizing digital phenotyping data to trigger in-app interventions). Studies on the use of wearable smart rings and health outcomes are scarce, and currently there is no available data of the use of wearable smart rings together with smart digital devices (i.e., smart phone) for tracking pregnancy health in women. This study aims to be the first to generate preliminary pilot data to support it's use in this specific group of women.
An observational period for up to 37 weeks, single-center, one-armed intervention study involving 70-100 healthy pregnant women from a multi-ethnic population (Chinese, Malay, Indian, others) aged between 21 and 45 years.
All participants included into the study will be provided an Oura Ring to wear for the rest of the pregnancy period.
Data will be collected through questionnaires and each time a participant opens up their mobile application, the uploaded data will be automatically transferred via Bluetooth connection to the study database in the smart ring cloud service. The questionnaires include socio-economic factors, maternal anxiety and depression, maternal sleep, and maternal physical activity. The participants data will be collected from the moment join the study up till delivery.
Interventions
- Other Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Single-arm observational study where all participants in the study will be given a smart ring (Oura Ring) to wear throughout the duration of the study.
Primary outcome measures
- Feasibility and applicability of smart ring usage during pregnancy [Time frame: At the end of pregnancy]
Secondary outcome measures (11)
- Objective change in sleep quality across the entire pregnancy [Time frame: up to 37 weeks from recruitment]
- Self-reported change in sleep quality [Time frame: First trimester of pregnancy between 0-12 weeks gestational age]
- Self-reported change in sleep quality [Time frame: Second trimester of pregnancy between 13-27 weeks gestational age]
- Self-reported change in sleep quality [Time frame: Third trimester of pregnancy between 28-40 weeks gestational age]
- Objective change in physical activity across the entire pregnancy [Time frame: up to 37 weeks from recruitment]
- Self-reported change in physical activity [Time frame: First trimester of pregnancy between 0-12 weeks gestational age]
- Self-reported change in physical activity [Time frame: Second trimester of pregnancy between 13-27 weeks gestational age]
- Self-reported change in physical activity [Time frame: Third trimester of pregnancy between 28-40 weeks gestational age]
- Anxiety and depression symptoms [Time frame: First trimester of pregnancy between 0-12 weeks gestational age]
- Change in anxiety and depression symptoms across the first, second and third trimesters [Time frame: Second trimester of pregnancy between 13-27 weeks gestational age]
- Change in anxiety and depression symptoms across the first, second and third trimesters [Time frame: Third trimester of pregnancy between 28-40 weeks gestational age]
Eligibility criteria
Inclusion criteria
- From the first to third trimester of pregnancy (4-39 weeks of gestational age)
- Mobile phone's operating system supported by the smart ring application.
- Aged 21 and above
Exclusion criteria
- Can't read or speak English
- Below 21 years of age
- Below or above gestational age limit
- Limited mobility
- Diagnosed with severe unstable mental conditions
- Diagnosed with severe chronic disorders
- Mobile device not compatible with smart ring
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Singapore · 1 center
- KK Women's and Children's Hospital — Singapore
Identifiers
NCT: NCT05709327 · 2021/2515