Clinical trial NCT05709327: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Official title: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm observational study
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion criteria:

1. From the first to third trimester of pregnancy (4-39 weeks of gestational age)
2. Mobile phone's operating system supported by the smart ring application.
3. Aged 21 and above

Exclusion criteria:

1. Can't read or speak English
2. Below 21 years of age
3. Below or above gestational age limit
4. Limited mobility
5. Diagnosed with severe unstable mental conditions
6. Diagnosed with severe chronic disorders
7. Mobile device not compatible with smart ring

Primary outcomes:
measure: Feasibility and applicability of smart ring usage during pregnancy
timeFrame: At the end of pregnancy
Secondary outcomes:
measure: Objective change in sleep quality across the entire pregnancy
timeFrame: up to 37 weeks from recruitment
measure: Self-reported change in sleep quality
timeFrame: First trimester of pregnancy between 0-12 weeks gestational age
measure: Self-reported change in sleep quality
timeFrame: Second trimester of pregnancy between 13-27 weeks gestational age
measure: Self-reported change in sleep quality
timeFrame: Third trimester of pregnancy between 28-40 weeks gestational age
measure: Objective change in physical activity across the entire pregnancy
timeFrame: up to 37 weeks from recruitment
measure: Self-reported change in physical activity
timeFrame: First trimester of pregnancy between 0-12 weeks gestational age
measure: Self-reported change in physical activity
timeFrame: Second trimester of pregnancy between 13-27 weeks gestational age
measure: Self-reported change in physical activity
timeFrame: Third trimester of pregnancy between 28-40 weeks gestational age
measure: Anxiety and depression symptoms
timeFrame: First trimester of pregnancy between 0-12 weeks gestational age
measure: Change in anxiety and depression symptoms across the first, second and third trimesters
timeFrame: Second trimester of pregnancy between 13-27 weeks gestational age
measure: Change in anxiety and depression symptoms across the first, second and third trimesters
timeFrame: Third trimester of pregnancy between 28-40 weeks gestational age
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Kok Hian Tan, MD
role: PRINCIPAL_INVESTIGATOR
References: