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NCT05709327 | Not yet recruiting | Pregnancy


Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Sponsor:

KK Women's and Children's Hospital

Information provided by (Responsible Party):

Tan Kok Hian

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).

Condition or disease

Pregnancy

Intervention/treatment

Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 100 participants
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Actual Study Start Date : April 3, 2023
Estimated Primary Completion Date : December 3, 2024
Estimated Study Completion Date : December 3, 2024
Arm Intervention/treatment

Other: Single-arm observational study

All participants in the study will be provided a smart ring to wear for the entire duration of the pregnancy.

Other: Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)

Ages Eligible for Study: 21 Years to 45 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)

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Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)

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