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

NCT ID: NCT05709327

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-03
• Study Completion Date: 2025-12-03

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.

Conditions

Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single-arm observational study

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

Group Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tan Kok Hian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kok Hian Tan, MD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Kok Hian Tan, MD

Role: CONTACT

tan.kok.hian@singhealth.com.sg

+6563941099

Phaik Ling, Elaine Quah, PhD

Role: CONTACT

quah.phaik.ling@kkh.com.sg

+6597732543

Facility Contacts

Kok Hian Tan, MD

Role: primary

tan.kok.hian@singhealth.com.sg

+6563941099

Phaik Ling Quah, PhD

Role: backup

quah.phaik.ling@kkh.com.sg

+6597732543

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021/2515

Identifier Type: -

Identifier Source: org_study_id