NCT05709327 Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
| NCT ID | NCT05709327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-03 |
| Primary Completion | 2025-12-03 |
Trial Parameters
Eligibility Fast-Check
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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).
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