Quantifying Maternal Health Using Digital Phenotyping: Protocol for a Longitudinal Observational Study.

Abstract

Background: We present a digital phenotyping protocol designed to continuously and objectively measure behavioral, physiological, and contextual data during pregnancy and the postpartum period using passive sensing from Garmin smartwatches and smartphones, along with active ecological momentary assessments (EMAs). This novel protocol uniquely adapts to the unpredictable timing of childbirth, spanning from the third trimester through 6 weeks post partum, to accurately capture critical temporal changes and maternal-infant outcomes. By providing high-frequency real-time data, this methodology offers comprehensive insights into pregnancy-related behaviors and physiological processes, overcoming the limitations of traditional retrospective self-report methods.

Objective: We aim to develop a protocol for longitudinal data collection supporting digital phenotyping that is optimized for pregnancy and the postpartum period. This protocol leverages the pregnant population's heightened interest in health and tracking. It aims to minimize the burden on the participants, increase retention, and assess the value of wearables compared to smartphones to determine the appropriate data collection methods.

Methods: Data will be collected from 30 nulliparous participants from the start of the third trimester through 6 weeks post partum. This protocol uses 3 distinct 1-time surveys, alongside daily and weekly EMAs, to capture real-time maternal experience data. Passive maternal data-such as activity, vitals, sleep, and location-are collected via smartphones and Garmin smartwatches. Participants are expected to log data about the newborn after delivery through the mobile app Huckleberry. This protocol was developed in collaboration with the Northeastern University Sath Laboratory, which focuses on digital phenotyping and longitudinal data collection, and the Tufts Medical Center's obstetrics and gynecology department, which has expertise in working with the pregnant population.

Results: This study was funded in August 2024. Data collection is projected to run from October 2025 to July 2026. As of September 2025, the study has been approved, and recruitment and data collection are to begin. The results are expected to be published by August 2026. We plan to assess the retention rates, survey and EMA completion rates, wear time of the smartwatch without intervention, and data volume logged in the Huckleberry app. In addition, we will perform digital phenotyping to determine whether the data collected during pregnancy can be used to predict breastfeeding outcomes, delivery outcomes, and maternal-infant well-being.

Conclusions: This protocol integrates the use of digital phenotyping in pregnancy and postpartum research, providing a novel method for capturing real-time indicators of maternal well-being. It will determine the expected rates of data completion and appropriate sample size using a power analysis for a more extensive future study. By integrating smartphone and wearable sensor data, this protocol has the potential to transform the way maternal health clinical interventions are designed and implemented in the future.

International registered report identifier (irrid): PRR1-10.2196/77175.