EMBRACE- BLOOM - Building Literacy and Outcomes Through Observation and Monitoring: Information Needs and Wearable Data in Pregnancy Couples (EMBRACE-BLOOM)

The goal of this observational study (a single-site, prospective longitudinal cohort study) is to understand how the health information needs and information-seeking behaviours of pregnant women and their partners change over time, and to identify the factors linked to unmet information needs, in pregnant women aged 18 or over attending routine first-trimester care in the UK, together with one optional nominated partner (also aged 18 or over), followed from early pregnancy (11-13 weeks' gestation) to around 6-8 weeks postpartum. The main questions it aims to answer are:

How do health information needs and information-seeking behaviours evolve across pregnancy and the postpartum period for women and their partners (measured as longitudinal change in the Information Mismatch Index)? What barriers, facilitators, and sociodemographic factors are associated with unmet information needs, and how do the needs of women and their partners align or diverge?

This study has no comparison group or intervention; it is non-interventional and does not involve randomisation, treatment allocation, or any change to clinical care. Instead of comparing arms, researchers will examine how needs change over time and will explore differences between women and partners, and associations with health literacy, wellbeing, and optional passive digital data.

Participants will:

Complete short app-delivered questionnaires at four milestone timepoints (around 11-13 weeks, 20-22 weeks, 35-36 weeks' gestation, and 6-8 weeks postpartum), each taking no longer than about 20 minutes and covering information needs, information-seeking behaviour, trust, health and digital literacy, mental health, quality of life, social support, and relationship satisfaction.

Optionally complete brief biweekly check-in surveys between milestones (about 2-3 minutes each) on recent information needs.

Optionally consent to electronic health record linkage and to sharing passive smartphone- and wearable-derived health metrics (e.g. steps, sleep, heart rate) via their own devices.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Other: Questionnaires

Detailed Description

Why this study is being done Pregnant women and their partners need reliable health information throughout pregnancy and the period after birth, covering topics such as nutrition, screening tests, medications, labour, newborn care, and maternal physical and mental recovery. Many now use digital sources to find this information. However, the large volume of available material varies in quality and reliability, and it can be difficult to identify sources that are trustworthy, relevant, and accurate. This may contribute to information overload, anxiety, and reliance on advice that does not reflect an individual's circumstances.

Most existing research on pregnancy information needs is cross-sectional, examines a single time point, and includes only the pregnant person rather than their partner. As a result, there is limited longitudinal evidence on how these needs change over time or how they differ between the child bearing person and their partner. This study aims to address this gap and provide evidence to inform the design of maternity information resources.

What the study is EMBRACE-BLOOM is a prospective, non-interventional observational cohort study. It does not test a drug, device, or treatment and does not alter participants' clinical care. The study follows expectant parents through pregnancy and the early postpartum period to document how their health information needs and information-seeking behaviours change over time. It is one independently governed and approved component of the wider EMBRACE programme at King's College London, which aims to improve maternal and infant health through high-quality data and AI-supported approaches.

The study includes both pregnant participants and, optionally, one nominated partner per participant. This design allows comparison of information needs between women and their partners, including where these needs align, where they differ, and how each changes over the course of pregnancy and after birth.

What participation involves Participants are recruited at a routine first-trimester ultrasound appointment and followed remotely through a study smartphone application, without additional study visits. App-delivered questionnaires are completed at four milestone timepoints from early pregnancy to approximately 6-8 weeks postpartum, with optional brief check-in surveys offered between milestones. The questionnaires use validated instruments to assess information needs and information-seeking behaviour, as well as health and digital literacy, mental health, quality of life, social support, and relationship satisfaction.

With separate explicit consent, participants may also choose to contribute electronic health record data relating to their pregnancy and delivery, and passively collected health metrics from their own smartphone or wearable device, such as step count, sleep, and heart rate. These optional data streams allow exploratory analysis of associations between objective health metrics and self-reported information needs and wellbeing. All optional components are opt-in, and participants may withdraw from the study or any individual component at any time without any effect on their clinical care.

Intended outcomes The study will produce longitudinal evidence on when and why parents seek health information, how the needs of women and their partners compare, and how factors such as health literacy and sociodemographic circumstances are associated with access to information. The findings are intended to inform the development of more effective, inclusive, and literacy-appropriate maternity information resources, including evidence on user preferences to guide the design of digital and AI-supported information tools.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • King's College Hospital
    • Contact: Argyro Syngelaki; Phone Number: +44 020 3299 7164; Email: argyro.syngelaki@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from pregnant women aged 18 or over attending a routine first-trimester ultrasound appointment at the Harris Birthright Research Centre for Fetal Medicine, King's College Hospital, London, who are UK residents, able to give informed consent, able to read and understand English sufficiently to complete the study questionnaires, and have access to a compatible smartphone. Each pregnant participant may optionally nominate one partner - any individual identified as providing partner support, regardless of gender or relationship status - who meets the same age, residency, consent, language, and smartphone criteria. This is a demographically diverse urban NHS population.

Description

Inclusion Criteria:

Pregnant participants

• Aged 18 years or over;
• Attending a routine first-trimester ultrasound appointment at the study site;
• Resident in the UK;
• Able to provide informed and documented consent;
• Able to read and understand English sufficiently to complete study questionnaires delivered via the study mobile application;
• Have access to a compatible smartphone.

Partners

• Aged 18 years or over;
• Nominated by a participating pregnant participant;
• Resident in the UK;
• Able to provide informed and documented consent;
• Able to read and understand English sufficiently to complete study questionnaires delivered via the study mobile application;
• Have access to a compatible smartphone.

Exclusion Criteria:

Pregnant participants and partners:

• Under 18 years of age;
• Not resident in the UK;
• Unable to provide informed consent;
• No access to a compatible smartphone.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant participants	Other: Questionnaires; Participants complete validated app-delivered questionnaires at four timepoints across pregnancy and postpartum, assessing information needs, wellbeing, and related measures. No intervention administered.
Partners of pregnant participants	Other: Questionnaires; Participants complete validated app-delivered questionnaires at four timepoints across pregnancy and postpartum, assessing information needs, wellbeing, and related measures. No intervention administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longitudinal change in the Information Mismatch Index (IMI)	The Information Mismatch Index (IMI) measures the gap between participants' health information needs and the information they are able to access and use during pregnancy and the postpartum period. It is derived from self-reported, app-delivered questionnaire items, with higher scores indicating greater unmet information need. The outcome is the change in IMI score across the four milestone timepoints.	Measured at four timepoints from early pregnancy to postpartum: 11+0-13+6 weeks' gestation (T1), 20+0-22+6 weeks (T2), 35+0-36+6 weeks (T3), and 6-8 weeks postpartum (T4).

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Fetal Medicine Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 370088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No