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

NCT07623096 | Not Yet Recruiting

• 1 other identifier: 370088
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Pregnant participants

Other: Questionnaires

Partners of pregnant participants

Other: Questionnaires

Interventions

Questionnaires OTHER

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; Pregnant participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Fetal Medicine Foundation: collaborator

Study Sites (1)

King's College Hospital

London, United Kingdom

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

GB (1)