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

Sponsor
King's College London
Study ID
NCT07623096
Status
Not Yet Recruiting

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Conditions

  • Pregnancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Jun 3, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Pregnant participants
  • Arm: Partners of pregnant participants

Primary Outcome Measure

Longitudinal change in the Information Mismatch Index (IMI) [ Time Frame: 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). ]

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