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Clinical Trials/NCT07216287
NCT07216287Enrolling By InvitationNot Applicable

Enhancing Cardiovascular Health in Mothers and Children Through Home Visiting (Supplement)

Washington University School of Medicine1 site in 1 country50 target enrollmentStarted: November 3, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
50
Locations
1
Primary Endpoint
Sleep Health

Study Overview

Brief Summary

This proposal will study sleep health in pregnant women who are of low socioeconomic status (SES) and are participating in the NHLBI-funded UH3 grant: "Enhancing Cardiovascular (CV) Health in Mothers and Children Through Home Visiting (ENRICH)". Objective sleep health will be measured using an in-home sleep disordered breathing testing device and actigraphy and associations of sleep health with social determinants of health and CV health will be investigated. Data from this study will serve as the foundation for future work that will result in the development of sleep interventions and updated guidelines for screening and treatment of sleep in pregnancy.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Currently enrolled in a HV agency participating in ENRICH
  • •Pregnant, with a single or multiple pregnancy, at or less than 34 weeks 0 days gestation
  • •18 years of age or older
  • •low SES (Medicaid eligibility or income at or below the federal poverty line) and/or African American Race and/or Hispanic/Latino ethnicity

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Sleep Health

Time Frame: Baseline

A sleep health index will be calculated using 7-day wrist actigraphy, a single overnight home SDB testing device, and questionnaires. A sleep health index will be calculated using 10 sleep health components. Each component will be dichotomized with 0 indicating "poor" and 1 indicating "healthy". Scores will range from 0-10 with 0 being the poorest and 10 being completely healthy sleep, a score \<7 will indicate "poor sleep health".

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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