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Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring

A Biobehavioral Approach to Understand the Multilevel Determinants of Cardiovascular Health in Black Women

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06150989
Acronym
BLOOM
Enrollment
80
Registered
2023-11-30
Start date
2024-03-04
Completion date
2027-08-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Disease Risk Factors

Brief summary

This pilot study uses a state-of-the-science combination of remote behavioral monitoring, real-time experience sampling, in-lab physiological assessments, and extraction of neighborhood-level characteristics to (1) Examine the impact of daily experience (i.e., racial discrimination, affective states, stress) on health behaviors (i.e., physical activity, sedentary behavior, sleep) at the intrapersonal level among Black women; (2) Test the association between daily behaviors and impairments in biomarkers associated with vascular function/health (i.e., augmented systemic inflammation and oxidative stress, impaired peripheral/cerebral vascular function, increased large artery stiffness), as well as the impact of daily experience on the relationship between behaviors and vascular function; and (3) Explore the influence of neighborhood-level characteristics (i.e., social environment factors: i.e., neighborhood income and poverty, racial composition; and built environment context, such as park density and walkability) on daily experience and health behaviors.

Interventions

All participants will go through a series of lab-based assessments to evaluate their vascular health. These assessments include: heart rhythm/rate, blood pressure, large blood vessel flow, central aortic blood pressure and pulse wave velocity, brain blood flow, carbon dioxide concentration, flow mediated dilation/blood vessel responsiveness, breathing rate, and cerebral vasomotor reactivity. In addition, venous blood sample will be taken to identify biomarkers that are associated with elevating blood pressure and decreasing blood flow. The 10-day monitoring period includes a wrist-worn activity tracker and a blood pressure monitor bracelet; a smartphone app that will prompt surveys up to 6 times a day to assess behaviors, social/physical context, mood/stress, and experience of racial discrimination/microaggression. Participants will also collect saliva samples on three consecutive days during the 10-day monitoring period.

Sponsors

The University of Texas at Arlington
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* born and identified as female; * between 18-49 years old; * self-identify as Black or African American; * not currently pregnant; * ownership of a smartphone with Internet access; * able to speak and read English

Exclusion criteria

* diagnosed hypertension, cardiovascular, respiratory, metabolic, and/or neurological disorders; * functional limitations or health issues that preclude physical activity; * currently taking medications for thyroid function or psychological conditions such as depression, anxiety, and mood disorders; * current use of oral or inhalant corticosteroids for asthma; * have regularly smoked within the last 2 years.

Design outcomes

Primary

MeasureTime frameDescription
Macrovascular functionDay 1Macrovascular function will be assessed as brachial artery vasodilation following a period of suprasystolic cuff occlusion. Microvascular function will be assessed as the % change in blood velocity from baseline following cuff release.
Arterial StiffnessDay 1An appropriately sized blood pressure cuff will be placed on the upper arm and central (aortic) and peripheral (arm) blood pressure will be assessed using the non-invasive SphygmoCor Xcel device. This device provides measurement of augmentation index (in percentage), which is an indicator of arterial stiffness.
Blood Flow Measurements (Large Blood Vessels)Day 1A Doppler ultrasound probe will be used to measure blood flow in the upper arm, leg, and/or neck (e.g., brachial artery, femoral artery, and carotid artery, respectively).
Blood Flow Measurements (Cerebral Blood Vessels)Day 1Cerebral blood flow will be indexed from the velocity of blood flowing through the middle cerebral artery. This will be accomplished using transcranial Doppler ultrasound.

Secondary

MeasureTime frameDescription
Physical activityDay 2 to Day 11Daily physical activity level will be assessed via a wrist-worn accelerometer.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026