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

NCT ID: NCT06150989

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-04

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases Heart Disease Risk Factors

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Group

Black women enrolled in this study will complete a series of lab-based assessments that evaluate their vascular health, followed by a 10-day free-living monitoring period with mobile and wearable devices.

Observational Group

Intervention Type BEHAVIORAL

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.

Interventions

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Observational Group

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

The University of Texas at Arlington

OTHER

Sponsor Role lead

Responsible Party

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Yue Liao

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Texas at Arlington

Arlington, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Physical Activity and Wearable Sensors Lab

Role: primary

8172728524

References

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Liao Y, Brothers RM, Brown KK, Lee RE. A biobehavioral observational study to understand the multilevel determinants of cardiovascular health in Black women: the BLOOM Study protocol. BMC Womens Health. 2024 Jul 5;24(1):391. doi: 10.1186/s12905-024-03182-0.

Reference Type DERIVED
PMID: 38970037 (View on PubMed)

Other Identifiers

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2023-0344

Identifier Type: -

Identifier Source: org_study_id

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