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NCT Number: NCT06150989

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases Heart Disease Risk Factors

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

The University of Texas at Arlington

Arlington, Texas, 76010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational group

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.

Primary outcomes

  1. Macrovascular function

    Time frame: Day 1

    Macrovascular 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.

  2. Arterial Stiffness

    Time frame: Day 1

    An 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.

  3. Blood Flow Measurements (Large Blood Vessels)

    Time frame: Day 1

    A 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).

  4. Blood Flow Measurements (Cerebral Blood Vessels)

    Time frame: Day 1

    Cerebral 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 outcomes

  1. Physical activity

    Time frame: Day 2 to Day 11

    Daily physical activity level will be assessed via a wrist-worn accelerometer.

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: BLOOM

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 30, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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