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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Heart Disease Risk Factors
• Intervention / Treatment: Behavioral: Observational Group

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• United States
  • Texas
    • Arlington, Texas, United States, 76010
      • The University of Texas at Arlington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is non-pregnant Black women between the ages of 18 to 49.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macrovascular function	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.	Day 1
Arterial Stiffness	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.	Day 1
Blood Flow Measurements (Large Blood Vessels)	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).	Day 1
Blood Flow Measurements (Cerebral Blood Vessels)	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	Daily physical activity level will be assessed via a wrist-worn accelerometer.	Day 2 to Day 11

Collaborators and Investigators

• Sponsor: The University of Texas at Arlington
• Collaborators: American Heart Association

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2023-0344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual-level study data will be deposited to the ICPSR, an AHA-approved data repository, for sharing behavioral health and social science research data. Codebooks (or data dictionaries) and other study documentation will be made available as PDFs on the ICPSR website.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No