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

Cardiovascular Diseases Clinical Trial

— BLOOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150989
• Other study ID #: 2023-0344
• Status: Recruiting
• Start date: March 4, 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: The University of Texas at Arlington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas at Arlington	Arlington	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas at Arlington	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Physical activity	Daily physical activity level will be assessed via a wrist-worn accelerometer.	Day 2 to Day 11