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

Sponsor
The University of Texas at Arlington (Other)
Overall Status
Recruiting
CT.gov ID
NCT06150989
Collaborator
American Heart Association (Other)
80
1
27
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Observational Group

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
A Biobehavioral Approach to Understand the Multilevel Determinants of Cardiovascular Health in Black Women
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Macrovascular function [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 [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) [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) [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 Outcome Measures

  1. Physical activity [Day 2 to Day 11]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas at Arlington Arlington Texas United States 76010

Sponsors and Collaborators

  • The University of Texas at Arlington
  • American Heart Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yue Liao, Assistant Professor, The University of Texas at Arlington
ClinicalTrials.gov Identifier:
NCT06150989
Other Study ID Numbers:
  • 2023-0344
First Posted:
Nov 30, 2023
Last Update Posted:
Nov 30, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2023