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

Recruiting

• Conditions: Cardiovascular Diseases; Heart Disease Risk Factors
• Interventions: Behavioral: Observational Group

• Registration Number: NCT06150989
• Lead Sponsor: The University of Texas at Arlington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-11-30
• Study Start: 2024-03-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-10
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Group	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.

Primary Outcome Measures

Name	Time	Method
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.
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).
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.
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.

Secondary Outcome Measures

Name	Time	Method
Physical activity	Day 2 to Day 11	Daily physical activity level will be assessed via a wrist-worn accelerometer.

Trial Locations

Locations (1)

The University of Texas at Arlington; 🇺🇸 Arlington, Texas, United States