Cardiovascular DiseasesBLOOMNCT06150989
Black Women's Life Experience On Cardiovascular Health Via Ongoing Monitoring
An observational study of Cardiovascular Diseases and Heart Disease Risk Factors, run by The University of Texas at Arlington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Heart Disease Risk Factors
- What is being tested?
- Observational Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The target population for this study is non-pregnant Black women between the ages of 18 to 49.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Arlington
Arlington, Texas, 76010
About this study
Official title: 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.
- Being tested
- Observational Group
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Observational Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 1
Secondary outcomes (1)
Physical activity
Daily physical activity level will be assessed via a wrist-worn accelerometer.
Measured: Day 2 to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start4 Mar 2024
- Primary completion31 May 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Yue Liao, The University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150989
- Sponsor's protocol ID
- 2023-0344
- Acronym
- BLOOM
- Status last verified
- Jun 2026
- First submitted
- 20 Oct 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 38970037
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biobehavioral Approach to Understand the Multilevel Determinants of Cardiovascular Health in Black Women
- ClinicalTrials.gov ID
- NCT06150989
- Acronym / sponsor ID
- BLOOM / 2023-0344
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Behavioral: Observational GroupBlack 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The target population for this study is non-pregnant Black women between the ages of 18 to 49.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational GroupAll 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. | Behavioural | Observational Group |
Primary outcome
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.
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.
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).
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.
1 secondary outcome
Physical activity
Time frame: Day 2 to Day 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 38970037Liao 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Disease Risk Factors, run by The University of Texas at Arlington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macrovascular function (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06150989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.