- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04576338
"Neighborhood Disadvantage, Sleep and Vascular Health" (NDSVH)
August 12, 2024 updated by: Austin Robinson, Auburn University
"Neighborhood Disadvantage, Sleep, and Vascular Health: Racial Disparities in Cardiometabolic Health and Blood Pressure"
The purpose of the study is to find out the effects of neighborhood disadvantage and sleep disparities contribute to racial disparities in cardiometabolic health and blood pressure in young adults.
Study Overview
Status
Completed
Detailed Description
There are well-documented disparities between Black and white Americans in the incidence of cardiovascular disease, the leading cause of death in America.
There are also disparities between Black and White Americans in the incidence of hypertension (high blood pressure; BP), which is the leading risk factor for cardiovascular disease.
Our long-term goal is to determine effective strategies to prevent racial disparities in cardiovascular health.
In this proposal, the investigators will focus on determining societal and biological mediators of racial disparities in young adults that can be targeted in future interventions.
Poor sleep is associated with adverse cardiovascular events and hypertension.
Moreover, recent meta-analyses demonstrate that Black adults have consistently poorer sleep health than White adults, including receiving fewer total sleep minutes and having worse overall sleep quality.
Neighborhood socioeconomic environments influence health behaviors through both material resources (e.g., access to healthful foods and safe public space) and social norms (e.g.
exercise, diet, smoking).
A well-documented history of discriminatory policies and practices has resulted in black individuals living in more disadvantaged physical and social environments than whites.
As such, they experience greater adverse exposures (e.g., racism, violence and stress), which negatively impact sleep, resulting in dysregulation of cardiometabolic health.
Therefore, the investigators seek to determine the role of neighborhood disadvantage and sleep in contributing to racial disparities in cardiovascular health.
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Auburn, Alabama, United States, 36949
- Kinesiology Building
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The cohort consists of Black and White college students at a university in a southeastern state in America.
The cohort will be, by design, generally healthy, young adults free from known cardiometabolic disease,
Description
Inclusion Criteria:
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Exclusion Criteria:
- Systolic blood pressure greater than 150 mmHg
- Diastolic blood pressure greater than 90 mmHg
- Body mass index above 35 kg/m^2
- History of cardiovascular disease
- Recent (one year) history of cancer
- History of metabolic disease (e.g. type 2 diabetes)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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College Students
The cohort consists of Black and White college students at a university in a southeastern state in America.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Flow-mediated dilation (FMD)
Time Frame: Baseline racial comparison
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Flow-mediated vasodilation will be assessed using continuous measures of brachial artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70).
The brachial artery will be imaged in the longitudinal plane proximal to the medial epicondyle using a high-frequency (6-12 MHz) linear-array probe.
The ultrasound probe will be stabilized using a custom-built clamp.
Shear rate (sec-1) will be calculated as [(blood flow velocity (cm*s-1) *4)/blood vessel diameter (mm)] The image will be recorded throughout a 60-s baseline, a 300-s ischemic stimulus (250 mmHg), and 180 seconds post deflation.
FMD will be expressed as % dilation (final diameter-baseline diameter/baseline diameter x 100) and also normalized to the shear stimulus.
Allometric scaling will be used if appropriate, including if there are baseline differences in artery diameter by race or condition.
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Baseline racial comparison
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Pulse wave velocity (arterial stiffness)
Time Frame: Baseline racial comparison
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The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV).
A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid pulse.
Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded.PWV will be expressed as cm/s.
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Baseline racial comparison
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Pulse wave analysis (arterial stiffness)
Time Frame: Baseline racial comparison
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The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) using an upper arm blood pressure cuff.
PWA will be expressed as % (calculated as augmentation pressure divided by the pulse pressure).
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Baseline racial comparison
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24-hour ambulatory blood pressure
Time Frame: Baseline racial comparison
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Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours preceding their study visit to measure systolic and diastolic blood pressure.
The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day.
This blood pressure monitor will be set to automatically take blood pressure every 20 minutes.
The monitor records and saves each blood pressure measurement automatically.
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Baseline racial comparison
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Blood pressure reactivity
Time Frame: Baseline racial comparison
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The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger.
Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise.
Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
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Baseline racial comparison
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Objective sleep duration and quality
Time Frame: Baseline racial comparison
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Philips actiwatch spectrum will be used to quantify sleep duration.
Participants will wear the watch units for 7 days.
The investigators will cross-check actigraphy wear times with a sleep diary.
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Baseline racial comparison
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Subjective sleep quality
Time Frame: Baseline racial comparison
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The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to asses sleep duration and perceived sleep quality reflective of the one month period leading into the study.
The PSQI global score has a possible range of 0-21 points.
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Baseline racial comparison
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Circulating reactive oxygen species
Time Frame: Baseline racial comparison
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The investigators will use electron paramagnetic resonance to measure reactive oxygen species (spectra units) in whole blood samples treated with a spin probe.
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Baseline racial comparison
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Blood biomarkers of nitric oxide bioavailability
Time Frame: Baseline racial comparison
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The investigators will measure nitric oxide metabolites (nitrate and nitrite nanomolar concentration) using chemiluminescence
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Baseline racial comparison
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Physical activity
Time Frame: Baseline racial comparison
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Participants will wear an ActiGraph GT3X accelerometer for seven days to objectively quantify steps per day and metabolic equivalents per day.
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Baseline racial comparison
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Mental health - social anxiety
Time Frame: Baseline racial comparison
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The investigators will administer the Liebowitz Social Anxiety Scale.
The scale starts at 0 (none) and ends at 3 (severe) for 24 questions related to anxiety and avoidance, and a cumulative score is calculated.
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Baseline racial comparison
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Mental health - depression
Time Frame: Baseline racial comparison
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The investigators will administer the Beck's Depression Inventory.
The scale starts at 0 and ends at 3 for 21 questions related to depression.
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Baseline racial comparison
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Neighborhood disadvantage
Time Frame: Baseline racial comparison
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The investigators will ask participants to identify their home addresses with investigator assistance and Google maps and potential assistance from their guardians or parents during early- and mid-childhood and adolescence.
The investigators will use the participant's address and census tract information to determine measures of neighborhood quality such as median income, crime rates, and median education level.
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Baseline racial comparison
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Habitual dietary intake
Time Frame: Baseline racial comparison
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The investigators will instruct participants to complete a diet log for 5 days which will be operationalized with Nutrition Data System for Research (NDSR).
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Baseline racial comparison
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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24-hour urine electrolytes
Time Frame: Baseline racial comparison
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The investigators will use an electrolyte analyzer to assess sodium, potassium, and chloride concentration.
The investigators will use urine volume and electrolyte concentration to determine 24-hour electrolyte excretion
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Baseline racial comparison
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Austin T Robinson, PhD, Auburn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jeong S, Linder BA, Barnett AM, Tharpe MA, Hutchison ZJ, Culver MN, Sanchez SO, Nichols OI, Grosicki GJ, Bunsawat K, Nasci VL, Gohar EY, Fuller-Rowell TE, Robinson AT. Interplay of Race and Neighborhood Deprivation on Resting and Ambulatory Blood Pressure in Young Adults. Am J Physiol Heart Circ Physiol. 2024 Jul 12. doi: 10.1152/ajpheart.00726.2023. Online ahead of print.
- Robinson AT, Linder BA, Barnett AM, Jeong S, Sanchez SO, Nichols OI, McIntosh MC, Hutchison ZJ, Tharpe MA, Watso JC, Gutierrez OM, Fuller-Rowell TE. Cross-sectional analysis of racial differences in hydration and neighborhood deprivation in young adults. Am J Clin Nutr. 2023 Oct;118(4):822-833. doi: 10.1016/j.ajcnut.2023.08.005. Epub 2023 Aug 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2020
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
September 19, 2020
First Submitted That Met QC Criteria
September 29, 2020
First Posted (Actual)
October 6, 2020
Study Record Updates
Last Update Posted (Actual)
August 13, 2024
Last Update Submitted That Met QC Criteria
August 12, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AU IRB #20-262 FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
IPD Sharing Time Frame
Following study completion, indefinitely
IPD Sharing Access Criteria
Upon reasonable request such as request to collaborate, performing a meta-analysis, or determine reliability, data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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