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Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women

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ClinicalTrials.gov Identifier: NCT04014348
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

Heart disease is a leading cause of death in the United States. Healthy diet and exercise improve heart health. Some features of where a person lives can lead to stress and decrease chances for exercise. Researchers want to see how these factors may increase the risk of heart disease in women.

Objective:

To see if there are differences in stress levels between women who live in different parts of Washington, DC. Also, to see how these women use their neighborhoods for exercise.

Eligibility:

Healthy white or black females ages 19 45 who live in Washington, DC, wards 3 or 5 and have access to a smartphone

Design:

Participants will stay at the NIH Clinical Center overnight for a 2-day visit. Tests will include:

Physical exam

Blood tests

Electrocardiogram: Electrodes on the participant s skin will measure heart activity.

PET/CT scan: Participants will get an injection. They will lie in a machine that takes pictures of the body.

Surveys

Body size measurements

Blood vessel tests: This is measured with blood pressure cuffs, a device placed on the participant s fingertip, and a probe placed on the participant s neck.

Resting Energy Expenditure: Participants will breathe under a clear hood for 45 minutes.

Participants will be followed for about 2 weeks. They will wear a device on the wrist and carry a GPS device. Through a mobile app, they will answer short daily surveys on stress and exercise.

Participants will then have a follow-up visit. They will have blood tests and take surveys.


Condition or disease
Cardiovascular (CV) Risk

Detailed Description:
Innovative analyses of cardiovascular (CV) risk markers and heath behaviors in relation to neighborhood stressors are needed to further elucidate mechanisms by which adverse neighborhood conditions lead to poor CV outcomes. We propose to objectively measure physical activity, sedentary behavior, and neighborhood stress through accelerometers, global positioning systems (GPS), and ecological momentary assessment survey (via smartphone survey), linked to biological measures in a sample of White and African American women in Washington, D.C. neighborhoods. We hypothesize that individuals who are living in worse neighborhood environment conditions (e.g., higher poverty, crime, and social disorder) will be associated with higher chronic stress-related neural activity. As a secondary hypothesis, we hypothesize that associations between living in socio-economically disadvantaged neighborhood conditions and adverse biological markers will be moderated/mediated through levels of physical activity, time spent on sedentary activities, and dietary intake. Relationships between living in socio-economically disadvantaged neighborhood conditions and adverse biological markers will be also be mediated through psychosocial factors. In Aim 1, we will test associations between neighborhood environment conditions (e.g., poverty, crime, social disorder) and differences in stress-related neural activity, using PET CT-measured amygdala FDG uptake among a sample of White and African American women in Ward 3 (higher socioeconomic status neighborhood) and Ward 5 (low-to-middle socio-economic status neighborhood) in Washington D.C. In Aim 2a, we will determine associations between neighborhood environment conditions (e.g., poverty, crime, social disorder) and differences in cardiovascular risk and immune activation. Several measures of cardiovascular risk and immune activation will be performed including: (i) assessment of vascular function (vascular stiffness, vascular inflammation) and (ii) measures of immune function (i.e. flow cytometry for immune cell phenotyping, cytokine/chemokine/cortisol/neurotransmitter profiling, lipidomic analyses for lipid inflammatory intermediates, PBMC telomere length). In Aim 2b, we will assess feasibility and practicality of the use of geospatial tools and methods for measuring environmental factors (i.e. poverty, crime, social disorder) among this sample of women in Washington, DC. In aim 2c, we will examine whether associations between worse neighborhood environment conditions and adverse biological markers may be moderated and/or mediated by health behaviors (i.e., physical activity, sedentary time, dietary intake) and psychosocial factors (i.e., mood) measured via ecological momentary assessment (EMA). This project has a strong potential for improving scientific understanding of how neighborhood stress may influence biological measures of stress-related neural activity, such as amygdala activity, to improve our knowledge on interrelations among biology, environment, and cardiovascular health.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pilot Study for Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
Estimated Study Start Date : August 22, 2019
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : December 7, 2020

Group/Cohort
Female
Diagnostic



Primary Outcome Measures :
  1. Stress-related neural activity [ Time Frame: 1 month ]
    Stress-related neural activity will be estimated by neuroimaging (18-FDG PET/CTamygdala activity)


Secondary Outcome Measures :
  1. Cardiovascular risks and immune activation [ Time Frame: 2 weeks ]
    Several measures of cardiovascular risk and immune activation will be performed including: (i) assessment of vascular function (vascular stiffness, vascular inflammation) and (ii) measures of immune function (i.e. flow cytometry for immune cell phenotyping, cytokine/chemokine/cortisol/neurotransmitter profiling, lipidomic analyses for lipid inflammatory intermediates, PBMC telomere length, methylation patterns, RNAseq analysis)



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The proposed study will be cross-sectional with a sample of healthy White females (n=30) and females of African descent Americans (n=30) from Wards 3 and 5 in Washington, DC. Participants will be asked to wear a GPS unit and accelerometer, and to use a smartphone (i.e., to measure perceived stress/mood via EMA) to examine associations between GIS-derived neighborhood variables, stress-related neural activity measures, and adverse biological markers. A sample of the women (n=30) will be recruited from high income areas in Ward 3. They will be recruited from census tracts within 5% range for median household income of Ward 3. The other participants (n=30) will be recruited from low income areas in Wards 5. They will also be recruited from census tracts within 5% range for median household income of Ward 5.
Criteria
  • INCLUSION CRITERIA:

Individuals eligible for this protocol:

  1. A healthy white female or healthy black female of African descent
  2. Must be between 19 to 45 years of age
  3. Must not have any chronic health condition, including lung disease or active infection
  4. Must be living in Washington, DC wards 3 or 5
  5. Must have access to a smartphone
  6. Must be able to provide informed consent
  7. Must speak English.

EXCLUSION CRITERIA:

  1. If you are pregnant or breast feeding
  2. If you are physically unable to perform physical activity for any reason
  3. If you have had weight changes greater than 20% over the past 3 months
  4. If you are obese by our measurements (BMI greater than or equal to 30.0 kg/m2)
  5. If you have high or low blood pressure
  6. If you have diabetes
  7. If you have a history of mental illnesses, treated with medication and therapy
  8. If you have a history or evidence of hyper/hypothyroidism
  9. If you are taking medication for chronic illness
  10. If you have HIV.
  11. If you have food allergies or highly restrictive diets that may prevent your ability to consume a controlled metabolic diet.
  12. If you are a smoker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014348


Contacts
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Contact: Valerie Morales-Mitchelll (301) 827-4981 valerie.mitchell@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Tiffany M Powell-Wiley, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT04014348     History of Changes
Other Study ID Numbers: 190120
19-H-0120
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: July 3, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Neighborhood Environment
Cardiovascular Disease Risk
Social Determinants of Health
Diagnostic Behavioral study
Socio-Economic