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

May 28, 2026 updated by: National Heart, Lung, and Blood Institute (NHLBI)

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

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, who have access to a smartphone

Design:

Participants may stay at the NIH Clinical Center overnight for a 2-day visit.

Visit 1 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

Nutrition consultation

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.

Visit 2-

Device return

Nutritional consultation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 high socio-economic status neighborhoods and low socioeconomic status neighborhoods 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Contact:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Phone Number: TTY8664111010 800-411-1222
          • Email: prpl@cc.nih.gov

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Recruitment will take place at both the NIH Clinical Center and at the NHLBI Hope Center. The proposed study will be cross-sectional with a sample of healthy White females (n=30) and healthy Black females of African descent (n=30) 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 the high SES census tracts within Washington, DC. The other participants (n=30) will be recruited from low SES census tracts in Washington DC. Finally, participants from high and low SES census tracts in Washington DC will be matched with respect to age, race, and body mass index [BMI].

Description

  • INCLUSION CRITERIA:

Individuals eligible for this protocol:

  1. A healthy self-identified White female (i.e. self-identifies as White or of European descent) or healthy Black female (i.e. self-identifies as Black, African American, or of African descent)
  2. Must be between 19 to 45 years of age
  3. Must not have any chronic health condition (i.e.: cardiovascular, autoimmune, endocrinologic), or active infection
  4. Must be living in Washington, DC
  5. Must have access to a smartphone
  6. Must be able to provide informed consent
  7. Must speak English.

EXCLUSION CRITERIA:

  1. Pregnant or breast feeding
  2. Physically unable to perform physical activity for any reason
  3. Subject had weight changes greater than 20% over the past 3 months
  4. Subject is obese by our measurements (BMI greater than or equal to 35.0 kg/m^2)
  5. If you have high or low blood pressure requiring medications
  6. Diabetes
  7. History of severe mental illnesses, treated with hospitalization
  8. If you have evidence of active thyroid disease requiring medications
  9. If you are taking medication for chronic non-mental health related illness (ie: cardiovascular, autoimmune, endocrinologic)
  10. If you have food allergies or highly restrictive diets that may prevent your ability to consume a controlled metabolic diet.
  11. If you are a current smoker (tobacco products)

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Female
Diagnostic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stress-related neural activity
Time Frame: 1 month
Stress-related neural activity will be estimated by neuroimaging (18-FDG PET/CT amygdala activity)
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1) examine associations between neighborhood environment conditions
Time Frame: 1 month
rate of poverty, disorder, crime through both residential neighborhoods and individuals activity space and differences in cardiovascular risk and immune activation through: (i) assessment of vascular function (vascular stiffness, vascular inflammation); and (ii) measures of immune function (i.e. flow cytometry for immune cell phenotyping
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tiffany M Powell-Wiley, M.D., National Heart, Lung, and Blood Institute (NHLBI)

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 8, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 190120
  • 19-H-0120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

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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