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

NCT04014348 | Recruiting

• 2 other identifiers: 19012019-H-0120
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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, 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

Conditions

Cardiovascular (CV) Risk

Keywords

Neighborhood Environment; Cardiovascular Disease Risk; Social Determinants of Health; Diagnostic Behavioral study; Socio-Economic; Natural History

Outcome Measures

Primary Outcomes (1)

• Stress-related neural activity

  Stress-related neural activity will be estimated by neuroimaging (18-FDG PET/CT amygdala activity)

  1 month

Secondary Outcomes (1)

• 1) examine associations between neighborhood environment conditions

  1 month

Study Arms (1)

Female

Diagnostic

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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 \[BMI\].

You may qualify if:

• Individuals eligible for this protocol:
• 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)
• Must be between 19 to 45 years of age
• Must not have any chronic health condition (i.e.: cardiovascular, autoimmune, endocrinologic), or active infection
• Must be living in Washington, DC
• Must have access to a smartphone
• Must be able to provide informed consent
• Must speak English.

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Tiffany M Powell-Wiley, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Marah, R.N.

CONTACT

(301) 640-1701; marie.marah@nih.gov

Tiffany M Powell-Wiley, M.D.

CONTACT

(301) 594-3735; powelltm2@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 10, 2019
• Study Start: October 20, 2021
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06-03

Locations

US (1)