Recruiting

Observational Study

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT04014348

Conditions

Cardiovascular (CV) Risk

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT04014348

Start date

Oct 20, 2021

Status verified date

Jun 3, 2026

Completion date

Dec 26, 2026

Anticipated

Primary completion date

Dec 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 45

Healthy Volunteers: Accepted

  • 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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Female

Diagnostic

Primary outcome measure

  • Stress-related neural activity [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Marie Marah, R.N.

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

Tiffany M Powell-Wiley, M.D.

(301) 496-5817powelltm2@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Aug 28, 2026

Last verified

Jun 3, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-08-28.