NCT04014348 Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
| NCT ID | NCT04014348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Cardiovascular (CV) Risk |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-10-20 |
| Primary Completion | 2026-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2021-10-20 with a primary completion date of 2026-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
* 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)
Contact & Investigator
Tiffany M Powell-Wiley, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT04014348 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 45 Years, studying Cardiovascular (CV) Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04014348 currently recruiting?
Yes, NCT04014348 is actively recruiting participants. Contact the research team at marie.marah@nih.gov for enrollment information.
Where is the NCT04014348 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04014348 clinical trial?
NCT04014348 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Tiffany M Powell-Wiley, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 250 participants.