What this study is
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 details
- Official title
- Pilot Study for Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Cardiovascular (CV) Risk
- Enrolling
- 250 people
- Starts
- 2021-10-20
- Est. completion
- 2026-12-26
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 19 Years – 45 YearsSex FEMALEHealthy volunteers AcceptedYou 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 can't join 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY8664111010prpl@cc.nih.gov
Recruiting
Study team
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID 190120
Principal investigator
Tiffany M Powell-Wiley, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.