- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014348
Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
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
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie Marah, R.N.
- Phone Number: (301) 640-1701
- Email: marie.marah@nih.gov
Study Contact Backup
- Name: Tiffany M Powell-Wiley, M.D.
- Phone Number: (301) 594-3735
- Email: powelltm2@mail.nih.gov
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Female
Diagnostic
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- Principal Investigator: Tiffany M Powell-Wiley, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 190120
- 19-H-0120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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