Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04014348|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : August 19, 2019
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.
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.
Healthy white or black females ages 19 45 who live in Washington, DC, wards 3 or 5 and have access to a smartphone
Participants will stay at the NIH Clinical Center overnight for a 2-day visit. Tests will include:
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.
Body size measurements
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.
Participants will then have a follow-up visit. They will have blood tests and take surveys.
|Condition or disease|
|Cardiovascular (CV) Risk|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Pilot Study for Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women|
|Estimated Study Start Date :||August 22, 2019|
|Estimated Primary Completion Date :||December 10, 2019|
|Estimated Study Completion Date :||December 7, 2020|
- Stress-related neural activity [ Time Frame: 1 month ]Stress-related neural activity will be estimated by neuroimaging (18-FDG PET/CTamygdala activity)
- Cardiovascular risks and immune activation [ Time Frame: 2 weeks ]Several measures of cardiovascular risk and immune activation will be performed including: (i) assessment of vascular function (vascular stiffness, vascular inflammation) and (ii) measures of immune function (i.e. flow cytometry for immune cell phenotyping, cytokine/chemokine/cortisol/neurotransmitter profiling, lipidomic analyses for lipid inflammatory intermediates, PBMC telomere length, methylation patterns, RNAseq analysis)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014348
|Contact: Valerie Morales-Mitchelll||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Not yet recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Tiffany M Powell-Wiley, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|