Protocol Details
Pilot Study for Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
This study is currently recruiting participants.
Summary
Number | 19-H-0120 |
Sponsoring Institute | National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Female
Min Age: 19 Years
Max Age: 45 Years |
Referral Letter Required | No |
Population Exclusion(s) | Native Hawaiian/Pacific Islander;
Hispanic or Latino;
Asian;
American Indian or Alaskan Native;
Non-English Speaking;
Children;
Male |
Keywords | Neighborhood Environment;
Cardiovascular Disease Risk;
Social Determinants of Health;
Diagnostic Behavioral study;
Socio-Economic;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Cardiovascular (CV) Risk |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Heart, Lung, and Blood Institute |
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
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)
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT04014348