Cardiovascular Diseases, Metabolic Health
Conditions
Brief summary
The purpose of this study is to examine how the environment and neighborhood characteristics affects the health of the area residents. The study will help determine how changing neighborhood characteristics, such as green space, affect heart health, risk factors for other diseases, sense of well- being or neighborhood cohesion.
Interventions
OTHERGreenness as a therapeutic intervention
Greenness to be used as a therapeutic intervention
Sponsors
University of Louisville
National Institute of Environmental Health Sciences (NIEHS)
The Nature Conservancy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A unique pragmatic interventional trial with longitudinal follow up to assess the cardiovascular effects of increasing residential greenery.
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 30-70 years of age. * Live within the targeted study location
Exclusion criteria
* Unwilling or unable to provide consent. * HIV/AIDS, active treatment for cancer, active bleeding including wounds. * Body weight less than 100 pounds or BMI\>40. * Prisoners and other vulnerable populations. * Anyone that PI thinks is unsafe to participate in study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup. | Baseline and 2 year followup | Augmentation index-percent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self reported annual income | Baseline and 2 year followup | Annual income reported by dollars |
| Platelet count | Baseline and 2 year followup | cells/cubic millimeter |
| Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup. | Baseline and 2 year followup | Blood pressure mm Hg |
| Physical Exam | Baseline and 2 year followup | Body weight-pounds |
| Body lean mass | Baseline and 2 year followup | Body lean mass to be measured in pounds |
| Body fat | Baseline and 2 year followup | Body fat to be measured in percentage |
| Standing height | Baseline and 2 year followup | standing height reported in inches |
| Waist, Hip measurement | Baseline and 2 year followup | central adiposity (waist circumference, and hip circumference to be measured in inches |
| Respiratory status will be evaluated | Baseline and 2 year followup | Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages |
| Bucchal swab | Baseline and 2 year followup | Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping. |
| Urine collection | Baseline and 2 year followup | metabolites of environmental volatile organic compounds ng/mg creatinine, biogenic VOCs and nicotine metabolites ng/mg creatinine, catecholamines ng/mg creatinine |
| Lipids | Baseline and 2 year followup | LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl |
| Toenail samples | Baseline and 2 year followup | Toenail samples to look for heavy metal exposure |
| Hair samples | Baseline and 2 year followup | Hair samples to look at cortisol levels over time. |
| Perceived stress scale-PSS-10 range 0-40 | Baseline and 2 year followup | The higher the score the more perceived stress |
| Depression-Patient Health Questionnaire (PHQ-9) 0-27 | Baseline and 2 year followup | The 0-4= none; 5-9= Mild, 10-14= Moderate; 15-19= moderately severe; 20-27= severe. The higher the score the more severe the depression. |
| Well-being assessment-Questionnaire 13-65 | Baseline and 2 year followup | Warwick-Edinburgh Mental Well-being scale 13-65. The higher the score the higher the sense of well-being. |
| Health perception | Baseline and 2 year followup | Health perception questionnaire |
| National Health Interview Survey tobacco questionnaire | Baseline and 2 year followup | National Health Interview Survey tobacco questionnaire |
| The Alcohol Use disorders identification test (AUDIT)- Range 0-40 | Baseline and 2 year followup | Scores of 8-15 or more are recommended indicators of hazardous and harmful alcohol use or possible alcohol dependence. Women can be lowered to a score of 7 for concern. Scores of 16-19 suggest a need for brief counseling and continues monitoring. Scores of 20 or above warrant diagnostic evaluation for alcohol dependence. |
| Self reported physical activity 1 | Baseline and 2 year followup | times per week |
| Self reported physical activity 2 | Baseline and 2 year followup | Exertion level of mild moderate or vigorous |
| Complete Blood Count 1 | Baseline and 2 year followup | White/Red blood cell count- cells per cubic millimeter |
| Complete Blood Count 2 | Baseline and 2 year followup | Hemoglobin-grams/deciliter |
| Complete Blood Count 3 | Baseline and 2 year followup | Hematocrit-percentage |
| Liver function | Baseline and 2 year followup | AST, ALT units per liter |
| Self reported education | Baseline and 2 year followup | Education to be reported by last school grade completed |
| C-Reactive Protein | Baseline and 2 year followup | Hs-CRP-mg/Liter |
Countries
United States
Contacts
CONTACTJackie Research Coordinator, MS
STUDY_DIRECTORAruni Bhatnagar, PhD
University of Louisville
PRINCIPAL_INVESTIGATORRachel Keith, PhD
University of Louisville
Outcome results
None listed