Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project

Study Overview
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Brief Summary
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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.

Official Title
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Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project

Conditions
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Cardiovascular Diseases, Metabolic Health

Intervention / Treatment
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* Other: Greenness as a therapeutic intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A unique pragmatic interventional trial with longitudinal follow up to assess the cardiovascular effects of increasing residential greenery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted neighborhoods for Greenness<br>Using greenness as a therapeutic intervention, we will plant shrubs, grasses, young and mature trees (40-50 ft in height), so that we can evaluate changes in health and pollution, 2 years after planting. | Other: Greenness as a therapeutic intervention<br>* Greenness to be used as a therapeutic intervention<br>|
| No Intervention: Control Group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup. | Blood pressure mm Hg | Baseline and 2 year followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup. | Augmentation index-percent | Baseline and 2 year followup | 
| Physical Exam | Body weight-pounds | Baseline and 2 year followup | 
| Body lean mass | Body lean mass to be measured in pounds | Baseline and 2 year followup | 
| Body fat | Body fat to be measured in percentage | Baseline and 2 year followup | 
| Standing height | standing height reported in inches | Baseline and 2 year followup | 
| Waist, Hip measurement | central adiposity (waist circumference, and hip circumference to be measured in inches | Baseline and 2 year followup | 
| Respiratory status will be evaluated | Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages | Baseline and 2 year followup | 
| Bucchal swab | Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping. | Baseline and 2 year followup | 
| Urine collection | metabolites of environmental volatile organic compounds ng/mg creatinine, biogenic VOCs and nicotine metabolites ng/mg creatinine, catecholamines ng/mg creatinine | Baseline and 2 year followup | 
| Lipids | LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl | Baseline and 2 year followup | 
| Toenail samples | Toenail samples to look for heavy metal exposure | Baseline and 2 year followup | 
| Hair samples | Hair samples to look at cortisol levels over time. | Baseline and 2 year followup | 
| Perceived stress scale-PSS-10 range 0-40 | The higher the score the more perceived stress | Baseline and 2 year followup | 
| Depression-Patient Health Questionnaire (PHQ-9) 0-27 | 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. | Baseline and 2 year followup | 
| Well-being assessment-Questionnaire 13-65 | Warwick-Edinburgh Mental Well-being scale 13-65. The higher the score the higher the sense of well-being. | Baseline and 2 year followup | 
| Health perception | Health perception questionnaire | Baseline and 2 year followup | 
| National Health Interview Survey tobacco questionnaire | National Health Interview Survey tobacco questionnaire | Baseline and 2 year followup | 
| The Alcohol Use disorders identification test (AUDIT)- Range 0-40 | 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. | Baseline and 2 year followup | 
| Self reported physical activity 1 | times per week | Baseline and 2 year followup | 
| Self reported physical activity 2 | Exertion level of mild moderate or vigorous | Baseline and 2 year followup | 
| Self reported education | Education to be reported by last school grade completed | Baseline and 2 year followup | 
| Self reported annual income | Annual income reported by dollars | Baseline and 2 year followup | 
| Platelet count | cells/cubic millimeter | Baseline and 2 year followup | 
| Complete Blood Count 1 | White/Red blood cell count- cells per cubic millimeter | Baseline and 2 year followup | 
| Complete Blood Count 2 | Hemoglobin-grams/deciliter | Baseline and 2 year followup | 
| Complete Blood Count 3 | Hematocrit-percentage | Baseline and 2 year followup | 
| Liver function | AST, ALT units per liter | Baseline and 2 year followup | 
| C-Reactive Protein | Hs-CRP-mg/Liter | Baseline and 2 year followup |