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

Not Applicable

Recruiting

• Conditions: Metabolic Health; Cardiovascular Diseases
• Interventions: Other: Greenness as a therapeutic intervention

• Registration Number: NCT03670524
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-03
• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 835

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted neighborhoods for Greenness	Greenness as a therapeutic intervention	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.

Primary Outcome Measures

Name	Time	Method
Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup.	Baseline and 2 year followup	Blood pressure mm Hg

Secondary Outcome Measures

Name	Time	Method
Self reported education	Baseline and 2 year followup	Education to be reported by last school grade completed
Self reported physical activity 1	Baseline and 2 year followup	times per week
Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.	Baseline and 2 year followup	Augmentation index-percent
Physical Exam	Baseline and 2 year followup	Body weight-pounds
Body fat	Baseline and 2 year followup	Body fat to be measured in percentage
Body lean mass	Baseline and 2 year followup	Body lean mass to be measured in pounds
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
Perceived stress scale-PSS-10 range 0-40	Baseline and 2 year followup	The higher the score the more perceived stress
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.
Hair samples	Baseline and 2 year followup	Hair samples to look at cortisol levels over time.
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.
Self reported physical activity 2	Baseline and 2 year followup	Exertion level of mild moderate or vigorous
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.
Platelet count	Baseline and 2 year followup	cells/cubic millimeter
Self reported annual income	Baseline and 2 year followup	Annual income reported by dollars
Complete Blood Count 2	Baseline and 2 year followup	Hemoglobin-grams/deciliter
Complete Blood Count 3	Baseline and 2 year followup	Hematocrit-percentage
Complete Blood Count 1	Baseline and 2 year followup	White/Red blood cell count- cells per cubic millimeter
Liver function	Baseline and 2 year followup	AST, ALT units per liter
C-Reactive Protein	Baseline and 2 year followup	Hs-CRP-mg/Liter

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States