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

Cardiovascular Diseases Clinical Trial

— HEAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03670524
• Other study ID #: 15.1260
• Secondary ID: R01ES029846-01
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: October 30, 2026

Study information

• Verified date: November 2023
• Source: University of Louisville
• Contact: Jackie Research Coordinator, MS
• Phone: 502-852-6167
• Email: jacqueline.gallagher[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 835
• Est. completion date: October 30, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Health

Intervention

Other:
• Greenness as a therapeutic intervention
Greenness to be used as a therapeutic intervention

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
University of Louisville	National Institute of Environmental Health Sciences (NIEHS), The Nature Conservancy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.	Augmentation index-percent	Baseline and 2 year followup
Secondary	Physical Exam	Body weight-pounds	Baseline and 2 year followup
Secondary	Body lean mass	Body lean mass to be measured in pounds	Baseline and 2 year followup
Secondary	Body fat	Body fat to be measured in percentage	Baseline and 2 year followup
Secondary	Standing height	standing height reported in inches	Baseline and 2 year followup
Secondary	Waist, Hip measurement	central adiposity (waist circumference, and hip circumference to be measured in inches	Baseline and 2 year followup
Secondary	Respiratory status will be evaluated	Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages	Baseline and 2 year followup
Secondary	Bucchal swab	Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping.	Baseline and 2 year followup
Secondary	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
Secondary	Lipids	LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl	Baseline and 2 year followup
Secondary	Toenail samples	Toenail samples to look for heavy metal exposure	Baseline and 2 year followup
Secondary	Hair samples	Hair samples to look at cortisol levels over time.	Baseline and 2 year followup
Secondary	Perceived stress scale-PSS-10 range 0-40	The higher the score the more perceived stress	Baseline and 2 year followup
Secondary	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
Secondary	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
Secondary	Health perception	Health perception questionnaire	Baseline and 2 year followup
Secondary	National Health Interview Survey tobacco questionnaire	National Health Interview Survey tobacco questionnaire	Baseline and 2 year followup
Secondary	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
Secondary	Self reported physical activity 1	times per week	Baseline and 2 year followup
Secondary	Self reported physical activity 2	Exertion level of mild moderate or vigorous	Baseline and 2 year followup
Secondary	Self reported education	Education to be reported by last school grade completed	Baseline and 2 year followup
Secondary	Self reported annual income	Annual income reported by dollars	Baseline and 2 year followup
Secondary	Platelet count	cells/cubic millimeter	Baseline and 2 year followup
Secondary	Complete Blood Count 1	White/Red blood cell count- cells per cubic millimeter	Baseline and 2 year followup
Secondary	Complete Blood Count 2	Hemoglobin-grams/deciliter	Baseline and 2 year followup
Secondary	Complete Blood Count 3	Hematocrit-percentage	Baseline and 2 year followup
Secondary	Liver function	AST, ALT units per liter	Baseline and 2 year followup
Secondary	C-Reactive Protein	Hs-CRP-mg/Liter	Baseline and 2 year followup