University of Louisville
Louisville, Kentucky, 40202, United States
Location status: Recruiting
Location contact
Jackie Gallagher, MS
CONTACT
Rachel Keith, PhD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT03670524
Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
30 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Greenness as a therapeutic intervention
OtherGreenness to be used as a therapeutic intervention
Primary outcomes
-
Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.
Time frame: Baseline and 2 year followup
Augmentation index-percent
Secondary outcomes
-
Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup.
Time frame: Baseline and 2 year followup
Blood pressure mm Hg
-
Physical Exam
Time frame: Baseline and 2 year followup
Body weight-pounds
-
Body lean mass
Time frame: Baseline and 2 year followup
Body lean mass to be measured in pounds
-
Body fat
Time frame: Baseline and 2 year followup
Body fat to be measured in percentage
-
Standing height
Time frame: Baseline and 2 year followup
standing height reported in inches
-
Waist, Hip measurement
Time frame: Baseline and 2 year followup
central adiposity (waist circumference, and hip circumference to be measured in inches
-
Respiratory status will be evaluated
Time frame: Baseline and 2 year followup
Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages
-
Bucchal swab
Time frame: Baseline and 2 year followup
Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping.
-
Urine collection
Time frame: 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
Time frame: Baseline and 2 year followup
LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl
-
Toenail samples
Time frame: Baseline and 2 year followup
Toenail samples to look for heavy metal exposure
-
Hair samples
Time frame: Baseline and 2 year followup
Hair samples to look at cortisol levels over time.
-
Perceived stress scale-PSS-10 range 0-40
Time frame: Baseline and 2 year followup
The higher the score the more perceived stress
-
Depression-Patient Health Questionnaire (PHQ-9) 0-27
Time frame: 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
Time frame: 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
Time frame: Baseline and 2 year followup
Health perception questionnaire
-
National Health Interview Survey tobacco questionnaire
Time frame: Baseline and 2 year followup
National Health Interview Survey tobacco questionnaire
-
The Alcohol Use disorders identification test (AUDIT)- Range 0-40
Time frame: 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
Time frame: Baseline and 2 year followup
times per week
-
Self reported physical activity 2
Time frame: Baseline and 2 year followup
Exertion level of mild moderate or vigorous
-
Self reported education
Time frame: Baseline and 2 year followup
Education to be reported by last school grade completed
-
Self reported annual income
Time frame: Baseline and 2 year followup
Annual income reported by dollars
-
Platelet count
Time frame: Baseline and 2 year followup
cells/cubic millimeter
-
Complete Blood Count 1
Time frame: Baseline and 2 year followup
White/Red blood cell count- cells per cubic millimeter
-
Complete Blood Count 2
Time frame: Baseline and 2 year followup
Hemoglobin-grams/deciliter
-
Complete Blood Count 3
Time frame: Baseline and 2 year followup
Hematocrit-percentage
-
Liver function
Time frame: Baseline and 2 year followup
AST, ALT units per liter
-
C-Reactive Protein
Time frame: Baseline and 2 year followup
Hs-CRP-mg/Liter
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Louisville
Other
Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- The Nature Conservancy
Registry information
Acronym: HEAL
Important dates
- Study start
- 2018
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Sep 13, 2018
- Registry last updated
- Feb 10, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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