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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Metabolic Health
• Intervention / Treatment: Other: Greenness as a therapeutic intervention

• Study Type: Interventional
• Enrollment (Estimated): 835
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jackie Research Coordinator, MS; Phone Number: 502-852-6167; Email: jacqueline.gallagher@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Jackie Gallagher, MS; Phone Number: 502-852-6167; Email: jacqueline.gallagher@louisville.edu
      • Principal Investigator: Rachel Keith, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No intervention
Experimental: Targeted neighborhoods for Greenness; 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; Greenness to be used as a therapeutic intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: National Institute of Environmental Health Sciences (NIEHS); The Nature Conservancy
• Investigators: Study Director: Aruni Bhatnagar, PhD, University of Louisville; Principal Investigator: Rachel Keith, PhD, University of Louisville

Publications and helpful links

General Publications

• McLeish AC, Smith T, Riggs DW, Hart JL, Walker KL, Keith RJ, Anderson L, Sithu I, Pinilla-Baquero J, Srivastava S, Bhatnagar A. Community-Based Evaluation of the Associations Between Well-Being and Cardiovascular Disease Risk. J Am Heart Assoc. 2022 Nov 15;11(22):e027095. doi: 10.1161/JAHA.122.027095. Epub 2022 Nov 12.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 15.1260; R01ES029846-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No