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

February 6, 2026 updated by: Rachel Keith, University of Louisville
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
835

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
        • Principal Investigator:
          • Rachel Keith, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.
Time Frame: Baseline and 2 year followup
Augmentation index-percent
Baseline and 2 year followup

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 2 year followup
Physical Exam
Time Frame: Baseline and 2 year followup
Body weight-pounds
Baseline and 2 year followup
Body lean mass
Time Frame: Baseline and 2 year followup
Body lean mass to be measured in pounds
Baseline and 2 year followup
Body fat
Time Frame: Baseline and 2 year followup
Body fat to be measured in percentage
Baseline and 2 year followup
Standing height
Time Frame: Baseline and 2 year followup
standing height reported in inches
Baseline and 2 year followup
Waist, Hip measurement
Time Frame: Baseline and 2 year followup
central adiposity (waist circumference, and hip circumference to be measured in inches
Baseline and 2 year followup
Respiratory status will be evaluated
Time Frame: Baseline and 2 year followup
Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages
Baseline and 2 year followup
Bucchal swab
Time Frame: Baseline and 2 year followup
Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping.
Baseline and 2 year followup
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
Baseline and 2 year followup
Lipids
Time Frame: Baseline and 2 year followup
LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl
Baseline and 2 year followup
Toenail samples
Time Frame: Baseline and 2 year followup
Toenail samples to look for heavy metal exposure
Baseline and 2 year followup
Hair samples
Time Frame: Baseline and 2 year followup
Hair samples to look at cortisol levels over time.
Baseline and 2 year followup
Perceived stress scale-PSS-10 range 0-40
Time Frame: Baseline and 2 year followup
The higher the score the more perceived stress
Baseline and 2 year followup
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.
Baseline and 2 year followup
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.
Baseline and 2 year followup
Health perception
Time Frame: Baseline and 2 year followup
Health perception questionnaire
Baseline and 2 year followup
National Health Interview Survey tobacco questionnaire
Time Frame: Baseline and 2 year followup
National Health Interview Survey tobacco questionnaire
Baseline and 2 year followup
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.
Baseline and 2 year followup
Self reported physical activity 1
Time Frame: Baseline and 2 year followup
times per week
Baseline and 2 year followup
Self reported physical activity 2
Time Frame: Baseline and 2 year followup
Exertion level of mild moderate or vigorous
Baseline and 2 year followup
Self reported education
Time Frame: Baseline and 2 year followup
Education to be reported by last school grade completed
Baseline and 2 year followup
Self reported annual income
Time Frame: Baseline and 2 year followup
Annual income reported by dollars
Baseline and 2 year followup
Platelet count
Time Frame: Baseline and 2 year followup
cells/cubic millimeter
Baseline and 2 year followup
Complete Blood Count 1
Time Frame: Baseline and 2 year followup
White/Red blood cell count- cells per cubic millimeter
Baseline and 2 year followup
Complete Blood Count 2
Time Frame: Baseline and 2 year followup
Hemoglobin-grams/deciliter
Baseline and 2 year followup
Complete Blood Count 3
Time Frame: Baseline and 2 year followup
Hematocrit-percentage
Baseline and 2 year followup
Liver function
Time Frame: Baseline and 2 year followup
AST, ALT units per liter
Baseline and 2 year followup
C-Reactive Protein
Time Frame: Baseline and 2 year followup
Hs-CRP-mg/Liter
Baseline and 2 year followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Louisville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Environmental Health Sciences (NIEHS)
The Nature Conservancy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Aruni Bhatnagar, PhD, University of Louisville
  • Principal Investigator: Rachel Keith, PhD, University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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