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Cardiovascular DiseasesHEALNCT03670524

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

A study testing Greenness as a therapeutic intervention in people with Cardiovascular Diseases and Metabolic Health, run by University of Louisville at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Metabolic Health
What is being tested?
Greenness as a therapeutic intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
835 participants
Where
1 siteUnited States
Study dates
3 May 2018to 30 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 30-70 years of age.
  • Live within the targeted study location

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jackie Research Coordinator, MS contact

502-852-6167

jacqueline.gallagher@louisville.edu

United States1 site, 1 recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Jackie Gallagher, MS, 502-852-6167, jacqueline.gallagher@louisville.edu

    Rachel Keith, PhD

    Recruiting

Other trials in United States

About this study

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.

Being tested
Greenness as a therapeutic intervention
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Greenness as a therapeutic interventionOther

    Greenness to be used as a therapeutic intervention

Study groups in NCT03670524
Study groupRoleWhat they receive
Targeted neighborhoods for GreennessExperimentalUsing 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.
Receives: Other: Greenness as a therapeutic intervention
Control GroupNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.

    Augmentation index-percent

    Measured: Baseline and 2 year followup

Secondary outcomes (28)

  1. Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup.

    Blood pressure mm Hg

    Measured: Baseline and 2 year followup

  2. Physical Exam

    Body weight-pounds

    Measured: Baseline and 2 year followup

  3. Body lean mass

    Body lean mass to be measured in pounds

    Measured: Baseline and 2 year followup

  4. Body fat

    Body fat to be measured in percentage

    Measured: Baseline and 2 year followup

  5. Standing height

    standing height reported in inches

    Measured: Baseline and 2 year followup

  6. Waist, Hip measurement

    central adiposity (waist circumference, and hip circumference to be measured in inches

    Measured: Baseline and 2 year followup

  7. Respiratory status will be evaluated

    Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages

    Measured: Baseline and 2 year followup

  8. Bucchal swab

    Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping.

    Measured: Baseline and 2 year followup

  9. Urine collection

    metabolites of environmental volatile organic compounds ng/mg creatinine, biogenic VOCs and nicotine metabolites ng/mg creatinine, catecholamines ng/mg creatinine

    Measured: Baseline and 2 year followup

  10. Lipids

    LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl

    Measured: Baseline and 2 year followup

  11. Toenail samples

    Toenail samples to look for heavy metal exposure

    Measured: Baseline and 2 year followup

  12. Hair samples

    Hair samples to look at cortisol levels over time.

    Measured: Baseline and 2 year followup

  13. Perceived stress scale-PSS-10 range 0-40

    The higher the score the more perceived stress

    Measured: Baseline and 2 year followup

  14. 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.

    Measured: Baseline and 2 year followup

  15. 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.

    Measured: Baseline and 2 year followup

  16. Health perception

    Health perception questionnaire

    Measured: Baseline and 2 year followup

  17. National Health Interview Survey tobacco questionnaire

    National Health Interview Survey tobacco questionnaire

    Measured: Baseline and 2 year followup

  18. 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.

    Measured: Baseline and 2 year followup

  19. Self reported physical activity 1

    times per week

    Measured: Baseline and 2 year followup

  20. Self reported physical activity 2

    Exertion level of mild moderate or vigorous

    Measured: Baseline and 2 year followup

  21. Self reported education

    Education to be reported by last school grade completed

    Measured: Baseline and 2 year followup

  22. Self reported annual income

    Annual income reported by dollars

    Measured: Baseline and 2 year followup

  23. Platelet count

    cells/cubic millimeter

    Measured: Baseline and 2 year followup

  24. Complete Blood Count 1

    White/Red blood cell count- cells per cubic millimeter

    Measured: Baseline and 2 year followup

  25. Complete Blood Count 2

    Hemoglobin-grams/deciliter

    Measured: Baseline and 2 year followup

  26. Complete Blood Count 3

    Hematocrit-percentage

    Measured: Baseline and 2 year followup

  27. Liver function

    AST, ALT units per liter

    Measured: Baseline and 2 year followup

  28. C-Reactive Protein

    Hs-CRP-mg/Liter

    Measured: Baseline and 2 year followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2018
  2. Study start3 May 2018
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A unique pragmatic interventional trial with longitudinal follow up to assess the cardiovascular effects of increasing residential greenery.
Masking
None (open label)
Enrolment
835 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670524
Sponsor's protocol ID
15.1260
Other IDs
R01ES029846-01
Acronym
HEAL
Status last verified
Feb 2026
First submitted
31 Aug 2018
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bhatnagar A, Keith R, Yeager R, Riggs D, Sears C, Bucknum B, Smith T, Fleischer D, Chandler C, Walker KL, Hart JL, Srivastava S, Turner J, Rai S. The Green Heart Project: objectives, design, and methods. Am J Epidemiol. 2026 May 7;195(5):1416-1428. doi: 10.1093/aje/kwae458.

    PubMed 39691946

  • 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.

    PubMed 36370026

Questions about this trial

What is this clinical trial studying?

A study testing Greenness as a therapeutic intervention in people with Cardiovascular Diseases and Metabolic Health, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jackie Research Coordinator, MS (502-852-6167, jacqueline.gallagher@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup. (time frame: Baseline and 2 year followup). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03670524, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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