Recruiting NCT03670524
Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Greenness as a therapeutic intervention.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Metabolic Health. Basic parameters: 30 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Greenness as a therapeutic intervention
Greenness to be used as a therapeutic intervention
Primary outcome measures
- Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup. [Time frame: Baseline and 2 year followup]
Secondary outcome measures (12)
- Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup. [Time frame: Baseline and 2 year followup]
- Physical Exam [Time frame: Baseline and 2 year followup]
- Body lean mass [Time frame: Baseline and 2 year followup]
- Body fat [Time frame: Baseline and 2 year followup]
- Standing height [Time frame: Baseline and 2 year followup]
- Waist, Hip measurement [Time frame: Baseline and 2 year followup]
- Respiratory status will be evaluated [Time frame: Baseline and 2 year followup]
- Bucchal swab [Time frame: Baseline and 2 year followup]
- Urine collection [Time frame: Baseline and 2 year followup]
- Lipids [Time frame: Baseline and 2 year followup]
- Toenail samples [Time frame: Baseline and 2 year followup]
- Hair samples [Time frame: Baseline and 2 year followup]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Louisville — Louisville
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. PMID 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. PMID 36370026
Identifiers
NCT: NCT03670524 · 15.1260 · R01ES029846-01