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Trial record 2 of 3467 for:    Louisville

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

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ClinicalTrials.gov Identifier: NCT03670524
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
National Institute of Environmental Health Sciences (NIEHS)
The Nature Conservancy
Information provided by (Responsible Party):
Rachel Keith, University of Louisville

Brief 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 cohesion.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Metabolic Health Other: Greenness as a therapeutic intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A unique pragmatic interventional trial with longitudinal follow up to assess the cardiovascular effects of increasing residential greenery.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 30, 2020

Arm Intervention/treatment
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

No Intervention: Control Group
No intervention



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup. [ Time Frame: Baseline and 2 year followup ]
    Augmentation index-percent

  2. Physical Exam [ Time Frame: Baseline and 2 year followup ]
    Body weight-pounds

  3. Body lean mass [ Time Frame: Baseline and 2 year followup ]
    Body lean mass to be measured in pounds

  4. Body fat [ Time Frame: Baseline and 2 year followup ]
    Body fat to be measured in percentage

  5. Standing height [ Time Frame: Baseline and 2 year followup ]
    standing height reported in inches

  6. Waist, Hip measurement [ Time Frame: Baseline and 2 year followup ]
    central adiposity (waist circumference, and hip circumference to be measured in inches

  7. Respiratory status will be evaluated [ Time Frame: Baseline and 2 year followup ]
    Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages

  8. Bucchal swab [ Time Frame: Baseline and 2 year followup ]
    Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping.

  9. Urine collection [ Time Frame: Baseline and 2 year followup ]
    Multiple markers of exposure including metabolites of environmental volatile organic compounds, biogenic VOCs and nicotine metabolites as well as stress catecholamines.

  10. Lipids [ Time Frame: Baseline and 2 year followup ]
    LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl

  11. Toenail samples [ Time Frame: Baseline and 2 year followup ]
    Toenail samples to look for heavy metal exposure

  12. Hair samples [ Time Frame: Baseline and 2 year followup ]
    Hair samples to look at cortisol levels over time.

  13. Perceived stress scale-PSS-10 range 0-40 [ Time Frame: Baseline and 2 year followup ]
    The higher the score the more perceived stress

  14. 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.

  15. 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.

  16. Occupational exposure [ Time Frame: Baseline and 2 year followup ]
    Occupational exposure questionnaire

  17. Health perception [ Time Frame: Baseline and 2 year followup ]
    Health perception questionnaire

  18. Perceived neighborhood cohesion [ Time Frame: Baseline and 2 year followup ]
    Perceived neighborhood cohesion questionnaire

  19. National Health Interview Survey tobacco questionnaire [ Time Frame: Baseline and 2 year followup ]
    National Health Interview Survey tobacco questionnaire

  20. 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.

  21. Self reported physical activity [ Time Frame: Baseline and 2 year followup ]
    times per week and exertion level of mild moderate or vigorous

  22. Self reported education [ Time Frame: Baseline and 2 year followup ]
    Education to be reported by last school grade completed

  23. Self reported annual income [ Time Frame: Baseline and 2 year followup ]
    Annual income reported by dollars

  24. Medical history [ Time Frame: Baseline and 2 year followup ]
    Medical history questionnaire

  25. Platelet count [ Time Frame: Baseline and 2 year followup ]
    cells/cubic millimeter

  26. Complete Blood Count [ Time Frame: Baseline and 2 year followup ]
    White/Red blood cell count- cells per cubic millimeter, Hemoglobin-grams/deciliter, Hematocrit-percentage

  27. Liver function [ Time Frame: Baseline and 2 year followup ]
    AST, ALT units per liter

  28. C-Reactive Protein [ Time Frame: Baseline and 2 year followup ]
    Hs-CRP-mg/Liter



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670524


Contacts
Contact: Jessica Clinical Research Coordinator 502-852-4236 jessica.nystoriak@louisville.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jessica Clinical Research Coordinator         
Sub-Investigator: Rachel Keith, PhD         
Sponsors and Collaborators
University of Louisville
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

Responsible Party: Rachel Keith, Asst Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT03670524     History of Changes
Other Study ID Numbers: 15.1260
R01ES029846-01 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cardiovascular Diseases