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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03670524
Other study ID # 15.1260
Secondary ID R01ES029846-01
Status Recruiting
Phase N/A
First received
Last updated
Start date May 3, 2018
Est. completion date October 30, 2026

Study information

Verified date November 2023
Source University of Louisville
Contact Jackie Research Coordinator, MS
Phone 502-852-6167
Email jacqueline.gallagher@louisville.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 cohesion.


Recruitment information / eligibility

Status Recruiting
Enrollment 835
Est. completion date October 30, 2026
Est. primary completion date October 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Greenness as a therapeutic intervention
Greenness to be used as a therapeutic intervention

Locations

Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (3)

Lead Sponsor Collaborator
University of Louisville National Institute of Environmental Health Sciences (NIEHS), The Nature Conservancy

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup. Augmentation index-percent Baseline and 2 year followup
Secondary Physical Exam Body weight-pounds Baseline and 2 year followup
Secondary Body lean mass Body lean mass to be measured in pounds Baseline and 2 year followup
Secondary Body fat Body fat to be measured in percentage Baseline and 2 year followup
Secondary Standing height standing height reported in inches Baseline and 2 year followup
Secondary Waist, Hip measurement central adiposity (waist circumference, and hip circumference to be measured in inches Baseline and 2 year followup
Secondary Respiratory status will be evaluated Fleisch-type pneumotachometer used to evaluate FEV1 and FVC percentages Baseline and 2 year followup
Secondary Bucchal swab Assess oral microbiome and DNA from cheek swab will be stored for genetic phenotyping. Baseline and 2 year followup
Secondary 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
Secondary Lipids LDL-mg/dl, HDL-mg/dl, total cholesterol-mg/dl Baseline and 2 year followup
Secondary Toenail samples Toenail samples to look for heavy metal exposure Baseline and 2 year followup
Secondary Hair samples Hair samples to look at cortisol levels over time. Baseline and 2 year followup
Secondary Perceived stress scale-PSS-10 range 0-40 The higher the score the more perceived stress Baseline and 2 year followup
Secondary 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
Secondary 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
Secondary Health perception Health perception questionnaire Baseline and 2 year followup
Secondary National Health Interview Survey tobacco questionnaire National Health Interview Survey tobacco questionnaire Baseline and 2 year followup
Secondary 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
Secondary Self reported physical activity 1 times per week Baseline and 2 year followup
Secondary Self reported physical activity 2 Exertion level of mild moderate or vigorous Baseline and 2 year followup
Secondary Self reported education Education to be reported by last school grade completed Baseline and 2 year followup
Secondary Self reported annual income Annual income reported by dollars Baseline and 2 year followup
Secondary Platelet count cells/cubic millimeter Baseline and 2 year followup
Secondary Complete Blood Count 1 White/Red blood cell count- cells per cubic millimeter Baseline and 2 year followup
Secondary Complete Blood Count 2 Hemoglobin-grams/deciliter Baseline and 2 year followup
Secondary Complete Blood Count 3 Hematocrit-percentage Baseline and 2 year followup
Secondary Liver function AST, ALT units per liter Baseline and 2 year followup
Secondary C-Reactive Protein Hs-CRP-mg/Liter Baseline and 2 year followup
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