Clinical trial NCT03670524: Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project
Official title: Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Health
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
name: The Nature Conservancy
First posted: 2018-09-13
Enrollment: 835
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A unique pragmatic interventional trial with longitudinal follow up to assess the cardiovascular effects of increasing residential greenery.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup.
timeFrame: Baseline and 2 year followup
Secondary outcomes:
measure: Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.
timeFrame: Baseline and 2 year followup
measure: Physical Exam
timeFrame: Baseline and 2 year followup
measure: Body lean mass
timeFrame: Baseline and 2 year followup
measure: Body fat
timeFrame: Baseline and 2 year followup
measure: Standing height
timeFrame: Baseline and 2 year followup
measure: Waist, Hip measurement
timeFrame: Baseline and 2 year followup
measure: Respiratory status will be evaluated
timeFrame: Baseline and 2 year followup
measure: Bucchal swab
timeFrame: Baseline and 2 year followup
measure: Urine collection
timeFrame: Baseline and 2 year followup
measure: Lipids
timeFrame: Baseline and 2 year followup
measure: Toenail samples
timeFrame: Baseline and 2 year followup
measure: Hair samples
timeFrame: Baseline and 2 year followup
measure: Perceived stress scale-PSS-10 range 0-40
timeFrame: Baseline and 2 year followup
measure: Depression-Patient Health Questionnaire (PHQ-9) 0-27
timeFrame: Baseline and 2 year followup
measure: Well-being assessment-Questionnaire 13-65
timeFrame: Baseline and 2 year followup
measure: Health perception
timeFrame: Baseline and 2 year followup
measure: National Health Interview Survey tobacco questionnaire
timeFrame: Baseline and 2 year followup
measure: The Alcohol Use disorders identification test (AUDIT)- Range 0-40
timeFrame: Baseline and 2 year followup
measure: Self reported physical activity 1
timeFrame: Baseline and 2 year followup
measure: Self reported physical activity 2
timeFrame: Baseline and 2 year followup
measure: Self reported education
timeFrame: Baseline and 2 year followup
measure: Self reported annual income
timeFrame: Baseline and 2 year followup
measure: Platelet count
timeFrame: Baseline and 2 year followup
measure: Complete Blood Count 1
timeFrame: Baseline and 2 year followup
measure: Complete Blood Count 2
timeFrame: Baseline and 2 year followup
measure: Complete Blood Count 3
timeFrame: Baseline and 2 year followup
measure: Liver function
timeFrame: Baseline and 2 year followup
measure: C-Reactive Protein
timeFrame: Baseline and 2 year followup
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Aruni Bhatnagar, PhD
role: STUDY_DIRECTOR
affiliation: University of Louisville
name: Rachel Keith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.