NCT03670524RecruitingNot Applicable
Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Louisville
- Enrollment
- 835
- Locations
- 1
- Primary Endpoint
- Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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>
- •Prisoners and other vulnerable populations.
- •Anyone that PI thinks is unsafe to participate in study.
Arms & Interventions
Targeted neighborhoods for Greenness
Experimental
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.
Intervention: Greenness as a therapeutic intervention (Other)
Control Group
No Intervention
No intervention
Outcomes
Primary Outcomes
Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.
Time Frame: Baseline and 2 year followup
Augmentation index-percent
Secondary Outcomes
- Physical Exam(Baseline and 2 year followup)
- Body fat(Baseline and 2 year followup)
- Body lean mass(Baseline and 2 year followup)
- Standing height(Baseline and 2 year followup)
- Waist, Hip measurement(Baseline and 2 year followup)
- Respiratory status will be evaluated(Baseline and 2 year followup)
- Bucchal swab(Baseline and 2 year followup)
- Urine collection(Baseline and 2 year followup)
- Lipids(Baseline and 2 year followup)
- Toenail samples(Baseline and 2 year followup)
- Perceived stress scale-PSS-10 range 0-40(Baseline and 2 year followup)
- Well-being assessment-Questionnaire 13-65(Baseline and 2 year followup)
- Hair samples(Baseline and 2 year followup)
- Depression-Patient Health Questionnaire (PHQ-9) 0-27(Baseline and 2 year followup)
- Self reported physical activity 2(Baseline and 2 year followup)
- Health perception(Baseline and 2 year followup)
- National Health Interview Survey tobacco questionnaire(Baseline and 2 year followup)
- The Alcohol Use disorders identification test (AUDIT)- Range 0-40(Baseline and 2 year followup)
- Self reported physical activity 1(Baseline and 2 year followup)
- Self reported education(Baseline and 2 year followup)
- Platelet count(Baseline and 2 year followup)
- Self reported annual income(Baseline and 2 year followup)
- Complete Blood Count 2(Baseline and 2 year followup)
- Complete Blood Count 3(Baseline and 2 year followup)
- Complete Blood Count 1(Baseline and 2 year followup)
- Liver function(Baseline and 2 year followup)
- C-Reactive Protein(Baseline and 2 year followup)
- Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup.(Baseline and 2 year followup)
Investigators
Rachel Keith
Asst Professor
University of Louisville
Study Sites (1)
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