NCT03670524

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
835

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
31mo left

Started May 2018

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
May 2018Oct 2028

Study Start

First participant enrolled

May 3, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

9.4 years

First QC Date

August 31, 2018

Last Update Submit

February 6, 2026

Conditions

Metabolic HealthCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Pulse Wave Analysis. Assess change from baseline arterial stiffness measurement and 2 year followup.

    Augmentation index-percent

    Baseline and 2 year followup

Secondary Outcomes (28)

  • Cardiovascular Measurements. Change from Baseline Systolic and Diastolic pressures at baseline and 2 year followup.

    Baseline and 2 year followup

  • Physical Exam

    Baseline and 2 year followup

  • Body lean mass

    Baseline and 2 year followup

  • Body fat

    Baseline and 2 year followup

  • Standing height

    Baseline and 2 year followup

  • +23 more secondary outcomes

Study Arms (2)

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.

Other: Greenness as a therapeutic intervention

Control Group

NO INTERVENTION

No intervention

Interventions

Greenness as a therapeutic interventionOTHER

Greenness to be used as a therapeutic intervention

Targeted neighborhoods for Greenness

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age.
  • Live within the targeted study location

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (1)

  • 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: 36370026DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Aruni Bhatnagar, PhD

    University of Louisville

    STUDY DIRECTOR

  • Rachel Keith, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Research Coordinator, MS

CONTACT

502-852-6167jacqueline.gallagher@louisville.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A unique pragmatic interventional trial with longitudinal follow up to assess the cardiovascular effects of increasing residential greenery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 13, 2018

Study Start

May 3, 2018

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 30, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)