- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06925373
Housing, Environment, And Living Conditions for Transformed Health (HEALTHe)
Housing, Environment, And Living Conditions for Transformed Health (HEALTHe Birmingham)
This project will compare the health effects of public housing renovation, neighborhood built and social environment improvements, and indoor air purification, alone and in combination, as well as the cost effectiveness of each approach.
STUDY 1: The study will assess the effects of public housing and neighborhood environment (built and social) improvements on health-related behaviors, psychosocial and physiologic stress, and self-reported and physiological markers of lung health and chronic disease.
STUDY 2: The study will determine whether indoor air purification can positively impact lung health in public housing sites not undergoing housing renovation, comparing a site near industrial pollution vs one less contaminated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gabriela R Oates, PhD
- Phone Number: 205-996-5689
- Email: goates@uab.edu
Study Contact Backup
- Name: Joy R Ledvina, Program Director, MBA
- Phone Number: 205-975-7852
- Email: jrledvina@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Recruiting
- UAB Lung Health Center
-
Contact:
- Sonya Hardy, Clinical Research Regulatory Coordinator, MA
- Phone Number: 2059346685
- Email: sonyahardy@uabmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults age 18 years and older
- English speaking
- Residents of one of 4 public housing site in Birmingham, Alabama
Exclusion Criteria:
- Individuals who are not 18 years or older
- Do not speak English
- Do not meet the residency criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Elyton Village Community
Participants will receive improved neighborhood environment (built and social) and indoor air purification.
|
An indoor air purifier with a dual HEPA/activated carbon filter, a usage tracker, and an indoor air quality monitor will be installed in public housing residences.
Other Names:
Improved built environment (green space, sidewalks, street lights) and social environment (educational and workforce development programs, wrap-around social services, Internet access).
|
|
Active Comparator: Southtown Court Community
Participants will receive new public housing.
|
High-quality public housing
|
|
Active Comparator: Smithfield Court Community
Participants will receive new public housing and improved neighborhood environment (built and social).
|
Improved built environment (green space, sidewalks, street lights) and social environment (educational and workforce development programs, wrap-around social services, Internet access).
High-quality public housing
|
|
Active Comparator: Collegeville Community
Participants will receive indoor air purification.
|
An indoor air purifier with a dual HEPA/activated carbon filter, a usage tracker, and an indoor air quality monitor will be installed in public housing residences.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Indoor Air Quality
Time Frame: Baseline, 6 months, 12 months (Study 2 only)
|
Particulate matter (PM2.5).
Measures particles in the air that are 2.5 micrometers or smaller in diameter.
|
Baseline, 6 months, 12 months (Study 2 only)
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health
Time Frame: Baseline, 12 months, 24 months
|
A self-reported measure of physical, mental, and social health.
10 item questionnaire T-score metric from zero to 100 where higher T-scores indicate better health.
|
Baseline, 12 months, 24 months
|
|
Change in Allostatic load
Time Frame: Baseline, 12 months
|
Measure of cumulative stress burden as the number of 10 indicators above a threshold: (1) serum albumin <3.8 g/dL, (2) C Reactive Protein (CRP) >3 mg/L, (3) High-Density Lipoprotein (HDL) <40 mg/dL, (4) total cholesterol ≥240 mg/dL, (5) heart rate ≥90 beats/min, (6) systolic Blood Pressure (BP) ≥140 mmHg, (7) diastolic BP ≥90 mmHg, (8) serum creatinine ≥1.3 mg/dL, (9) Blood Urea Nitrogen (BUN) ≥18 mg/dL, and (10) waist circumference >88 cm in women, >102 cm in men.
|
Baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The percentage change in FEV1/FVC
Time Frame: Baseline, 6 months, 12 months (Study 2 only)
|
FEV1/FVC.
A measure of lung funtion that compares the amount of air exhaled in the first second (FEV1) to the total amount of air exhaled in a forced breath (FVC).
|
Baseline, 6 months, 12 months (Study 2 only)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gabriela R Oates, PhD, University of Alabama at Birmingham (UAB)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300013400
- 1U01NR021591 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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