- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541653
The IGNITE Study on Concentrated Investment in Black Neighborhoods
A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Black individuals in the United States fare worse than White individuals across almost every social, economic, and health indicator. The Black health disadvantage starts at birth, reflecting the cumulative toll of racialized social stressors and healthcare discrimination on maternal health and resulting in higher rates of preterm birth and low birth weight. Black youth are disproportionately exposed to environmental toxins such as lead and adverse childhood events such as financial hardship and neighborhood violence. Black adults have higher rates of chronic disease, including diabetes, hypertension, as well as many cancers. These and other forces culminate in a stark racial longevity gap: in Philadelphia, the location of this study, life expectancy for people living in a poor, predominantly Black neighborhood is 20 years lower than for people living in a nearby affluent, predominantly White neighborhood.
The fundamental cause of these striking and pervasive disparities is structural racism - the confluence of deep historical, institutional, cultural, and ideological forces that unequally distribute resources and risks across racialized groups. Structural racism patterns health by affecting a range of interconnected, mutually reinforcing social determinants of health at the national, neighborhood, household, and individual levels. Most notably, longstanding, systematic disinvestment has resulted in highly segregated Black neighborhoods with dilapidated environmental conditions and severe economic insecurity within Black households, leading to a "feedback loop of concentrated racial disadvantage," all of which have been strongly tied to poor health.
Most interventions seeking to address racial health disparities focus on individual-level behaviors and outcomes, or individual channels by which structural racism harms health. However, by failing to address upstream social determinants, these interventions have had limited population level impact. A multi-level, multi-component intervention package focused on a range of social determinants of health is necessary to meaningfully address structural racism as a fundamental cause of racial health disparities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 00000
- Philadelphia Neighborhoods
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 18 years of age
- Have the ability to communicate via text messaging
- Individuals comfortable communicating in English
- A permanent resident of the home where they are to be enrolled
- Have knowledge of their household finances
Exclusion Criteria:
- Individuals who plan to move out of the study microcluster within 6 months
- Individuals who are unable to fully consent and participate based on recruitment team assessment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
At the individual level, participants in the intervention arm receive place-based and financial well-being interventions. These include, at the individual level:
At the neighborhood level:
|
Tax preparation; access to public benefits; financial counseling and microgrants
Vacant lot greening; abandoned house remediation; trash cleanup; and tree planting.
|
|
No Intervention: Control
Participants in the control arm will not receive any of the listed interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Health Index
Time Frame: 24 months
|
Composite index using method of Anderson (2008) based on three questions: rating of overall health (5-pt Likert ranging from poor to excellent); rating of how health has changed in last 6 months (better, same, worse); and number of days in the last 30 where physical or mental health precluded engagement in usual activities (self-care, work, recreation); (Oregon Health Insurance Experiment)
|
24 months
|
|
Psychological Distress
Time Frame: 24 months
|
Kessler-6 (answers scored 0-24 with higher scores indicating higher levels of psychological distress)
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall health
Time Frame: 24 months
|
Rating of overall health (5-pt Likert ranging from poor to excellent) (Oregon Health Insurance Experiment)
|
24 months
|
|
Poor health
Time Frame: 24 months
|
Whether individual reported either poor or fair health to overall health question (Oregon Health Insurance Experiment)
|
24 months
|
|
Change in overall health
Time Frame: 24 months
|
Rating of how health has changed in last 6 months (better, same, worse)
|
24 months
|
|
Healthy days
Time Frame: 24 months
|
Number of days in the last 30 where physical or mental health precluded engagement in usual activities (self-care, work, recreation)
|
24 months
|
|
Sleep duration
Time Frame: 24 months
|
Number of hours of usual sleep (Behavioral Risk Factor Surveillance System)
|
24 months
|
|
Short sleep
Time Frame: 24 months
|
Less than seven hours of usual night sleep (Behavioral Risk Factor Surveillance System)
|
24 months
|
|
Healthcare access
Time Frame: 24 months
|
Received all needed care in the last 6 months (Behavioral Risk Factor Surveillance System)
|
24 months
|
|
Financial well-being
Time Frame: 24 months
|
Consumer Financial Protection Bureau, Abbreviated Financial Well-being Survey
|
24 months
|
|
Food insecurity
Time Frame: 24 months
|
Current Population Survey Food Security Supplement Screener
|
24 months
|
|
Income tax filing
Time Frame: 24 months
|
Whether or not individual (or someone in household on behalf of individual) filed previous years income tax (yes, planning to file late, no) (internally developed)
|
24 months
|
|
Home ownership
Time Frame: 24 months
|
Whether or not individual owns house, condo, or mobile home (Add Health)
|
24 months
|
|
Owing on mortgage
Time Frame: 24 months
|
Whether or not individual has remaining mortgage payments (internally developed)
|
24 months
|
|
Total debt
Time Frame: 24 months
|
Amount of debt added altogether, not including mortgage (Add Health)
|
24 months
|
|
Participation in public medical benefit programs
Time Frame: 24 months
|
Participation of a household member (including respondent) in Medicaid, Medicare, Medicare savings, LIS, CHIP, Qualified Health Plans, SelectPlan, other, or none (internally developed)
|
24 months
|
|
Participation in public food benefit programs
Time Frame: 24 months
|
Participation of a household member (including respondent) in SNAP, WIC, Senior Food Box, other, or none (internally developed)
|
24 months
|
|
Participation in public income support or cash benefit programs
Time Frame: 24 months
|
Participation of a household member (including respondent) in TANF, LIHEAP, SSI/SSDI, UI, PA General Assistance, PA Emergency Rental Assistance, EITC, CTC Refugee Cash Assistance, CCIS, PA Child Care Tax Credit, other, or none (internally developed)
|
24 months
|
|
Participation in public home ownership benefit programs
Time Frame: 24 months
|
Participation of a household member (including respondent) in PTRR, Homestead Exemption, LOOP, Basic Systems Repair Program, PA Homeowner Assistance, Philly First Home Program, Philadelphia Home Repair Assistance, other or none (internally developed)
|
24 months
|
|
Frequency of greenspace engagment
Time Frame: 24 months
|
Frequency with which individual visits a greenspace (such as a park, garden, greened vacant lot, trail, or any other outdoor space with vegetation) (adapted from Evenson et al 2013 Environment and Behavior)
|
24 months
|
|
Time spent in greenspace
Time Frame: 24 months
|
Time spent in a greenspace on a typical day (adapted from Evenson et al 2013 Environment and Behavior))
|
24 months
|
|
Reasons for not spending time in greenspace
Time Frame: 24 months
|
Things that stop an individual from spending time in greenspace (adapted from Evenson et al 2013 Environment and Behavior)
|
24 months
|
|
Perception of tree cover
Time Frame: 24 months
|
Beliefs about number of trees in the neighborhood (internally developed)
|
24 months
|
|
Tree planting concerns
Time Frame: 24 months
|
Whether or not individual has concerns about planting more trees in neighborhood (internally developed)
|
24 months
|
|
Perceived tree health benefits
Time Frame: 24 months
|
Whether or not individual believes trees confer health benefits (e.g., safety, mental health benefits, physical health benefits, social benefits, environmental benefits, aesthetic benefits)
|
24 months
|
|
Perceived stress
Time Frame: 24 months
|
Perceived Stress Scale (responses scored 0-16 with higher scores correlated to higher stress)
|
24 months
|
|
Time spent in neighborhood
Time Frame: 24 months
|
Frequency with which individual endorses spending time relaxing, socializing, or hanging out in porches, stoops, and front yards of neighborhoods (adapted from Kahneman et al 2004 Science)
|
24 months
|
|
Neighborhood social capital
Time Frame: 24 months
|
Neighborhood Social Cohesion & Exchange and Social & Physical Disorder Scale (two domains: Social Cohesion and Physical Disorder.
Higher scores for social cohesion indicate higher levels of social cohesion and higher scores for physical disorder indicate higher levels of physical disorder).
|
24 months
|
|
Physical disorder
Time Frame: 24 months
|
Whether or not participant reports a lot of abandoned buildings in their neighborhood (Ross and Mirowksi)
|
24 months
|
|
Neighborhood crime rates
Time Frame: Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) after intervention period complete
|
Overall number of crimes, number of violent crimes, serious crimes, and gun related incidents
|
Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) after intervention period complete
|
|
Nuisance calls
Time Frame: Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) after intervention period complete
|
Number of 311 calls and number of 311 calls for neighborhood cleanup and remediation-related issues
|
Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) after intervention period complete
|
Collaborators and Investigators
Sponsor
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 850178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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