Financial StressNCT05541653
The IGNITE Study on Concentrated Investment in Black Neighborhoods
A study testing Financial Well-being Interventions and Place-based Interventions in people with Financial Stress and Economic Problems, run by University of Pennsylvania at 1 site in United States.
Trial summary
Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Financial Stress, Economic Problems, Environmental Exposure
- What is being tested?
- Financial Well-being Interventions and Place-based Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 571 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Neighborhoods
Philadelphia, Pennsylvania, 00000
About this study
Official title: A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Health
Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place-based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood microclusters, with a total of 720 adults. The investigators hypothesize that this "big push" intervention will have significant impact on overall health and wellbeing.
Read the 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.
- Conditions
- Financial Stress, Economic Problems, Environmental Exposure, Health Behavior, Health, Subjective, Mental Health Wellness 1
- Being tested
- Financial Well-being Interventions, Place-based Interventions
- Medical subject headings
- Financial Stress, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Well-being InterventionsOther
Tax preparation; access to public benefits; financial counseling and microgrants
Place-based InterventionsOther
Vacant lot greening; abandoned house remediation; trash cleanup; and tree planting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | At the individual level, participants in the intervention arm receive place-based and financial well-being interventions.
These include, at the individual level:
* Tax preparation
* Access to public benefits
* Financial counseling and microgrants
At the neighborhood level:
* Abandoned house remediation
* Trash cleanup
* Vacant lot greening
* Tree planting Receives: Other: Financial Well-being Interventions; Other: Place-based Interventions |
| Control | No intervention | Participants in the control arm will not receive any of the listed interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Health Index
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)
Measured: 24 months
Psychological Distress
Kessler-6 (answers scored 0-24 with higher scores indicating higher levels of psychological distress)
Measured: 24 months
Secondary outcomes (32)
Overall health
Rating of overall health (5-pt Likert ranging from poor to excellent) (Oregon Health Insurance Experiment)
Measured: 24 months
Poor health
Whether individual reported either poor or fair health to overall health question (Oregon Health Insurance Experiment)
Measured: 24 months
Change in overall health
Rating of how health has changed in last 6 months (better, same, worse)
Measured: 24 months
Healthy days
Number of days in the last 30 where physical or mental health precluded engagement in usual activities (self-care, work, recreation)
Measured: 24 months
Sleep duration
Number of hours of usual sleep (Behavioral Risk Factor Surveillance System)
Measured: 24 months
Short sleep
Less than seven hours of usual night sleep (Behavioral Risk Factor Surveillance System)
Measured: 24 months
Healthcare access
Received all needed care in the last 6 months (Behavioral Risk Factor Surveillance System)
Measured: 24 months
Financial well-being
Consumer Financial Protection Bureau, Abbreviated Financial Well-being Survey
Measured: 24 months
Food insecurity
Current Population Survey Food Security Supplement Screener
Measured: 24 months
Income tax filing
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)
Measured: 24 months
Home ownership
Whether or not individual owns house, condo, or mobile home (Add Health)
Measured: 24 months
Owing on mortgage
Whether or not individual has remaining mortgage payments (internally developed)
Measured: 24 months
Total debt
Amount of debt added altogether, not including mortgage (Add Health)
Measured: 24 months
Participation in public medical benefit programs
Participation of a household member (including respondent) in Medicaid, Medicare, Medicare savings, LIS, CHIP, Qualified Health Plans, SelectPlan, other, or none (internally developed)
Measured: 24 months
Participation in public food benefit programs
Participation of a household member (including respondent) in SNAP, WIC, Senior Food Box, other, or none (internally developed)
Measured: 24 months
Participation in public income support or cash benefit programs
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)
Measured: 24 months
Participation in public home ownership benefit programs
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)
Measured: 24 months
Frequency of greenspace engagment
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)
Measured: 24 months
Time spent in greenspace
Time spent in a greenspace on a typical day (adapted from Evenson et al 2013 Environment and Behavior))
Measured: 24 months
Reasons for not spending time in greenspace
Things that stop an individual from spending time in greenspace (adapted from Evenson et al 2013 Environment and Behavior)
Measured: 24 months
Perception of tree cover
Beliefs about number of trees in the neighborhood (internally developed)
Measured: 24 months
Tree planting concerns
Whether or not individual has concerns about planting more trees in neighborhood (internally developed)
Measured: 24 months
Perceived tree health benefits
Whether or not individual believes trees confer health benefits (e.g., safety, mental health benefits, physical health benefits, social benefits, environmental benefits, aesthetic benefits)
Measured: 24 months
Perceived stress
Perceived Stress Scale (responses scored 0-16 with higher scores correlated to higher stress)
Measured: 24 months
Time spent in neighborhood
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)
Measured: 24 months
Neighborhood social capital
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).
Measured: 24 months
Physical disorder
Whether or not participant reports a lot of abandoned buildings in their neighborhood (Ross and Mirowksi)
Measured: 24 months
Neighborhood crime rates
Overall number of crimes, number of violent crimes, serious crimes, and gun related incidents
Measured: Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) post study completion
Nuisance calls
Number of 311 calls and number of 311 calls for neighborhood cleanup and remediation-related issues
Measured: Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) post study completion
Hospitalizations
Number of Hospitalizations
Measured: Quarterly/monthly data from 8 quarters/24 months prior to enrollment and at the completion of enrollment
Emergency department (ED) visits
Number of ED visits
Measured: Quarterly/monthly data from 8 quarters/24 months prior to enrollment and at the completion of enrollment
Ambulatory visits
Number of ambulatory visits
Measured: Quarterly/monthly data from 8 quarters/24 months prior to enrollment and at the completion of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start29 Sep 2022
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial StressStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 571 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugenia Garvin, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541653
- Sponsor's protocol ID
- 850178
- Status last verified
- Feb 2026
- First submitted
- 2 Sep 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Health
- ClinicalTrials.gov ID
- NCT05541653
- Acronym / sponsor ID
- 850178
- Conditions
- Financial Stress, Economic Problems, Environmental Exposure, Health Behavior, Health, Subjective, Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 571 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place-based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood microclusters, with a total of 720 adults. The investigators hypothesize that this "big push" intervention will have significant impact on overall health and wellbeing.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Financial Well-being Interventions, Other: Place-based InterventionsAt the individual level, participants in the intervention arm receive place-based and financial well-being interventions. These include, at the individual level: * Tax preparation * Access to public benefits * Financial counseling and microgrants At the neighborhood level: * Abandoned house remediation * Trash cleanup * Vacant lot greening * Tree planting |
| Control | No intervention | –Participants in the control arm will not receive any of the listed interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Well-being InterventionsTax preparation; access to public benefits; financial counseling and microgrants | Other | Intervention |
| Place-based InterventionsVacant lot greening; abandoned house remediation; trash cleanup; and tree planting. | Other | Intervention |
Primary outcome
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)
Psychological Distress
Time frame: 24 months
Kessler-6 (answers scored 0-24 with higher scores indicating higher levels of psychological distress)
32 secondary outcomes
Overall health
Time frame: 24 months
Poor health
Time frame: 24 months
Change in overall health
Time frame: 24 months
Healthy days
Time frame: 24 months
Sleep duration
Time frame: 24 months
Short sleep
Time frame: 24 months
Healthcare access
Time frame: 24 months
Financial well-being
Time frame: 24 months
Food insecurity
Time frame: 24 months
Income tax filing
Time frame: 24 months
Home ownership
Time frame: 24 months
Owing on mortgage
Time frame: 24 months
Total debt
Time frame: 24 months
Participation in public medical benefit programs
Time frame: 24 months
Participation in public food benefit programs
Time frame: 24 months
Participation in public income support or cash benefit programs
Time frame: 24 months
Participation in public home ownership benefit programs
Time frame: 24 months
Frequency of greenspace engagment
Time frame: 24 months
Time spent in greenspace
Time frame: 24 months
Reasons for not spending time in greenspace
Time frame: 24 months
Perception of tree cover
Time frame: 24 months
Tree planting concerns
Time frame: 24 months
Perceived tree health benefits
Time frame: 24 months
Perceived stress
Time frame: 24 months
Time spent in neighborhood
Time frame: 24 months
Neighborhood social capital
Time frame: 24 months
Physical disorder
Time frame: 24 months
Neighborhood crime rates
Time frame: Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) post study completion
Nuisance calls
Time frame: Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) post study completion
Hospitalizations
Time frame: Quarterly/monthly data from 8 quarters/24 months prior to enrollment and at the completion of enrollment
Emergency department (ED) visits
Time frame: Quarterly/monthly data from 8 quarters/24 months prior to enrollment and at the completion of enrollment
Ambulatory visits
Time frame: Quarterly/monthly data from 8 quarters/24 months prior to enrollment and at the completion of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Well-being Interventions and Place-based Interventions in people with Financial Stress and Economic Problems, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Health Index (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.