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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05541653
Other study ID # 850178
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 29, 2022
Est. completion date May 2025

Study information

Verified date July 2023
Source University of Pennsylvania
Contact Evan Spencer, MS
Phone 215-327-4981
Email evan.spencer@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Financial Well-being Interventions
Tax preparation; access to public benefits; financial counseling and microgrants
Place-based Interventions
Vacant lot greening; abandoned house remediation; trash cleanup; and tree planting.

Locations

Country Name City State
United States Philadelphia Neighborhoods Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 24 months
Primary Psychological Distress Kessler-6 (answers scored 0-24 with higher scores indicating higher levels of psychological distress) 24 months
Secondary Overall health Rating of overall health (5-pt Likert ranging from poor to excellent) (Oregon Health Insurance Experiment) 24 months
Secondary Poor health Whether individual reported either poor or fair health to overall health question (Oregon Health Insurance Experiment) 24 months
Secondary Change in overall health Rating of how health has changed in last 6 months (better, same, worse) 24 months
Secondary Healthy days Number of days in the last 30 where physical or mental health precluded engagement in usual activities (self-care, work, recreation) 24 months
Secondary Sleep duration Number of hours of usual sleep (Behavioral Risk Factor Surveillance System) 24 months
Secondary Short sleep Less than seven hours of usual night sleep (Behavioral Risk Factor Surveillance System) 24 months
Secondary Healthcare access Received all needed care in the last 6 months (Behavioral Risk Factor Surveillance System) 24 months
Secondary Financial well-being Consumer Financial Protection Bureau, Abbreviated Financial Well-being Survey 24 months
Secondary Food insecurity Current Population Survey Food Security Supplement Screener 24 months
Secondary 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) 24 months
Secondary Home ownership Whether or not individual owns house, condo, or mobile home (Add Health) 24 months
Secondary Owing on mortgage Whether or not individual has remaining mortgage payments (internally developed) 24 months
Secondary Total debt Amount of debt added altogether, not including mortgage (Add Health) 24 months
Secondary 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) 24 months
Secondary Participation in public food benefit programs Participation of a household member (including respondent) in SNAP, WIC, Senior Food Box, other, or none (internally developed) 24 months
Secondary 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) 24 months
Secondary 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) 24 months
Secondary 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) 24 months
Secondary Time spent in greenspace Time spent in a greenspace on a typical day (adapted from Evenson et al 2013 Environment and Behavior)) 24 months
Secondary 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) 24 months
Secondary Perception of tree cover Beliefs about number of trees in the neighborhood (internally developed) 24 months
Secondary Tree planting concerns Whether or not individual has concerns about planting more trees in neighborhood (internally developed) 24 months
Secondary 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) 24 months
Secondary Perceived stress Perceived Stress Scale (responses scored 0-16 with higher scores correlated to higher stress) 24 months
Secondary 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) 24 months
Secondary 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). 24 months
Secondary Physical disorder Whether or not participant reports a lot of abandoned buildings in their neighborhood (Ross and Mirowksi) 24 months
Secondary Neighborhood crime rates Number of violent crimes, serious crimes Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) after intervention period complete
Secondary Nuisance calls Number of 311 calls Quarterly data from 24 months (8 quarters) prior to enrollment and 12 months (4 quarters) after intervention period complete
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