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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG034546-14 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this pilot clinical trial is to learn about the effects of a short-term unconditional cash transfer (UCT) in people living with poverty and chronic disease (either prediabetes/diabetes or hypertension). The main questions it aims to answer are:
Participants will complete surveys and health measurements at two timepoints 3 months apart. Half of the participants will be randomly assigned to the treatment where they will receive a UCT of $1000 over 4 months. Researchers will compare the treatment group to the control group to see if there are improvements in health risk factors directly related to insufficient resources (food and utility security, stress-levels, mental bandwidth), financial outcomes, and health behaviors.
Health behaviors are major, modifiable risk factors for the development and progression of chronic diseases, which account for a large proportion of all deaths in the US and contribute to disparities in premature mortality based on both income and race. There is substantial evidence, for example, that behaviors like smoking, physical inactivity, and unhealthy diet are associated with an increased risk of cardiovascular disease (CVD), as are modifiable factors such as blood pressure, cholesterol, body mass index, and fasting glucose. A growing body of research suggests that poverty may affect health behaviors through financial and psychological pathways. However, few studies have rigorously examined the effects of poverty alleviation interventions on health behaviors, particularly among individuals at high risk for CVD. Even fewer studies have examined potential psychological mechanisms by which anti-poverty interventions might influence health behavior. This pilot project will examine the effect of unconditional cash transfers, an economic intervention that is gaining traction among policymakers, on risk factors for CVD and other chronic diseases. The project will focus on low-income adults in Philadelphia who have at least one health risk factor for CVD (diabetes/pre-diabetes and/or hypertension) and examines whether short-term, unconditional cash transfer payments result in changes in objective and self-reported health outcomes. The second aim examines potential psychological mechanisms through which the cash transfer intervention may affect study participants' behavior, including mental health, psychosocial stress, bandwidth, and future orientation. The third aim uses qualitative methods to understand participants' experiences with this study. The project activities will include developing and testing the cash transfer intervention (Stage 1) as well as basic science analysis of mechanisms of change (Stage 0).
Survey and measurement data will be collected from 100 participants at baseline and 3 month follow-up in a two-arm randomized controlled trial (50 in control, 50 in intervention). 16 participants will receive a blood pressure cuff to take home and send measurements weekly to assess the feasibility of at-home measurement (8 control, 8 intervention; half of each group will transmit wirelessly, the other half will not). 30 participants from the 3-month follow-up who are interested in doing an interview will provide additional qualitative data on their experience.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No intervention | |
| Cash Transfer | Experimental | Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cash Transfer | Behavioral | Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Food Security Category | Change from baseline in food security in the last 30 days as measured by the US Department of Agriculture food security scale. Outcome is 3 ordered categories: high or marginal food security, low food security, very low food security. | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Utility Security Category | Change from baseline in utility security in the last 3 months as measured by the Home Energy Insecurity scale. Outcome is 5 ordered categories: thriving, capable, stable, vulnerable, in-crisis. | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Financial Well-being Scale | Change from baseline in current financial well-being as measured by the Consumer Financial Protection Bureau Financial Well-Being 0-100 scale (higher scores are correlated to more well-being). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Perceived Stress Scale | Change from baseline in perceived stress in the last 30 days as measured by the Perceived Stress Scale (short form; 0-16, higher scores are correlated to more stress). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in State Anxiety Scale | Change from baseline in current anxiety as measured by the State Trait Anxiety Inventory subscale. The range is from 20-80 with lower scores meaning less anxiety. | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Mental Bandwidth | Change from baseline in number of lapses in the Psychomotor Vigilance Task (more lapses indicate less mental bandwidth). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Emergency Department Visits | We had initially hoped to descriptively summarize these outcomes as part of this pilot study, but the staff member leading our analyses departed during the course of this study and we no longer had someone with the skills and bandwidth to pull, merge, and analyze these data from the electronic health record. For that reason, the data were never collected in this sample and so we have not reported these outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Richterman, MD, MPH | University of Pennsylvania | Principal Investigator |
| Christina A Roberto, PhD | University of Pennsylvania | Principal Investigator |
| Harsha Thirumurthy, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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1,132 individuals were contacted via the electronic health portal. 242 completed the interest form, and of those 142 were excluded due to ineligibility, not interested, unable to contact or unable to schedule. 100 were enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No intervention |
| FG001 | Cash Transfer | Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. Cash Transfer: Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No intervention |
| BG001 | Cash Transfer | Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. Cash Transfer: Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Food Security Category | Change from baseline in food security in the last 30 days as measured by the US Department of Agriculture food security scale. Outcome is 3 ordered categories: high or marginal food security, low food security, very low food security. | 100 enrolled participants at baseline and 93 participants at 3-month follow-up. | Posted | Count of Participants | Participants | Assessed at 1-hour appointment at baseline and 3 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cash Transfer Baseline | Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. Cash Transfer: Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Fabian | University of Pennsylvania | 760-791-2633 | eva.fabian@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2023 | Jun 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2023 | Sep 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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At the end of the baseline assessment, participants will be randomized using a permuted block technique with block size of 4 to either usual care (Arm 1) or to the unconditional cash transfer intervention (Arm 2).
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| Assessed at 1-hour appointment at baseline and 3 months |
| Change in Health Care Expenditures on Medications | Change from baseline in number of dollars spent out-of-pocket on medications in the past 30 days. | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Adherence to Medication Refills Scale | Change from baseline in current adherence to refilling medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 4-16, higher scores indicate lower adherence). | Assessed at 1-hour appointment at baseline and 3 months |
| Once all study appointments are completed, ED visit data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. |
| Change in Number of Health Care Visits (Non-emergency Department) | We had initially hoped to descriptively summarize these outcomes as part of this pilot study, but the staff member leading our analyses departed during the course of this study and we no longer had someone with the skills and bandwidth to pull, merge, and analyze these data from the electronic health record. For that reason, the data were never collected in this sample and so we have not reported these outcomes | Once all study appointments are completed, number of health care visits(non-ED) data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. |
| Change in Cigarette Dependence Scale | Change from baseline in current cigarette dependence as measured by the Cigarette Dependence Scale (short version; 5-25, higher scores indicate more dependence). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Alcohol Use Scale | Change from baseline in current alcohol use as measured by the Alcohol Use Disorders Identification Test (0-12, higher scores indicate more use). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in All Health Care Expenditures | Change from baseline in sum of dollars spent out-of-pocket on medications, office visits, and emergency room visits in the past 30 days. | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Time Preference (Patience) | Change from baseline on current patience which is a single item in the Preference Survey Module (0 "completely unwilling" to 10 "completely willing" to give up present benefits for future benefits, higher scores indicate future preference). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Time Preference (Behavioral Task) | Change from baseline on current snack choice (binary: chose a more or a less healthy snack, choosing a healthy snack indicates future preference). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Psychological Distress Scale | Change from baseline in psychological distress in the past 30 days as measured by the Kessler Psychological Distress Scale (K6+, 6-30, higher scores indicate more distress). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Number of Healthy Days | Change from baseline in self-reported number of healthy days in the past 30 as measured by the CDC Health-Related Quality of Life Scale (0-30 days). | Assessed at 1-hour appointment at baseline and 3 months |
| Change in Adherence to Taking Medications Scale | Change from baseline in current adherence to taking medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 8-32, higher scores indicate lower adherence). | Assessed at 1-hour appointment at baseline and 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| BMI | Count of Participants | Participants |
|
| Household Income | Count of Participants | Participants |
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| Income at the Federal Poverty Level | Calculated using the 2022 federal poverty levels, based on self-reported household size. | Count of Participants | Participants |
|
| On government assistance | Count of Participants | Participants |
|
| Work and School | Count of Participants | Participants |
|
| Main income source | Count of Participants | Participants |
|
| For those with ANY income from a job over the past 3 months (n=52), number of hours worked | This question was asked of the 52 people who reported having ANY income from a job over the past 3 months. This is in contrast to the 50 people for whom a job was the MAIN source of income over the past 3 months, and the 50 people who reported CURRENTLY having a job. | For those who reported source of income as "a job" (n=52) | Mean | Standard Deviation | Hours |
|
| Type of job | This question was asked of the 52 people who reported having ANY income from a job over the past 3 months. This is in contrast to the 50 people for whom a job was the MAIN source of income over the past 3 months, and the 50 people who reported CURRENTLY having a job. | For those who selected "a job" for source of income (n=52) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Number of people in household | Mean | Standard Deviation | Number of people in household |
|
| Kids in household | Count of Participants | Participants |
|
| Living situation | Count of Participants | Participants |
|
Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. Cash Transfer: Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. |
| OG002 | Control Baseline | No intervention |
| OG003 | Control Follow-up | No intervention |
|
|
|
| Primary | Change in Utility Security Category | Change from baseline in utility security in the last 3 months as measured by the Home Energy Insecurity scale. Outcome is 5 ordered categories: thriving, capable, stable, vulnerable, in-crisis. | Posted | Count of Participants | Participants | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Primary | Change in Financial Well-being Scale | Change from baseline in current financial well-being as measured by the Consumer Financial Protection Bureau Financial Well-Being 0-100 scale (higher scores are correlated to more well-being). | Posted | Mean | Standard Deviation | scores on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Primary | Change in Perceived Stress Scale | Change from baseline in perceived stress in the last 30 days as measured by the Perceived Stress Scale (short form; 0-16, higher scores are correlated to more stress). | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Primary | Change in State Anxiety Scale | Change from baseline in current anxiety as measured by the State Trait Anxiety Inventory subscale. The range is from 20-80 with lower scores meaning less anxiety. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Primary | Change in Mental Bandwidth | Change from baseline in number of lapses in the Psychomotor Vigilance Task (more lapses indicate less mental bandwidth). | Posted | Mean | Standard Deviation | Change in Lapses | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Primary | Change in Health Care Expenditures on Medications | Change from baseline in number of dollars spent out-of-pocket on medications in the past 30 days. | Posted | Mean | Standard Deviation | Dollars | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Primary | Change in Adherence to Medication Refills Scale | Change from baseline in current adherence to refilling medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 4-16, higher scores indicate lower adherence). | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Secondary | Change in Number of Emergency Department Visits | We had initially hoped to descriptively summarize these outcomes as part of this pilot study, but the staff member leading our analyses departed during the course of this study and we no longer had someone with the skills and bandwidth to pull, merge, and analyze these data from the electronic health record. For that reason, the data were never collected in this sample and so we have not reported these outcomes | Not Posted | Once all study appointments are completed, ED visit data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. | Participants |
| Secondary | Change in Number of Health Care Visits (Non-emergency Department) | We had initially hoped to descriptively summarize these outcomes as part of this pilot study, but the staff member leading our analyses departed during the course of this study and we no longer had someone with the skills and bandwidth to pull, merge, and analyze these data from the electronic health record. For that reason, the data were never collected in this sample and so we have not reported these outcomes | Not Posted | Once all study appointments are completed, number of health care visits(non-ED) data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. | Participants |
| Secondary | Change in Cigarette Dependence Scale | Change from baseline in current cigarette dependence as measured by the Cigarette Dependence Scale (short version; 5-25, higher scores indicate more dependence). | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Secondary | Change in Alcohol Use Scale | Change from baseline in current alcohol use as measured by the Alcohol Use Disorders Identification Test (0-12, higher scores indicate more use). | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Secondary | Change in All Health Care Expenditures | Change from baseline in sum of dollars spent out-of-pocket on medications, office visits, and emergency room visits in the past 30 days. | Posted | Mean | Standard Deviation | dollars | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Secondary | Change in Time Preference (Patience) | Change from baseline on current patience which is a single item in the Preference Survey Module (0 "completely unwilling" to 10 "completely willing" to give up present benefits for future benefits, higher scores indicate future preference). | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Secondary | Change in Time Preference (Behavioral Task) | Change from baseline on current snack choice (binary: chose a more or a less healthy snack, choosing a healthy snack indicates future preference). | Posted | Count of Participants | Participants | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Secondary | Change in Psychological Distress Scale | Change from baseline in psychological distress in the past 30 days as measured by the Kessler Psychological Distress Scale (K6+, 6-30, higher scores indicate more distress). | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
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|
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| Secondary | Change in Number of Healthy Days | Change from baseline in self-reported number of healthy days in the past 30 as measured by the CDC Health-Related Quality of Life Scale (0-30 days). | Posted | Mean | Standard Deviation | days | Assessed at 1-hour appointment at baseline and 3 months |
|
|
|
|
| Secondary | Change in Adherence to Taking Medications Scale | Change from baseline in current adherence to taking medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 8-32, higher scores indicate lower adherence). | Posted | Mean | Standard Deviation | score on a scale | Assessed at 1-hour appointment at baseline and 3 months |
|
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|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Cash Transfer Follow-up | Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. Cash Transfer: Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. | 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | Control Baseline | No intervention | 0 | 50 | 0 | 50 | 0 | 50 |
| EG003 | Control Follow-up | No intervention | 0 | 44 | 0 | 44 | 0 | 44 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Prefer not to say |
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| Healthy |
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| $15,000 to $24,999 |
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| $25,000 to $34,999 |
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| $35,000 to $49,999 |
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| $50,000 to $74,999 |
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| $75,000 to $99,999 |
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| 75-100% of federal poverty level |
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| 100-133% of federal poverty level |
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| 133%+ of federal poverty level |
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| School and Work |
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| Family or friends |
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| SNAP (Food Stamps) |
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| Unemployment |
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| TANF (Cash Assistance/Welfare) |
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| Veteran Benefits |
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| Hustling (e.g., petty theft) |
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| Government (Local, State, Federal) |
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| Non-Profit Org |
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| Owner non-incorporated business |
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| Some College |
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| Associates/Bachelors+ |
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| Widow/Divorced/Separated |
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| Elsewhere |
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| Vulnerable |
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| Stable |
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| Capable |
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| Thriving |
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| Selected Snack |
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| No Selection |
|