- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03226548
Effect of EITC on Biological Markers of Aging, Health and Mortality (PaycheckPlus)
April 4, 2022 updated by: Columbia University
An Experimental Investigation Into the Impact of Socioeconomic Context on Biological Markers of Aging, Health and Mortality
Paycheck Plus (PP) is a randomized controlled experiment (RCT) that explores the health and longevity effects associated with increasing the Earned Income Tax Credit (EITC).
EITC is a national program that provides tax credits to low-income, disproportionately minority workers who file taxes.
EITC is politically popular, having received bipartisan support.
The EITC, along with state supplemental programs, have 7 million American families out of poverty.
The investigators' preliminary data analyses show that the EITC has had large population health impacts, reversing declines in self rated health and survival among the poorest Americans.
Study Overview
Detailed Description
Poverty disproportionately impacts minority and rural populations and is very strongly correlated with poor health over the life cycle, and has been hypothesized to lead to a shorter, less healthy aging process.
Poverty is associated with a greater burden of disease than smoking and obesity combined and accounts for the bulk of health disparities by race.
It is widely believed that an antipoverty policy, such as Earned Income Tax Credit (EITC), could improve healthy aging among working-age low-income adults over the life cycle.
It does so by increasing material hardship and psychological stress, two risk factors that are strongly correlated with biological markers of premature aging (e.g., shorter telomeres, higher cholesterol levels, and higher blood pressure).
Study Type
Interventional
Enrollment (Actual)
1350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30303
- Westat
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a US resident
- Filed taxes
- Earned <$30,000 in the previous year
- Aged 21-64
- Have a Social Security number
Exclusion Criteria:
- Eligible for Supplemental Security Income or Social Security Disability Insurance
- Married
- Have dependent children
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Paycheck Plus: Participants will receive four times the standard Earned Income Tax Credit after filing their annual taxes
|
A four-fold increase in the Earned Income Tax Credit
|
No Intervention: Control
Control participants will receive the standard Earned Income Tax Credit after filing their annual taxes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Score on the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 4 Years
|
Depression will be measured using the subject's score on the PHQ-9.
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4 Years
|
EuroQol 5D5L
Time Frame: 4 years
|
Health-related quality of life
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Body Mass Index (BMI)
Time Frame: 2 Years
|
A measure of obesity
|
2 Years
|
Telomere length
Time Frame: 4 years
|
Telomere length is a measure of biological age
|
4 years
|
Mortality
Time Frame: 4 years
|
We will link records to National Death Index for future study
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Muennig, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2016
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
July 18, 2017
First Submitted That Met QC Criteria
July 20, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
April 4, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- AAAQ9663 (ADD-ON)
- R01AG054466 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
To protect participant privacy we cannot share our data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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