Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05838027
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2023-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pilot Guaranteed Income Study, Philadelphia, April 2023
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Philly Family Trust Study: A Pilot Randomized Controlled Trial of an Unconditional Cash Transfer to Improve Health Behaviors Among Adults With Chronic Diseases
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGI
Brief Summary:
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:
* How feasible and acceptable is the intervention?
* How are key health behaviors and outcomes affected by the intervention?
* What are reasonable effect sizes to expect in a larger trial?
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.
* How feasible and acceptable is the intervention?
* How are key health behaviors and outcomes affected by the intervention?
* What are reasonable effect sizes to expect in a larger trial?
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P30AG034546-14 | NIH | None | https://reporter.nih.gov/quic… | View |