Viewing Study NCT04815278



Ignite Creation Date: 2024-05-06 @ 3:56 PM
Last Modification Date: 2024-10-26 @ 2:00 PM
Study NCT ID: NCT04815278
Status: RECRUITING
Last Update Posted: 2024-06-03
First Post: 2021-03-22

Brief Title: NC Works4Health Reducing Chronic Disease Risks in Socioeconomically Disadvantaged Unemployed Populations
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: NC Works4Health Reducing Chronic Disease Risks in Socioeconomically Disadvantaged Unemployed Populations
Status: RECRUITING
Status Verified Date: 2024-05
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: NCW4H
Brief Summary: The proposed study NC Works4Health NCW4H builds on the strengths of long-standing academic-community research partnerships between this UNC at Chapel Hill UNC team of investigators and key stakeholders across health social service employment and economic development sectors The overall goal of this study is to test the effectiveness of a multilevel intervention that can be readily adopted by communities to reduce chronic disease risks in socioeconomically disadvantaged populations by a embedding prevention efforts in DSS-E programs at the individual level and b enhancing supervisor supports for DSS-E hires at the employer level Interventions at each level and their joint effects are designed to mitigate the psychological behavioral and clinically relevant risks for chronic disease onset morbidity and comorbidity that accrue with unemployment and the employment-entry transition
Detailed Description: Studies have shown that a single episode of unemployment can trigger a cascade of stress-related coping and behavioral processes that have deleterious effects on health Notably this cascade not only frequently results in psychological distress but also accelerated weight gain persisting up to 10 years regardless of re-employment and elevated blood pressure As such individuals who experience unemployment are at a much higher risk for chronic disease development comorbidity and early mortality Given inequities in the labor market socioeconomically disadvantaged groups ie those with less education less income or wealth andor who are racialethnic minorities are disproportionately and more adversely affected by both unemployment and chronic disease and feel this burden acutely in their everyday lives Socioeconomically disadvantaged adults often receive public assistance benefits during unemployment episodes as well as job training and placement services through Department of Social Services Employment DSS-E programs however these programs do not include prevention-focused content to reduce the chronic disease risks that accrue during unemployment episodes In addition DSS-E efforts to help individuals succeed in securing and performing in a new job are often thwarted by implicit welfare-related bias and insufficient supports in workplaces into which DSS-E clients are hired Although the current absence of chronic disease prevention in DSS-E programs and lack of supports for DSS-E hires in workplaces compound chronic disease risks it is also an area in which communities can address social determinants that are known to produce health inequities

The proposed study NC Works4Health NCW4H builds on the strengths of long-standing academic-community research partnerships between this UNC at Chapel Hill UNC team of investigators and key stakeholders across health social service employment and economic development sectors The overall goal of this study is to test the effectiveness of a multilevel intervention that can be readily adopted by communities to reduce chronic disease risks in socioeconomically disadvantaged populations by a embedding prevention efforts in DSS-E programs at the individual level and b enhancing supervisor supports for DSS-E hires at the employer level Interventions at each level and their joint effects are designed to mitigate the psychological behavioral and clinically relevant risks for chronic disease onset morbidity and comorbidity that accrue with unemployment and the employment-entry transition By collaborating across sectors to reduce health inequities the specific aims will be met in two phases

Phase I

With community partners and key stakeholders make minor adaptations to two evidence-based interventions for use in a multilevel intervention that incorporates a a chronic disease prevention program CDPP individual levelinto current DSS-E programs for unemployed adults and b supervisor support in the workplace employer levelinto an existing network of employers with jobs that match the skill set of the DSS-E program population

Phase II

Aim 1 To test the main effects of a the individual-level NC Works4Health intervention Usual DSS-E CDPP compared to Usual DSS-E Support and b the employer-level NC Works4Health intervention compared to usual workplace supports on primary and secondary outcomes over time at 3 6 and 12 months from baseline using a randomized 2x2 factorial design

Aim 2 To test the joint effect of the individual-level employer-level NC Works4Health interventions on primary and secondary outcomes over time at 3 6 and 12 months from baseline

In the primary outcomes the investigators expect to see a decrease in psychological distress weight gain and blood pressure in groups receiving the intervention at each level with the greatest decreases in the outcomes observed in the group receiving both the individual- and employer-level interventions

Secondary outcomes include situational stress coping style health behaviors perceived workplace support health-related employment functioning and employment duration

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
1R01MD012832-01A1 NIH None httpsreporternihgovquickSearch1R01MD012832-01A1