Clinical trial NCT04815278: NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations
Official title: NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Chronic Disease
Psychological Distress
Keywords: Unemployment
Weight Maintenance
Unintentional Bias
Employment Services
Self-Monitoring
Perceived Workplace Support
Step Count
Coping Strategies
Blood Pressure
Food Tracking
Problem-Solving
Weight Loss
Underemployment
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-03-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Random 2x2 factorial design. The temporal nature of the phenomenon under study requires individuals (DSS-E participants) are first randomized to the individual-level treatment group, follow them as they are naturally hired into employment settings, and then enroll / randomize / allocate employers to the employer-level treatment group
Primary purpose: PREVENTION

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 (i.e., those with less education, less income or wealth, and/or who are racial/ethnic 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 level)into current DSS-E programs for unemployed adults, and (b) supervisor support in the workplace (employer level)into 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.

Eligibility criteria: Inclusion Criteria:

* receiving DSS-E services
* between the age of 18 and 64 years old
* unemployed
* fluent and able to read English

Exclusion Criteria:

* receiving or applied for disability benefits
* pregnant
* Any of the following chronic conditions: severe high blood pressure (with a reading of 180/110 or higher in the past 6 months), a health condition or injury that has left you unsteady, or unbalanced when you walk, a history of falling in the past 6 months, cancer that is actively being treated with chemotherapy of radiation to your chest or abdomen (stomach area), inflammatory bowel disease (such as Crohn's disease, or ulcerative colitis), an implanted cardiac defibrillator (a small device placed under the skin on your chest to help your heart function)

Primary outcomes:
measure: Mean Psychological Distress Scores at Baseline
timeFrame: Baseline (Month 0)
measure: Mean Psychological Distress Scores at Month 3
timeFrame: 3 Months
measure: Mean Psychological Distress Scores at Month 6
timeFrame: Month 6
measure: Mean Psychological Distress Scores at Month 12
timeFrame: Month 12
measure: Weight at Baseline
timeFrame: Baseline (Month 0)
measure: Weight at Month 3
timeFrame: Month 3
measure: Weight at Month 6
timeFrame: Month 6
measure: Weight at Month 12
timeFrame: Month12
measure: Blood Pressure at Baseline
timeFrame: Baseline (Month 0)
measure: Blood Pressure at Month 3
timeFrame: Month 3
measure: Blood Pressure at Month 6
timeFrame: Month 6
measure: Blood Pressure at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Scores on Situational Stress Scale
timeFrame: Up to 12 months
measure: Scores on Coping Strategies Scale
timeFrame: Up to 12 months
measure: Scores on Health Self-Regulation Scale
timeFrame: Up to 12 months
measure: Number of Steps Taken as Determined by ActiGraph Accelerometer
timeFrame: Up to 12 months
measure: Physical Activity Intensity as Determined by ActiGraph Accelerometer
timeFrame: Up to 12 months
measure: Sedentary Bouts as Determined by ActiGraph Accelerometer
timeFrame: Up to 12 months
measure: MET Rate as Determined by ActiGraph Accelerometer
timeFrame: Up to 12 months
measure: Dietary Intake Log
timeFrame: Up to 12 months
measure: Scores on Alcohol Use Scale
timeFrame: Up to 12 months
measure: Scores on Smoking Quantity Scale
timeFrame: Up to 12 months
measure: Responses to Motivation to Stop Smoking
timeFrame: Up to 12 months
measure: Scores on Employment Functioning Scale
timeFrame: Up to 12 months
measure: Mean Change in Perceived Discrimination Scores
timeFrame: Up to 12 Months
measure: Mean Change in Perceived Supervisor Support Scores
timeFrame: Up to 12 Months
measure: Proportion of Days Employed
timeFrame: Up to 12 months
measure: Weeks of Continuous Employment
timeFrame: Up to 12 months
measure: Number of Times of Healthcare Utilization
timeFrame: Up to 12 months
measure: Total Amount of Supplementary Out-of-pocket costs
timeFrame: Up to 12 months
measure: Scores on Organizational Citizenship Behaviors Checklist
timeFrame: Up to 12 months
measure: Scores on General Health
timeFrame: Up to 12 months
measure: Health Care Provider Status
timeFrame: Up to 12 months
measure: Chronic Conditions
timeFrame: At Baseline (Month 0)
measure: Health Management Apps/Programs/Wearables Use
timeFrame: Up to 12 months
measure: Medication Covariates
timeFrame: Up to 12 months
Other outcomes:
measure: Responses to CDC Scorecard
timeFrame: Up to 60 months
measure: Scores on Chronic Financial Strain Scale
timeFrame: Up to 12 months
measure: Scores on Effort-Reward Imbalance Scale
timeFrame: Up to 12 months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC School of Nursing
name: Shawn Kneipp, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: