NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 455
- Locations
- 1
- Primary Endpoint
- Mean Psychological Distress Scores at Baseline
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
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
- •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)
Outcomes
Primary Outcomes
Mean Psychological Distress Scores at Baseline
Time Frame: Baseline (Month 0)
The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24. The Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21. To obtain an aggregate score for Psychological Distress, the PHQ \& GAD will be combined. Scores will range from 0-45.
Weight at Month 3
Time Frame: Month 3
Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team.
Mean Psychological Distress Scores at Month 3
Time Frame: 3 Months
The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24. The Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21. To obtain an aggregate score for Psychological Distress, the PHQ \& GAD will be combined. Scores will range from 0-45.
Mean Psychological Distress Scores at Month 6
Time Frame: Month 6
The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24. The Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21. To obtain an aggregate score for Psychological Distress, the PHQ \& GAD will be combined. Scores will range from 0-45.
Mean Psychological Distress Scores at Month 12
Time Frame: Month 12
The Patient Health Questionnaire (PHQ-8) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It is an 8 item scale with each item rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of depression while lower scores indicate lower levels of depression. Scores range from 0-24. The Generalized Anxiety Disorder (GAD-7) is a 7 item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Items are rated on a 4 point scale from "Not at all" (score 0) to "Nearly every day" (score 3). Higher scores indicate higher levels of anxiety while lower scores indicate lower levels of anxiety. Scores range from 0-21. To obtain an aggregate score for Psychological Distress, the PHQ \& GAD will be combined. Scores will range from 0-45.
Weight at Baseline
Time Frame: Baseline (Month 0)
Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team.
Weight at Month 6
Time Frame: Month 6
Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team.
Blood Pressure at Month 6
Time Frame: Month 6
Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury).
Blood Pressure at Month 12
Time Frame: Month 12
Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury).
Weight at Month 12
Time Frame: Month12
Weight will be measured using the Tanita WB-800 Plus professional grade scale. Lightweight and portable, it has a weight capacity of 660 lbs, and has been used in studies of weight gain prevention by others on the research team.
Blood Pressure at Baseline
Time Frame: Baseline (Month 0)
Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury).
Blood Pressure at Month 3
Time Frame: Month 3
Blood Pressure will be assessed using the American Heart Association Guidelines for BP measurement and the Omron HEM-705CPN, which meets strict calibration standards and is validated at +/- 3-5 mmHg (millimeters of mercury).
Secondary Outcomes
- Physical Activity Intensity as Determined by ActiGraph Accelerometer(Up to 12 months)
- Sedentary Bouts as Determined by ActiGraph Accelerometer(Up to 12 months)
- Scores on Smoking Quantity Scale(Up to 12 months)
- Responses to Motivation to Stop Smoking(Up to 12 months)
- Scores on Organizational Citizenship Behaviors Checklist(Up to 12 months)
- Number of Times of Healthcare Utilization(Up to 12 months)
- Total Amount of Supplementary Out-of-pocket costs(Up to 12 months)
- Scores on Situational Stress Scale(Up to 12 months)
- Scores on Coping Strategies Scale(Up to 12 months)
- Scores on Health Self-Regulation Scale(Up to 12 months)
- Number of Steps Taken as Determined by ActiGraph Accelerometer(Up to 12 months)
- MET Rate as Determined by ActiGraph Accelerometer(Up to 12 months)
- Dietary Intake Log(Up to 12 months)
- Scores on Alcohol Use Scale(Up to 12 months)
- Mean Change in Perceived Supervisor Support Scores(Up to 12 Months)
- Scores on Employment Functioning Scale(Up to 12 months)
- Mean Change in Perceived Discrimination Scores(Up to 12 Months)
- Proportion of Days Employed(Up to 12 months)
- Scores on General Health(Up to 12 months)
- Chronic Conditions(At Baseline (Month 0))
- Weeks of Continuous Employment(Up to 12 months)
- Health Care Provider Status(Up to 12 months)
- Health Management Apps/Programs/Wearables Use(Up to 12 months)
- Medication Covariates(Up to 12 months)