NC Works4Health: Reducing Chronic Disease Risks in Socioeconomically Disadvantaged, Unemployed Populations

Not Applicable

Recruiting

• Conditions: Chronic Disease; Psychological Distress; Diabetes
• Interventions: Behavioral: Workplace Equity, Job and Health Supports Employer Intervention; Behavioral: Delayed, attenuated Chronic Disease Prevention Program (CDPP); Behavioral: Immediate Chronic Disease Prevention Program (CDPP)

• Registration Number: NCT04815278
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-25
• Study Start: 2021-09-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-08
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Employer Intervention Only	Workplace Equity, Job and Health Supports Employer Intervention	Participants will receive usual DSS employment services and an employer level workplace equity, job \& health supports intervention. The employer intervention will include an implicit bias workshop and supervisor support training in addition to regular supervisor check-ins every other week.
Control Group	Delayed, attenuated Chronic Disease Prevention Program (CDPP)	Participants will receive usual DSS employment services that include, but are not limited to, consultation with an employments specialist, resume writing guidance, educational classes and attendance at job fairs. Participants will have access to a delayed, attenuated online-only version of the CDPP at the time they complete the 12 month data collection. This version will provide all modules, self-monitoring options (including through use of a Fitbit contingent on the completion of the 12 month data collection) but will not include face-to-face or phone lifestyle coach sessions.
CDPP and Employer Intervention	Immediate Chronic Disease Prevention Program (CDPP)	Participants will receive the individual level CDPP intervention and employer level workplace equity, job \& health supports intervention. The CDPP is a 24-week online curriculum that consists of 8 learning modules and 7 lifestyle coach sessions and check-ins. Content for the program will include healthy lifestyle habits, managing stress and staying motivated. The employer intervention will include an implicit bias workshop and supervisor support training, in addition to regular supervisor check-ins every other week..
CDPP Only	Immediate Chronic Disease Prevention Program (CDPP)	Participants will receive the individual level CDPP intervention and no employer intervention. The CDPP is a 24-week online curriculum that consists of 8 learning modules and 7 lifestyle coach sessions. Content for the program will include healthy lifestyle habits, managing stress and staying motivated.
CDPP and Employer Intervention	Workplace Equity, Job and Health Supports Employer Intervention	Participants will receive the individual level CDPP intervention and employer level workplace equity, job \& health supports intervention. The CDPP is a 24-week online curriculum that consists of 8 learning modules and 7 lifestyle coach sessions and check-ins. Content for the program will include healthy lifestyle habits, managing stress and staying motivated. The employer intervention will include an implicit bias workshop and supervisor support training, in addition to regular supervisor check-ins every other week..

Primary Outcome Measures

Name	Time	Method
Mean Psychological Distress Scores at Baseline	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	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	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	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	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Physical Activity Intensity as Determined by ActiGraph Accelerometer	Up to 12 months	ActiGraph wGT3X-BT, 3-axis accelerometers will measure physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates mean physical activity intensity values using using units of Moderate to Vigorous Physical Activity (MVPA). Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12.
Sedentary Bouts as Determined by ActiGraph Accelerometer	Up to 12 months	ActiGraph wGT3X-BT, 3-axis accelerometers will measure physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates sedentary "bouts" in units of time (seconds). Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12.
Scores on Smoking Quantity Scale	Up to 12 months	The Patient-Reported Outcomes Measurement Information System (PROMIS) Smoking Module assesses smoking quantity. The PROMIS Smoking module is a 10 item measure rated on a 5-point scale from "Never" (score 1) to "Always" (score 5). Higher scores indicate higher levels of smoking while lower scores indicate lower levels of smoking. Scores range from 10-50. These scores will only be reported for participants that indicate they are current smokers. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Responses to Motivation to Stop Smoking	Up to 12 months	The Motivation to Stop Scale (MTSS) assesses readiness to quit. The MTSS is a 1 item multiple choice measure with 7 options. These scores will only be reported for participants that indicate they are current smokers. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Scores on Organizational Citizenship Behaviors Checklist	Up to 12 months	The Organizational Citizenship Behaviors Checklist (OCB-C) Scale assesses the frequency of employee behaviors that go above and beyond job responsibilities. The OCB-C is a 20-item scale that is scored on a 5-point Likert scale (1= Never, 5= Every day). High scores indicate more organizational citizenship behaviors. Low scores indicate less organizational citizenship behaviors. Scores range from 20-100. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Number of Times of Healthcare Utilization	Up to 12 months	Participants will self-report their health care utilization by point of service in the previous three months (e.g., ER visits, meds). Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Total Amount of Supplementary Out-of-pocket costs	Up to 12 months	Participants will self-report total amount of supplementary out-of-pocket costs (e.g., dietary supplements, gym classes, health-related equipment) in the previous three months. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Scores on Situational Stress Scale	Up to 12 months	Situational stress will be measured by the Perceived Stress Scale (PSS), a 14 item measure of the extent to which the circumstances of one's life are appraised as stressful. Each item is rated on a 5-point scale from "Never" (score 0) to "Very Often" (score 4). Higher scores indicate higher levels of stress while lower scores indicate lower levels of stress. Scores range from 0-56. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Scores on Coping Strategies Scale	Up to 12 months	Coping style will be measured by the Coping Strategies Inventory (CSI), a 32 item measure designed to assess coping thoughts and behaviors in response to a specific stressor. Each item is rated on a 5-point scale from "Not at All" (score 1) to "Very Much" (score 5). Higher scores indicate higher levels of coping while lower scores indicate lower levels of coping. Scores range from 32-160. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Scores on Health Self-Regulation Scale	Up to 12 months	Health Self-Regulation will be gauged by the Index of Self-Regulation (ISR) which measures Stimulus Control, Reconditioning, and Behavioral Monitoring self-regulation domains. The ISR is a 12- item measure rated on a 6-point scale from "Strongly Disagree" (score 1) to "Strongly Agree" (score 6). Higher scores indicate higher levels of self-regulation while lower scores indicate lower levels of self-regulation. Scores range from 12-72. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Number of Steps Taken as Determined by ActiGraph Accelerometer	Up to 12 months	ActiGraph wGT3X-BT, 3-axis accelerometers will measure physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates mean number of steps taken. Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12.
MET Rate as Determined by ActiGraph Accelerometer	Up to 12 months	ActiGraph wGT3X-BT, 3-axis accelerometers will measure Metabolic Equivalent (MET) physical activity over 3 days. These are small, water resistant, lightweight, and worn on the wrist or hip. Data download electronically; algorithm generates a mean MET rate. Measurements will be assessed for a 3 day period at Baseline (Month 0), and Months 3, 6, and 12.
Dietary Intake Log	Up to 12 months	NCI's Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24®) will collect all dietary intake data over 3 days. With portion size images, accuracy of the ASA24® (+/- 3.7g) now supersedes that of the long-standing gold standard. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Scores on Alcohol Use Scale	Up to 12 months	The Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Use scale will assess the consumption quantity and frequency, and problem drinking. It is a 14 item measure rated on a 5-point scale from "Never" (score 1) to "Almost Always" (score 5). Higher scores indicate higher levels of alcohol use while lower scores indicate lower levels of alcohol use. Scores range from 14-70. Outcome data will be collected at Baseline (Month 0) and a Months 3, 6, and 12.
Scores on Employment Functioning Scale	Up to 12 months	The Work Limitations Questionnaire (WLQ) captures health-related absenteeism and presenteeism. The WLQ is a 25 item measure rated on a 5-point scale from "None of the time" (score 1) to "All of the time" (score 5). Higher scores indicate higher levels of employment functioning while lower scores indicate lower levels of employment functioning. Average item scores will be calculated to a 25-125 range. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Mean Change in Perceived Discrimination Scores	Up to 12 Months	The Perceived Supervisor Discrimination scale (adapted) is an aggregate measure of two short measures: the job harassment index and the treated unfairly on job index. The job harassment index consists of 2 items and the treated unfairly on job index consists of 3 items. Each is rated on the same 5 point scale from Never (score 0) to 1+ times a week (score 4). Higher scores indicate higher occurrences of harassment/unfair treatment. Scores range from 0-20. Because the 2 sub-scales are rated on the same 5-point scale, the scores will be added together for an aggregate score. Measurements will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Mean Change in Perceived Supervisor Support Scores	Up to 12 Months	The Perceived Supervisor Support Scale is a 12 item measure that quantitatively captures employee's relationship with their supervisor and the extent to which they believe their supervisor is supportive of them. The scale is adapted from the Perceived Organizational Support scale by replacing the word "Organization" with "Supervisor. Respondents indicate their agreement with each item using a 7-point Likert-type scale (0=strongly disagree, 6=strongly agree). Higher scores indicate higher levels of agreement. Scores range from 0-72. Measurements will be assessed at Baseline (Month 0), and Months 3, 6, and 12.
Proportion of Days Employed	Up to 12 months	Employment duration will be measured by Person-Time Employed (proportion of days employed regardless of breaks in employment) over the entire one year study period. Employment start and stop dates will be collected at each of the data collection time points (Baseline (Month 0), and Months 3, 6, and 12). Employment duration proportion will be calculated after the 12 month data collection.
Scores on General Health	Up to 12 months	The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health assesses general health. The PROMIS Global Health module is a 10 item measure rated on a 5-point scale from "Excellent" (score 1) to "Poor" (score 5). Higher scores indicate poorer health while lower scores indicate better health. Scores range from 10-50. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Chronic Conditions	At Baseline (Month 0)	Participants will answer a single item that asks for all chronic conditions they have ever had that have been diagnosed by a health care professional. There is a list of 28 chronic condition options. Participants may choose multiple conditions. This item will not be scored.
Weeks of Continuous Employment	Up to 12 months	Employment duration will be measured by Continuous Employment (number of consecutive weeks employed, with any reported work in a given week counted as a positive week of employment) over the entire study period. Continuous weeks of employment will be collected at each of the data collection time points (Baseline (Month 0), and Months 3, 6, and 12). Weeks continuous employment will be calculated after the 12 month data collection.
Health Care Provider Status	Up to 12 months	Participants will answer a single item that asks if they currently have a primary health care provider. Answer choices are binary; yes or no. This item will not be scored. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Health Management Apps/Programs/Wearables Use	Up to 12 months	The Health Management Use scale measures how frequently participants have used apps, gadgets, or strategies to manage their health in the last 3 months. It is a 13 item measure rated on a 4-point scale from "Used daily or almost daily" (score 1) to "Have not used" (score 4) scale. Higher scores indicate less health management use while lower scores indicate more health management use. Scores range from 13-52. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.
Medication Covariates	Up to 12 months	A single item about current medications: Diabetes (Thiazolidinediones, Sulfonylureas, insulin), Anti-psychotics (Haloperidol,Clozapine, Risperidone, Olanzapine, Quetiapine, Lithium, Valproic acid, Carbamezapine), Anti-depressants (Amitriptyline, Imipramine, Paroxetine, Escitalopram, Citalopram, Mirtazapine, Sertraline), Anti-epileptics (Valproate, Divalproex, Carbamazepine, Gabapentin, nortriptyline, valproic acid), Steroids (Prednisone, prednisolone, Cortisone, methylprednisolone, Anti-hypertensives, Propranolol, Metoprolol, Amiodipine, Conidine, atenolol), Diabetes (Metformin, Liraglutide), Bronchodilator (Theophylline), Stimulants (Methylphenidate, Dextroamphetamine), Anticonvulsant (Topiramate), Antidepressant (Bupropion, Fluoxetine), Anti-inflammatory (Sulphasalazine), Other weight loss medications (Orlistat, Lorcaserin, Phentermine-topiramate, Naltrexone-bupropion). The item is multiple choice. Outcome data will be collected at Baseline (Month 0), and Months 3, 6, and 12.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States