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

NCT04815278 | Completed

• 2 other identifiers: 21-08591R01MD012832-01A1
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• Mean Psychological Distress Scores at Baseline

  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.

  Baseline (Month 0)

• Mean Psychological Distress Scores at Month 3

  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.

  3 Months

• Mean Psychological Distress Scores at 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.

  Month 6

• Mean Psychological Distress Scores at 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.

  Month 12

• Weight at Baseline

  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.

  Baseline (Month 0)

• Weight at 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.

  Month 3

• Weight at 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.

  Month 6

• Weight at Month 12

  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.

  Month12

• Blood Pressure at Baseline

  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).

  Baseline (Month 0)

• Blood Pressure at 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).

  Month 3

• Blood Pressure at 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).

  Month 6

• Blood Pressure at 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).

  Month 12

Secondary Outcomes (24)

• 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

• Physical Activity Intensity as Determined by ActiGraph Accelerometer

  Up to 12 months

Other Outcomes (3)

• Responses to CDC Scorecard

  Up to 60 months

• Scores on Chronic Financial Strain Scale

  Up to 12 months

• Scores on Effort-Reward Imbalance Scale

  Up to 12 months

Study Arms (4)

Control Group

EXPERIMENTAL

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.

Behavioral: Delayed, attenuated Chronic Disease Prevention Program (CDPP)

Employer Intervention Only

EXPERIMENTAL

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.

Behavioral: Workplace Equity, Job and Health Supports Employer Intervention

CDPP Only

EXPERIMENTAL

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.

Behavioral: Immediate Chronic Disease Prevention Program (CDPP)

CDPP and Employer Intervention

EXPERIMENTAL

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..

Behavioral: Immediate Chronic Disease Prevention Program (CDPP); Behavioral: Workplace Equity, Job and Health Supports Employer Intervention

Interventions

Immediate Chronic Disease Prevention Program (CDPP) BEHAVIORAL

The CDPP is an adaptation of the Diabetes Prevention Program (DPP). It will take place over a 24 week period and involve online instruction and individualized lifestyle coaching sessions. The online classroom curriculum includes 8 modules: Goal setting, self-monitoring and problem solving (M1), Managing stress and negative thoughts (M2), Healthy eating (M3), Taking more steps (M4), Keeping alcohol in check (M5), Lifestyle change (M6), Taking charge of what (and who) is around you (M7), and Staying motivated (M8). The lifestyle coaches will meet in person and over the phone intermittently over the 24 week period (Weeks 2, 4, 6, 10, 12, 16, 24).

CDPP Only; CDPP and Employer Intervention

Workplace Equity, Job and Health Supports Employer Intervention BEHAVIORAL

The employer intervention combines implicit bias awareness training for supervisors of hired DSS-E clients, and regular, structured, interactions between supervisors and DSS-E hires.

CDPP and Employer Intervention; Employer Intervention Only

Delayed, attenuated Chronic Disease Prevention Program (CDPP) BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease; Weight Loss

Interventions

Occupations

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Shawn Kneipp, Ph. D

  UNC School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: September 17, 2021
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• Access Criteria: The limited-access dataset will be made available at the end of the study. Data will be released in a .csv file. Researchers wishing to use the dataset will be required to obtain approval from UNC using an agreement form that clearly specifies the intended analyses as well as assurances that HIPAA regulations will be followed. If approval is granted, the dataset will be supplied on a CD, or shared using a secure, password-protected medium. It will also include documentation describing the variables in the dataset and copies of the data collection forms used to collect the data.

Locations

US (1)