Chronic Disease Prevention Program for Chronic Disease

(NCW4H Trial)

Overseen By Shawn Kneipp, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Disability benefits, Pregnancy, Severe hypertension, Cancer, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the Chronic Disease Prevention Program safe for humans?

The available research does not provide specific safety data for the Chronic Disease Prevention Program or its variations, but workplace health programs generally focus on promoting healthy behaviors and improving health outcomes, which suggests they are designed with safety in mind. ^{1 2 3 4 5}

How is the Chronic Disease Prevention Program (CDPP) treatment unique compared to other treatments for chronic disease?

The Chronic Disease Prevention Program (CDPP) is unique because it integrates health promotion and protection in the workplace, focusing on improving individual health behaviors and supporting the work-family interface, which is not typically addressed in standard treatments for chronic diseases. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Delayed, attenuated Chronic Disease Prevention Program (CDPP) and related interventions?

Research shows that workplace health programs, like the ones in the study, can help people with chronic conditions like diabetes and high blood pressure improve their health habits and better understand their conditions. These programs also support employees in managing their health and returning to work, which suggests they can be effective in preventing and managing chronic diseases. ^{3 4 6 8 9}

Who Is on the Research Team?

Shawn Kneipp, Ph. D

Principal Investigator

UNC School of Nursing

Are You a Good Fit for This Trial?

This trial is for unemployed individuals aged 18-64, receiving DSS-E services, and fluent in English. It's not for those on or applying for disability benefits, with severe high blood pressure, balance issues due to a health condition or injury, recent falls, active cancer treatment involving chemotherapy or radiation to the chest/abdomen area, inflammatory bowel disease like Crohn's or ulcerative colitis, an implanted cardiac defibrillator, or if pregnant.

Inclusion Criteria

I am receiving disability support services.

fluent and able to read English

You do not have a job.

Exclusion Criteria

You are currently pregnant.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Adaptation

With community partners and key stakeholders, make minor adaptations to two evidence-based interventions for use in a multilevel intervention.

Not specified

Phase II: Intervention

Test the main effects of the individual-level and employer-level NC Works4Health interventions on primary and secondary outcomes over time.

12 months

Data collection at Baseline, Months 3, 6, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delayed, attenuated Chronic Disease Prevention Program (CDPP)
• Immediate Chronic Disease Prevention Program (CDPP)
• Workplace Equity, Job and Health Supports Employer Intervention

Trial Overview The NC Works4Health study tests a multilevel intervention aimed at reducing chronic disease risks among socioeconomically disadvantaged people by integrating prevention efforts into employment programs and improving employer support. Participants will either receive an immediate Chronic Disease Prevention Program (CDPP), job supports and workplace equity interventions from employers or a delayed version of CDPP.

How Is the Trial Designed?

Group I: Employer Intervention Only Experimental Treatment 1 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.

Group II: Control Group Experimental Treatment 1 Intervention

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.

Group III: CDPP and Employer Intervention Experimental Treatment 2 Interventions

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..

Group IV: CDPP Only Experimental Treatment 1 Intervention

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.

Delayed, attenuated Chronic Disease Prevention Program (CDPP) is already approved in United States for the following indications:

Approved in United States as Chronic Disease Prevention Program for:

• Chronic disease prevention
• Psychological distress
• Weight gain
• Blood pressure management

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The study identified four key mechanisms that contribute to the success of chronic disease prevention and management (CDPM) programs: patient-centred interdisciplinary care, self-management support, professional support, and effective care coordination.

Contextual factors such as patient multimorbidity, family caregiver involvement, healthcare provider training, and organizational collaboration significantly influence the effectiveness of these mechanisms, highlighting the importance of a supportive environment for CDPM programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic disease prevention and management programs in primary care: Realist synthesis of 6 programs in Quebec. Ramond-Roquin, A., Chouinard, MC., Diallo, BB., et al.[2020]

A work site disease management program led by an advanced practice nurse positively influenced health behaviors in participants with dyslipidemia and diabetes, indicating its efficacy in managing these conditions.

Participants reported improved understanding of their health conditions, such as dyslipidemia and hypertension, and better control of asthma, highlighting the program's effectiveness and high satisfaction among employees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Work site disease management outcomes: expanding the role of the APN. Carioti, CA., Lavigne, JE., Stone, P., et al.[2019]

Chronic disease is the leading cause of death in the U.S., highlighting the urgent need for effective health promotion and protection strategies in the workplace.

A workshop by the National Institutes of Health and the Centers for Disease Control and Prevention established a research agenda to integrate health promotion and occupational safety measures to reduce chronic disease risk among workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing chronic disease in the workplace: a workshop report and recommendations. Sorensen, G., Landsbergis, P., Hammer, L., et al.[2021]

The California Department of Health Services (CDHS) has developed guidelines to help employers assess the quality of worksite health promotion programs, addressing concerns about the lack of established quality standards and outcomes in these programs.

The guidelines emphasize the importance of integrating health promotion programs with medical oversight, environmental changes, and organizational policies to effectively support employees in adopting and maintaining healthier behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assessment in worksite health promotion. Kizer, KW., Folkers, LF., Felten, PG., et al.[2004]

Workplace-oriented and multidisciplinary programs are highly effective in supporting workers with chronic diseases to return to work and reduce absenteeism, based on a systematic review of 15 randomized controlled trials involving adult employees.

Cognitive behavioral therapies and coaching also show positive outcomes, with coaching particularly enhancing self-management of chronic diseases and improving workers' perceptions of their capacity to work and manage fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Diseases and Employment: Which Interventions Support the Maintenance of Work and Return to Work among Workers with Chronic Illnesses? A Systematic Review. Nazarov, S., Manuwald, U., Leonardi, M., et al.[2020]

The CPPW program, which invested $485 million in community health initiatives, is projected to prevent 14,000 premature deaths and save $2.4 billion in direct medical costs by 2020.

Sustained implementation of these community interventions could lead to significant long-term cost savings and health benefits, potentially yielding returns many times greater than the initial investment over the next 10 to 20 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Interventions to Decrease Obesity and Tobacco Exposure and Reduce Health Care Costs: Outcome Estimates From Communities Putting Prevention to Work for 2010-2020. Soler, R., Orenstein, D., Honeycutt, A., et al.[2022]

Workplaces have a significant opportunity to improve the health of employees through various health promotion and chronic disease prevention activities, such as health screenings, tobacco cessation, and promoting healthy food choices.

The review introduces the SWOLE model, which outlines key factors for implementing effective health programs at work, highlighting the need to tailor these initiatives to the specific needs of blue-collar versus white-collar workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Promotion and Chronic Disease Prevention at the Workplace. Andersen, LL.[2023]

A collaborative project in Québec has successfully combined epidemiology, community organization, and medical care to address and promote recognition of work-related diseases, especially for non-unionized workers.

The project highlights both achievements and challenges in establishing a causal link between working conditions and health outcomes, showcasing the importance of interdisciplinary approaches in public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recognition of work-related diseases: an original collaborative project in Québec. King, N.[2007]

A comprehensive workplace health promotion program implemented at a large company with 110,000 employees led to a significant 47.5% reduction in absenteeism at one pilot location over six years, compared to a 12.5% decline in the overall workforce.

The program utilized a structured needs assessment and involved various interventions, including health risk assessments and lifestyle change activities, highlighting the importance of tailored approaches in improving employee health and reducing absenteeism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning and implementing health promotion in the workplace: a case study of the Du Pont Company experience. Bertera, RL.[2019]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Chronic disease prevention and management programs in primary care: Realist synthesis of 6 programs in Quebec. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Work site disease management outcomes: expanding the role of the APN. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Preventing chronic disease in the workplace: a workshop report and recommendations. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Quality assessment in worksite health promotion. [2004]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Diseases and Employment: Which Interventions Support the Maintenance of Work and Return to Work among Workers with Chronic Illnesses? A Systematic Review. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Community-Based Interventions to Decrease Obesity and Tobacco Exposure and Reduce Health Care Costs: Outcome Estimates From Communities Putting Prevention to Work for 2010-2020. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Health Promotion and Chronic Disease Prevention at the Workplace. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Recognition of work-related diseases: an original collaborative project in Québec. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Planning and implementing health promotion in the workplace: a case study of the Du Pont Company experience. [2019]