A Multilevel Intervention to Reduce Chronic Disease Risk in Socioeconomically Disadvantaged Unemployed Populations: The North Carolina Works 4 Health (NCW4H) Clinical Trial Protocol

BackgroundThe overall goal of the North Carolina Works for Health (NCW4H) study is to adapt and test the effectiveness of a multilevel intervention to reduce chronic disease risk in socioeconomically disadvantaged, unemployed (SEDU) populations who rely on publicly-funded job placement programs to secure employment. Studies have shown an unemployment episode increases in psychological distress, health-compromising coping behavior, blood pressure, and weight gain - all of which increase chronic disease risk. MethodsA randomized, 2 x 2 factorial design will test an individual level (IL) and employer level (EL) intervention, and their joint effects, in SEDU adults receiving job placement services through publicly-funded programs. Interventions consist of a chronic disease prevention program adapted from the Diabetes Prevention Program at the IL, and an implicit bias-based supervisor support program for newly-hired SEDU adults at the EL. We will enroll 600 SEDU adults 18 to 64 years of age who have either received public assistance benefits in the prior two years or have <4-year college degree, used publicly-funded job placement services during the most recent unemployment episode, and are not receiving disability income, not pregnant, and fluent in English; and 80-200 supervisors of our SEDU enrolled participants when hired by an employer. Primary outcomes include psychological distress, blood pressure, and weight gain, and will be collected at baseline and 3, 6, and 12 months post-enrollment. Secondary outcomes related to coping, health behavior, workplace support, and employment will also be collected. Main effects of the IL and EL interventions, and IL x EL interactions, will be analyzed using generalized multivariate models accounting for clustering effects. DiscussionThis multilevel intervention is novel in that it is designed to mitigate chronic disease risk during an unemployment episode, and includes an intervention at a level at the employer level, where social determinants of health operate. Despite the design challenges that multilevel intervention trials such as the NCW4H study present, they are needed to meaningfully address health inequities in the U.S. Findings from this study are expected to inform how approaches that incorporate public health and employment sectors could reduce chronic disease among socioeconomically disadvantaged populations. Ethics and disseminationThe trial is ongoing and has been approved by the University of North Carolina at Chapel Hill Institutional Review Board. Trial results will be published in a scientific journal and presented at scientific conferences. Trial registration numberNCT04815278, ClinicalTrials.gov