Methods of an Exercise is Medicine-Mediated Behavioral Counseling Intervention in Patients At-Risk for Cardiovascular Disease: The Vitalis Cardio Study

Introduction: Cardiovascular diseases (CVDs) are the leading causes of death in the U.S. Having a healthy dietary pattern and engaging in regular physical activity (PA) reduces the risk of developing CVDs. The U.S. Preventative Services Task Force and the American College of Sports Medicine's Exercise is Medicine (EIM) initiatives recommend patients at risk for CVDs receive behavioral counseling interventions (BCIs). However, few patients are screened for lifestyle behaviors and connected with evidence-based BCIs. Purpose: To describe (1) our approaches for identifying insufficiently active patients and connecting them to evidence-based BCIs and (2) the methods of our 12-week, theory-based BCI for insufficiently active patients. Methods: A novel clinical workflow was implemented in six Family Medicine clinics to screen and refer insufficiently active patients to a 12-week BCI. The BCI is theoretically grounded in the Multi-Process Action Control (M-PAC) framework and includes health education, health coaching, and self-monitoring. The implementation and preliminary efficacy of the workflow and BCI will be evaluated with the RE-AIM framework. Implementation outcomes include clinical workflow metrics and BCI acceptability and fidelity. Preliminary efficacy includes changes in psychosocial mechanisms of action, device-based and self-reported health behaviors, and health outcomes. Efficacy outcomes are assessed at baseline, post-intervention, with a subset of outcomes assessed after 12 weeks of post-intervention follow-up. Conclusion: This clinical workflow and BCI will inform the future implementation of primary care-based BCIs to reduce the risk of developing CVD in insufficiently active patients.