PATHWEIGH, Pragmatic Weight Management in Adult Patients in Primary Care in Colorado, USA: Study Protocol for a Stepped Wedge Cluster Randomized Trial

Background: PATHWEIGH, a pragmatic approach to weight management, aims to adequately address obesity in a healthcare setting. PATHWEIGH uses tools built into the electronic medical record to overcome barriers and guide care. This current study aims to compare the effectiveness of PATHWEIGH to standard of care on patient wait loss in primary care, and explore how this approach can be successfully implemented.

Methods: This study uses a stepped wedge cluster randomized trial within an effectiveness-implementation hybrid design to compare PATHWEIGH with standard care for adult weight loss and maintenance across 57 clinics in Colorado. The effectiveness will be assessed using statistical models to analyze eight outcomes at 6, 12, and 18 months, along with analyses of patient-, provider-, and clinic-level factors. A mixed-methods approach, guided by the PRISM framework, will evaluate implementation factors and strategies. The study also includes a cost analysis comparing PATHWEIGH’s resource requirements to reimbursement collected.

Discussion: The clinical trial will focus on the effectiveness and implementation of PATHWEIGH in primary care settings.