Currently submitted to: JMIR Research Protocols
Date Submitted: Jun 3, 2026
Open Peer Review Period: Jun 4, 2026 - Jul 30, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Jefferson Lifestyle Program: Protocol for an Implementation Study
ABSTRACT
Background:
Chronic illnesses such as cardiovascular disease and diabetes represent eight of the ten leading causes of death in the United States and are strongly influenced by modifiable behavioral changes. Lifestyle medicine offers an evidence-based framework for addressing this through interventions focused on nutrition, physical activity, sleep, stress management, social connection, and avoidance of risky substances. However, health systems face persistent barriers to systematic implementation, including competing priorities, clinician time constraints, limited training, and variable reimbursement models. Consequently, scalable, sustainable lifestyle medicine programs embedded within routine clinical care remain uncommon.
Objective:
This study aims to develop, implement, and evaluate a yearlong, virtual intensive lifestyle medicine intervention across a large health system. The objectives are: (1) to implement an evidence-based group medical visit model for adults aged ≥18 years with a body mass index (BMI) ≥18.5, with a target enrollment of 5,200 participants during a two-year active implementation period; and (2) to assess program reach, effectiveness, adoption, implementation fidelity, and maintenance using the REAIM framework.
Methods:
The Jefferson Lifestyle Program will utilize a nonrandomized hybrid type 2 implementation-effectiveness evaluation design. Guided by the Practical, Robust Implementation and Sustainability Model (PRISM) and the outcomes-based Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, the study will use an explanatory-sequential mixed-methods approach, with quantitative analyses of clinical and implementation outcomes supplemented by qualitative data from clinician and participant focus groups. The intervention includes an initial advanced practice clinician (APC) visit; 12 weekly virtual group medical visits co-led by APCs and registered dietitians; monthly social connection sessions; and continuous engagement through an online platform. Primary outcomes include changes in weight, blood pressure, and hemoglobin A1c at 6, 9, 12, and 24 months, as well as emergency department utilization and hospitalizations. Secondary outcomes include patient-reported lifestyle behaviors, and quality of life.
Results:
Program planning began December 2024. Following the planning year, individual intake visits began on January 12, 2026, with group medical visits starting February 12, 2026. As of May 2026, the program has received over 2,200 referrals, scheduled 840 intake appointments, and enrolled 315 participants. Study results will be published separately.
Conclusions:
Based on the results of prior intensive lifestyle interventions, our team expects results to yield meaningful improvements in clinical and patient-reported outcomes. Findings will also generate insights into program adoption, fidelity, and sustainability in a large, multistate health system, and inform strategies to address common challenges associated with retention and program access. This study aims to add to the existing evidence base, demonstrating how a comprehensive lifestyle medicine intervention can be integrated into health systems at scale, supporting both clinical effectiveness and long-term sustainability.
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