Chronic diseases, also known as noncommunicable diseases (NCDs) such as cancer, cardiovascular disease, cerebrovascular disease, and diabetes, are among the leading causes of death in Canada, with their prevalence steadily rising [1]. Hypertension, the leading global risk factor for death and disability, remains uncontrolled in more than 50% of patients [2]. NCDs are responsible for over 74% of global deaths annually [2-4], significantly affecting vulnerable and low-income populations [5-7]. Despite clear benefits from improved lifestyle choices, including better nutrition, regular physical activity, and stress reduction, there remains limited research on the long-term sustainability of these changes and the role of physician intervention [5,7-9].

Sedentary lifestyles, poor nutritional choices, and increased stress play significant roles in chronic disease development [7,8,10], with type II diabetes affecting over 10% of the population worldwide [11]. Type II diabetes, primarily linked to cardiovascular disease, contributes to over 1 million deaths annually [7,12-14]. Chronic disease–related health care costs in Canada account for more than US $136 billion annually [15], emphasizing the need for lifestyle interventions to reduce this burden [1,14].

Lifestyle medicine is an interdisciplinary medical specialty that focuses on 6 key pillars such as dietary changes, regular physical activity, stress management, restorative sleep, positive social connection, and avoidance of risky substances such as alcohol and tobacco has been shown to improve outcomes in chronic conditions [16-18]. Moreover, with its patient-centered focus [6,19-21], lifestyle medicine addresses the root causes of disease, aligning with the P4 (Preventive, Predictive, Personalized, and Participatory) medicine approach [6,22,23]. Achieving optimal health through a maintained commitment to lifestyle medicine has been shown to reverse many stages of chronic disease, reduce hospitalization and hospital costs, improve chronic disease management, and promote better health outcomes [4,5,14,24-28].

Studies indicate that the adoption of evidence-based lifestyle medicine practices has gained traction, with numerous programs demonstrating effectiveness in improving health outcomes and promoting sustainable behavior change [9,29-31]. Other studies support the adoption of evidence-based lifestyle medicine practices across North America [9,20,32,33]. Such evidence highlights the potential for lifestyle medicine to be integrated into routine health care, paving the way for broader acceptance and implementation in various clinical environments.

However, despite these promising outcomes, effective implementation of lifestyle medicine in clinical settings remains challenging. A strong patient-provider collaborative relationship is essential for achieving adherence to treatment plans and informed health care decision-making [34]. The physician’s role as a health coach is critical in this process, underscoring the importance of training clinicians in lifestyle medicine practices [5,12,16,35]. Yet, many physicians report a lack of confidence and skills in delivering lifestyle medicine effectively [20], especially in rural areas. During the COVID-19 pandemic, virtual and digital platforms, such as lifestyle management tools, were developed to support patients [10,36], which has proven to be crucial for equitable health care access [16,35]. These tools hold the potential to address barriers in underserved areas where health care resources are limited, particularly in rural settings.

In this context, it becomes essential to evaluate the real-world implementation of lifestyle medicine to identify both successes and challenges, ensuring that lifestyle medicine can be effectively integrated into routine health care. This is especially relevant in rural areas, where health care access is limited, and the burden of chronic disease is high. Parry Sound, a rural community in Northern Ontario with a population of 6879 and a catchment area of 42,824 (including 10% Indigenous residents) [26,29,36,37], experiences disproportionately high rates of diabetes (8%) and hypertension (20%) compared with the provincial average [27]. These factors make it an ideal location for integrating lifestyle medicine into care. Incorporating traditional Indigenous teachings, which emphasize the interconnectedness of mind, body, spirit, and emotions, can bridge gaps between traditional Western medicine and Indigenous Healing Practices and improve population health outcomes [28,36,38].

Inspired by the New York Lifestyle Medicine program [36,38], in 2023 our medical and research team, in collaboration with the health care community in Parry Sound, developed an innovative and whole health program named the Complete Lifestyle medicine Intervention Program, Ontario (CLIP-ON). These comprehensive interdisciplinary aims are to educate participants on the 6 pillars of lifestyle medicine and inform them about their integration into daily life to mitigate chronic disease and enhance overall health. To facilitate the implementation of lifestyle medicine practices, various models and methodologies have been proposed [39]. Among these, the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) serves as a valuable tool for evaluating the impact of lifestyle medicine interventions in diverse settings [40,41]. To the best of our knowledge, this is the first program in lifestyle medicine in a rural area in Ontario. Our overarching hypothesis is that the implementation of CLIP-ON will significantly improve lifestyle behavior, health outcomes, and participant engagement, with feedback from participants and health care providers informing real-time program improvements.

To evaluate the implementation and effectiveness of the comprehensive web-based platform and in-person CLIP-ON program for patients with chronic disease in the Parry Sound area, focusing on its impact on lifestyle behaviors, health outcomes including cardiometabolic parameters, and participants’ engagement.

The secondary objectives of this study are (1) to assess the reach and adoption of the CLIP-ON program by evaluating participant enrollment, and retention rates and (2) to gather and analyze direct feedback from participants and health care providers to inform real-time program improvements and enhance the program’s overall effectiveness.

This protocol outlines an observational cohort study guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and includes pre- and postintervention assessments from participants and health care providers (RE-AIM milestones Multimedia Appendix 1). A hybrid design type II mixed methods approach [42,43] will be used to simultaneously evaluate both the effectiveness of the CLIP-ON and its implementation process in a real-world setting. This will involve the collection and analysis of both quantitative and qualitative data.

The CLIP-ON program is an interdisciplinary lifestyle medicine intervention delivered both virtually and in person, specifically tailored for residents of the Parry Sound catchment area in Northern Ontario. Within this district are 3 First Nation Communities (Wasauksing, Moose Deer Point, and Shawanaga First Nations), each of which has requested access to CLIP-ON. The study design is summarized in Figure 1, and the participant’s and health care providers’ measurements are presented in Table 1. Following informed consent, each participant will have an initial appointment with a certified lifestyle medicine physician at West Parry Sound Health Centre before starting the CLIP-ON program. Participants will complete the Physical Activity Readiness Questionnaire (PAR-Q+) by the Canadian Society of Exercise Physiology [44] to identify risk factors during moderate physical activity. A Physical Activity Readiness Medical Examination (PARmed-X) [45] will also be completed for participants who had potential medical complications from exercise according to their response to the PAR-Q+. During this visit, they will undergo a medical review and physical examination. They will also receive a requisition for blood work to establish their baseline cardiometabolic data. Each participant will complete a baseline (intake Lifestyle and health) questionnaire on Google Forms with the assistance of a trained research staff member over the phone. This preprogram questionnaire will collect demographic and baseline information about their lifestyle according to the 6 pillars of lifestyle medicine. Cardiometabolic variables will be measured before and after the CLIP-ON intervention. Participants will be surveyed by phone at 3- and 6-months regarding lifestyle habits, wellness, perceived barriers, and program satisfaction. At the end of the program, web-based platform (through Zoom) focus groups with participants and health care providers will be conducted to discuss their experiences and provide feedback for program development. Focus groups and dropout interviews with patients (approximately 10 per cohort, anticipating a drop-out rate of 10% based on similar studies [29], and providers (approximately 6 per cohort) will provide iterative feedback, enabling program refinement. The 2 cohorts are planned, with potential for expansion based on the available funding. The study timeline is illustrated in Figure 2.

Figure 1 demonstrates participant flow throughout the CLIP-ON study, a hybrid lifestyle medicine program designed for rural Northern Ontario. The program addresses 6 pillars of health: healthy nutrition, regular physical activity, restorative sleep, stress management, avoiding risky substance use, and fostering positive relationships. Patients could meet health care providers in person or through a web-based platform. Group sessions and exercise classes during the 22-week program were available in 3 formats: in person, through a web-based platform, or as recorded sessions for later access. Intake lifestyle and health progress questionnaire inspired by the Lifestyle Assessment Short Form [46], the short form survey instrument SF-36 and the PHQ-9 [47,48]. Physical Activity Readiness Questionnaire: PAR-Q+ [44] and PARmed-X [45]. Three- and 6-Month Health Progress Questionnaire inspired by the questions used in the New York City Health [38,49,50] and Hospital Lifestyle Medicine program and the CHIP lifestyle medicine program at Vanderbilt University [51,52].

Participants will be recruited through self-referral or referral by health care providers. Multiple avenues will be pursued to enhance recruitment efforts and reach a diverse population. Posters will be distributed throughout the Parry Sound community in high-traffic public locations such as grocery stores, coffee shops, libraries, and various departments within the Parry Sound Community Hospital. Pamphlets will be made available at health care provider clinics both within and outside of the hospital, including the Family Health Team and nurse-practitioner-led clinics. In addition, both posters and pamphlets will be distributed to local health care providers, who will be encouraged to share on social media (Facebook and Instagram [Meta]) in accordance with the ethical agreement to maximize outreach to the target population. These comprehensive recruitment strategies aim to ensure saturation of the rural environment and ensure equal opportunities for eligible participants to join the program.

The CLIP-ON implementation assessment is guided by the RE-AIM framework which defines 5 dimensions: reach, effectiveness, adoption, implementation, and maintenance [40,41]. These dimensions will also help guide enhancements to the CLIP-ON program. Further details are provided in Multimedia Appendix 1.

This study received ethics approval from the Laurentian University Research Ethics Board (6021397) on July 6, 2023, and adheres to the guidelines stated in the Declaration of Helsinki. This study was registered at ClinicalTrials.gov (NCT06192251) in November 2023. Trained research staff informed participants of their right to withdraw themselves and the information collected on them up until the time of withdrawal, and informed consent was obtained. Patient data is available only to program health care providers and is segregated from research data. Participants are assigned a research code following the informed consent process, which links their research data through the study to allow appropriate analyses. Participant information is deidentified, and results will be published in this manner as well to ensure confidentiality.

We anticipate that these findings will support the long-term goal of establishing a lifestyle medicine program for rural Ontario communities that combines education, digital platforms, and interactions with an interdisciplinary health team. Its holistic, patient-centered approach to medicine strives to promote lifestyle changes that can prevent and treat chronic diseases, transform patient care in a manner that has been demonstrated to be successful in large urban centers and encourage its adoption and adaptation by health care providers across Canada. Our long-term goal is to demonstrate that CLIP-ON positively impacts community health and decreases health care use by reducing the impact of chronic illness.

CLIP-ON is the first lifestyle medicine program that will be conducted virtually and in-person in a rural Canadian community setting, while other Canadian lifestyle medicine interventions, such as Canadian Health Advanced Nutrition for Graded Exercise (CHANGE), have been implemented in large primary care settings in a physical format only [9,33]. This study will investigate the impact of incorporating all 6 pillars of lifestyle medicine as opposed to selected pillars [49-52,55-58]. It is also designed for patients with broad chronic diseases compared to other lifestyle medicine studies that focus on patients with specific chronic diseases [57,59-61]. Like the New York City lifestyle medicine program, CLIP-ON is built around all 6 pillars of health while providing individual support, goal setting, dietary recommendations, and monitoring support of an interdisciplinary health team [29,30,38]. However, Parry Sound’s catchment area spans 9222 km² which is much larger than New York City’s 790-km² urban setting [26,62]. The Parry Sound region includes 8 municipalities and townships and 4 First Nation communities housing over 42,000 residents who sometimes must travel long distances to access just primary care [26]. Therefore, understanding the unique challenges faced by rural Ontario communities will allow modifications to the program design that will be considerate of socioeconomic status, geographic and transportation barriers, preexisting patient-physician relationships, and cultural diversity.

The ability for participants to attend all programming virtually and in person was a core design to enhance program accessibility. This hybrid structure will also allow the onboarding of health care providers located throughout the province to engage in CLIP-ON more easily. Considering the vast catchment area of Parry Sound, limited transportation methods, and financial disparity within the region, it is understood that all participants may not have or have access to weekly transportation for classes. The research team will assist in identifying patient transport services to facilitate participant attendance at key program sessions wherever possible to enhance accessibility. A preexisting patient-physician relationship may result in discomfort for either participants or providers or introduce biased treatment towards some participants. Therefore, the research team will ensure that participants are matched with providers that they do not have an existing professional relationship with. Finally, special considerations will be incorporated for local Indigenous populations to be inclusive and respect their cultural requirements, including a land acknowledgment before every session and including providers with related experience and understanding of individual challenges and cultural differences.

These design elements distinctly position CLIP-ON as a whole health program designed to help all patients incorporate changes in various aspects of their lives in a setting where a lifestyle medicine program has yet to be introduced and piloted.

CLIP-ON is the first lifestyle medicine program designed for rural communities in Ontario. This included extensive engagement with local health care providers and community members to understand their unique challenges and preferences. It incorporates specific design elements such as virtual programming, which increases program accessibility for patients facing geographic barriers so that they can attend classes, exercise sessions, and meetings with health care providers remotely. The hybrid delivery model provides flexibility, allowing patients to choose in-person or virtual participation, which is crucial for geographically isolated individuals. In addition, it enables the recruitment of remote health care providers, increasing the feasibility of building an interdisciplinary health team for the program. This flexibility offers CLIP-ON to be a sustainable, impactful, and scalable model of preventative health care.

The involvement of an interdisciplinary team of health care professionals, including physicians, dietitians, health coaches, and kinesiologists, provides a comprehensive care approach that addresses various facets of participants’ health, enhancing the likelihood of sustainable health improvements. Furthermore, the program’s use of the RE-AIM framework ensures that implementation is evaluated through a robust and credible scientific approach, facilitating future scalability and applicability to other regions.

Initial observations have noted that the group structure and interactions during lifestyle medicine classes and exercise sessions facilitate social connectedness within the first cohort. The program’s focus on peer support and social interaction has led to increased participant accountability, as individuals share challenges and strategies within the group setting. Research shows that this peer support is often key to maintaining long-term behavior change [63]. Finally, the 2-cohort design of this study enables efficient incorporation of feedback from cohort one to enhance the program design for cohort two. The patient-centered approach, which integrates real-time feedback from participants and health care providers through focus groups and surveys, ensures continuous refinement of the program to meet participants’ needs and further enhance satisfaction and engagement.

This study has some limitations. Parry Sound’s small core town population of 6879 combined with the geographic barriers associated with its vast catchment area and lack of public transit limited the initial recruitment to only 8 participants in the first cohort, as opposed to the anticipated 10-12 [25]. This small sample size may limit the statistical power of the study, making it difficult to establish significant findings that are generalizable to other rural communities. To mitigate this, we are actively exploring strategies such as broader outreach to health care providers within the catchment area and forming partnerships with community organizations to raise awareness of the program.

Initial feedback also suggests that some participants found the program duration of 6 months to be too short for achieving and maintaining meaningful lifestyle changes. Extending the program duration could allow participants more time to solidify lifestyle adjustments. In addition, longer follow-ups will support the long-term impact of lifestyle medicine on chronic disease management. To facilitate this, additional follow-up sessions and group support beyond the 6-month mark are being established to reinforce lifestyle habits. This could offer a more gradual transition toward self-management for participants.

The web-based platform, while increasing accessibility for most, may present technological barriers for older participants or those unfamiliar with using web-based platforms. This could potentially reduce engagement for certain segments of the population, especially if support for technology use is not adequately provided. To alleviate this, we have introduced a brief training session for participants on how to use the virtual platform, and technical support is now available throughout the program.

We plan to conduct a follow-up assessment at 12 months and beyond to evaluate the sustainability of lifestyle changes and improvements in health outcomes among participants to provide valuable insights into the long-term impact of the CLIP-ON program. We will also explore the possibility of scaling the CLIP-ON program to other rural communities in Northern Ontario, considering adaptations based on the unique needs and cultural contexts of those populations. We will collaborate with local Indigenous communities to incorporate traditional health practices and teachings into the CLIP-ON program. This integration may enhance cultural relevance and improve health outcomes among Indigenous participants. We also plan to investigate the use of mobile health applications and web-based platforms to enhance participant engagement and accessibility such as tools for tracking progress, providing education resources, and facilitating communication with health care providers.

The results of this study will be shared locally through grand round presentations and with the hospital senior team and board members. There is a commitment from West Parry Sound Health Centre to support this study, and findings are regularly shared with senior leadership, the local education group executive, local primary care provider family health teams, and the Parry Sound Ontario Health Team. We will provide the results of the findings to each of these groups in an appropriate presentation at their request. In addition, we will share the results through publication and presentation within our Northern Ontario School of Medicine University and through presentation at the annual research conference.

This protocol paper will provide valuable insights into the implementation of a lifestyle medicine program, which will be evaluated for its impact on participants’ health. The goal is to establish and disseminate an effective framework for secondary prevention, management, and in some cases reversal of common chronic diseases. By assessing the real-world implementation of this program, we aim to identify both successes and areas for improvement, ensuring the feasibility and sustainability of integrating lifestyle medicine into routine health care practices.

This comprehensive evaluation will not only guide future advancements in lifestyle medicine but also help establish a culturally inclusive and scalable model that can be adapted to benefit other communities, particularly those in resource-limited or rural settings.