Complete Lifestyle Medicine Intervention Program-Ontario: Implementation Protocol for a Rural Study

Background: Sedentary lifestyles, poor nutritional choices, inadequate sleep, risky substance use, limited social connections, and high stress contribute to the growing prevalence of chronic diseases. Lifestyle medicine, emphasizing therapeutic lifestyle changes for prevention and treatment, has demonstrated effectiveness but remains underutilized in clinical settings. The Complete Lifestyle Medicine Intervention Program-Ontario (CLIP-ON) was developed to educate the rural population of Northern Ontario in lifestyle medicine to improve health outcomes and engagement.

Objective: This study evaluates the implementation and effectiveness of the CLIP-ON program for patients with chronic diseases in the Parry Sound area, focusing on lifestyle behaviors, health outcomes, enrollment, retention rates, and interdisciplinary team engagement.

Methods: This observational cohort study guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) includes pre- and postintervention assessments from participants and health care providers. A hybrid type II mixed methods design evaluates the intervention's effectiveness and implementation process in real-world settings through quantitative and qualitative data collection. CLIP-ON is tailored to the residents of the Parry Sound catchment area in Northern Ontario. Participants (≥18 years old) with chronic conditions such as prediabetes, type II diabetes, systemic hypertension, cardiovascular vascular disease, dyslipidemia, or high BMI (≥25) will be recruited through self-referral or provider referral. Approximately 10 participants per cohort will be enrolled in the CLIP-ON program, consisting of 22 weeks of weekly group sessions and monthly individual consultations with physicians, health coaches, kinesiologists, and registered dieticians either in person or through a web-based platform. CLIP-ON will cover the 6 pillars of lifestyle medicine through 14 group sessions followed by an 8-week supervised exercise program. Anthropometric and cardiometabolic variables will be measured before and after the program. Participants will be surveyed on lifestyle habits, wellness, perceived barriers, and program satisfaction at 3 and 6 months. Focus groups and dropout interviews with participants (n=10 per cohort) and providers (n=6 per cohort) will guide program adaptations. Quantitative and qualitative data collected at baseline and follow-up will assess the program's implementation and identify barriers and opportunities for improvement.

Results: This study was approved by the Laurentian University Research Ethics Board (6021397) on July 6, 2023. The first cohort was enrolled in late 2023 and is still under evaluation. The second cohort began in mid-2024, and data collection is currently underway. A mixed methods analysis will be used at enrollment, program completion (22 weeks), and follow-up (6 months after program completion). Focus groups assessing the program's effectiveness and implementation will take place after the 22-week intervention. Data will be analyzed in early 2025.

Conclusions: This protocol provides insights into the implementation of this lifestyle medicine program and its impact on participants' health. The findings will guide future advancements and establish a scalable model for other communities.

Trial registration: ClinicalTrials.gov NCT06192251; https://clinicaltrials.gov/study/NCT06192251.

International registered report identifier (irrid): DERR1-10.2196/59179.