Complete Lifestyle Medicine Intervention Program, Ontario (CLIP-ON): Protocol for Feasibility of Virtual and In-Person Rural Study. (Preprint)

BACKGROUND Sedentary lifestyles, poor nutritional choices, inadequate sleep, risky substance use such as alcohol and tobacco, fewer positive relationships, and increased stress are all contributing factors to the all-time high prevalence of chronic disease in society. The positive impact of incorporating all six pillars of lifestyle medicine on several chronic conditions was the driving force behind the development of this implementation study. To our knowledge, this is the first rural virtual and in-person lifestyle medicine program in Ontario, which is adapted from the successful lifestyle medicine program launched in 2019 at New York Health and Hospitals. OBJECTIVE This pilot study aims to assess the feasibility of establishing a comprehensive virtual and in-Person lifestyle medicine program for patients with chronic diseases in the Parry Sound area. METHODS Participants who want to join the Complete Lifestyle Medicine Intervention Program - Ontario (CLIP-ON) can self-refer or be referred by their healthcare provider. The intensive phase occurs in groups of five to fifteen participants who receive individual virtual or in-person care from one of the interdisciplinary team (physician, health coach, registered dietician, and kinesiologist) every two weeks over the six months. Anthropometric and cardiometabolic variables such as BMI, blood pressure, HbA1c and cholesterol are used to assess each participant before, at three months (midway), and immediately after completing the program. Participants are surveyed for lifestyle habits, wellness, perceived barriers, program satisfaction and qualitative feedback at three- and six- months. Feasibility will be assessed by investigation of participant recruitment, retention, acceptability, adoption, attendance rate to the lifestyle medicine classes, drop-out rate (and reasons), participant satisfaction, appropriateness, feasibility, fidelity, implementation cost, coverage, and sustainability. Additional qualitative feedback will be collected via separate participant and provider focus groups led by a qualitative research expert. RESULTS Patient recruitment began in September 2023. Eight eligible participants are included in the first cohort which is scheduled to be complete by April 2024. Quantitative and qualitative feedback will be collected from participants and providers to inform about the feasibility and impact of the study. Recruitment for the second cohort will begin in March 2024. This study was approved by the Laurentian University Research Ethics Board (6021397) on July 6, 2023, and is registered with ClinicalTrials.gov (NCT06192251). CONCLUSIONS The quantitative and qualitative evaluation of the virtual and in-person CLIP in this study will enable assessment of the program’s impact on psychological and physical health. Combined with the identification of key program barriers and opportunities, design enhancements can be informed to establish a template program inclusive of all ages and cultural backgrounds for other rural communities interested in novel virtual and in-person lifestyle medicine interventions. The piloting of this project will also provide opportunities to establish new collaborations with the local public health office, other existing programs, and non-profit organizations. CLINICALTRIAL NCT06192251