JMIR Publications

ABSTRACT

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, which promotes therapeutic lifestyle changes to prevent and treat various chronic diseases, has shown positive results, but its implementation in clinical settings remains challenging. The Complete Lifestyle medicine Intervention Program - Ontario (CLIP-ON) was developed to educate the rural population of Northern Ontario about lifestyle medicine to improve health outcomes and participant engagement.

Objective:

To evaluate the implementation and effectiveness of the virtual and in-person CLIP-ON program for patients with chronic diseases in the Parry Sound area, focusing on its impact on lifestyle behaviors, health outcomes, participant enrollment and retention rates, and the engagement of healthcare providers within the interdisciplinary team.

Methods:

This observational cohort study guided by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) includes pre- and post-intervention assessments from the participants and healthcare providers. A hybrid Type 2 mixed-methods design will be employed to evaluate the effectiveness of the intervention and its implementation process in real-world settings, involving the collection and analysis of both quantitative and qualitative data. CLIP-ON is an interdisciplinary lifestyle medicine program that will serve as the intervention, delivered both virtually and in person, tailored to the residents of Parry Sound catchment area in Northern Ontario. Participants (≥18 years old) with chronic conditions such as prediabetes, type 2 diabetes, systemic hypertension, cardiovascular vascular disease, dyslipidemia, or high body mass index (BMI ≥ 25) will be recruited through self-referral or healthcare 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. CLIP-ON will cover the six 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 will be conducted with participants (n=10 per cohort) and providers (n=6 per cohort) to allow rapid program adaptation and improvement. Quantitative and qualitative data collected at baseline and follow-up will assess the program’s implementation, effectiveness, 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 of participants 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 method analyses will be used to analyze the quantitative and qualitative data, collected individually at enrollment, program completion (22 weeks), and follow-up (six 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 critical 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. Clinical Trial: ClinicalTrials.gov ID NCT06192251; https://clinicaltrials.gov/study/NCT06192251?term=NCT06192251&rank=1