Patel Kush, Allen Lisa, Boucher Karine, Fedele Michelle, Fong Debbie, Kumar Sangeeta, Lavigne Deanna, Marin-Couture Elisa, Partyka-Sitnik Magdalena, Rietze Nicole, Smith-Turchyn Jenna, Juneau Mylene, Rhéaume Caroline
Northern Ontario School of Medicine University, Sudbury, ON, Canada.
Parry Sound Local Education Group, Parry Sound, ON, Canada.
JMIR Res Protoc. 2024 Dec 31;13:e59179. doi: 10.2196/59179.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT06192251; https://clinicaltrials.gov/study/NCT06192251.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59179.
久坐不动的生活方式、不良的营养选择、睡眠不足、危险物质的使用、有限的社交联系以及高压力导致慢性病的患病率不断上升。生活方式医学强调通过治疗性的生活方式改变来预防和治疗疾病，已证明其有效性，但在临床环境中仍未得到充分利用。安大略省完整生活方式医学干预项目（CLIP-ON）旨在对安大略省北部农村人口进行生活方式医学教育，以改善健康结果并提高参与度。
本研究评估CLIP-ON项目在帕里桑德地区慢性病患者中的实施情况和效果，重点关注生活方式行为、健康结果、注册率、留存率以及跨学科团队的参与度。
这项以RE-AIM框架（覆盖范围、有效性、采用率、实施情况和维持情况）为指导的观察性队列研究包括参与者和医疗服务提供者的干预前和干预后评估。一种混合式II型混合方法设计通过定量和定性数据收集来评估该干预措施在现实环境中的有效性和实施过程。CLIP-ON是为安大略省北部帕里桑德集水区的居民量身定制的。患有前驱糖尿病、II型糖尿病、系统性高血压、心血管疾病、血脂异常或高体重指数（≥25）等慢性病的参与者（≥18岁）将通过自我推荐或提供者推荐的方式招募。每个队列大约有10名参与者将参加CLIP-ON项目，该项目包括为期22周的每周小组会议以及每月与医生、健康教练、运动生理学家和注册营养师进行的个人咨询，咨询方式可以是面对面的，也可以通过网络平台进行。CLIP-ON将通过14次小组会议涵盖生活方式医学的6个支柱，随后是一个为期8周的监督运动项目。在项目前后将测量人体测量和心脏代谢变量。将在3个月和6个月时对参与者进行生活方式习惯、健康状况、感知障碍和项目满意度的调查。与参与者（每个队列10人）和提供者（每个队列6人）进行焦点小组讨论和退出访谈将指导项目的调整。在基线和随访时收集的定量和定性数据将评估项目的实施情况，并确定改进的障碍和机会。
本研究于2023年7月6日获得劳伦森大学研究伦理委员会（6021397）的批准。第一个队列于2023年末入组，目前仍在评估中。第二个队列于2024年年中开始，目前正在进行数据收集。将在入组、项目完成（22周）和随访（项目完成后6个月）时使用混合方法分析。在为期22周的干预结束后，将进行评估项目有效性和实施情况的焦点小组讨论。数据将于2025年初进行分析。
本方案提供了对该生活方式医学项目实施情况及其对参与者健康影响的见解。研究结果将指导未来的进展，并为其他社区建立一个可扩展的模式。
ClinicalTrials.gov NCT******；https://clinicaltrials.gov/study/NCT******。
国际注册报告识别码（IRRID）：DERR1-10.2196/59179。 （注：原文中ClinicalTrials.gov的编号未完整给出，翻译时保留原文格式）
