Complete Lifestyle Medicine Intervention Program

Recruiting

• Conditions: High Cholesterol; Diabetes; Obesity; Hypertension; Heart Diseases
• Interventions: Behavioral: Lifestyle Medicine

• Registration Number: NCT06192251
• Lead Sponsor: Northern Ontario School of Medicine

Brief Summary

This project will use a mixed design and will be conducted at the West Parry Sound Health Centre. Based on similar studies there is an expected 10% drop-out rate so 20 participants per group will be invited to aim to have 15 finish. Total participants invited over the two-year study will be 40. The participants will be followed over a Complete 6-month Lifestyle medicine Intervention Program (CLIP) involving a collaboration between physicians, health coach, registered dietitians, and kinesiology. The CLIP will cover the 6 pillars of lifestyle medicine in 12-14 fundamentals of lifestyle medicine group classes.

Detailed Description

Participants will have the option of a hybrid platform to ensure equal access. Participants will attend (virtually or in person) a weekly lecture on Lifestyle Medicine Pillars for 16 weeks followed by a weekly exercise program for 8 weeks. This program was inspired by the research team of Albert et al 2022.

The eligibility criteria for participation in the lifestyle medicine program include adults with chronic diseases such as

* prediabetes,

* type 2 diabetes,

* pre-hypertension,

* systemic hypertension,

* heart disease, dyslipidemia,

* and/or excess weight (BMI ≥ 25 (42)).

Patients will be invited through referral by their physicians, email by local heart disease and diabetes foundation, mail-out by nurse practitioner and community health teams. Metrics:

Participants will be evaluated using validated pre-and post intervention validated surveys provided by the American College of Lifestyle Medicine, The Lifestyle Assessment Short Form. Added to the validated survey included questions on demographic characteristics including gender, age, race and ethnicity, language use, education, health insurance marital status. Participants will complete The Well-being Assessment and Lifestyle Medicine Survey (American College of Lifestyle Medicine)

Study Timeline

• Study Start: 2023-11-06
• Study First Submitted: 2023-12-15
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-08
• Primary Completion: 2025-08-06
• Study Completion: 2026-11-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• prediabetes,
• type 2 diabetes,
• pre-hypertension,
• systemic hypertension,
• heart disease, dyslipidemia,
• and/or excess weight (BMI ≥ 25 (42)).

Exclusion Criteria

• Healthy participants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Lifestyle Medicine	Weekly classes of pillars of lifestyle medicine, monthly sessions with dietician, Lifestyle Medicine physician,kinesiologist and health coach

Primary Outcome Measures

Name	Time	Method
Participant Feedback	1 month	Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (Lifestyle Medicine Survey)

Secondary Outcome Measures

Name	Time	Method
Participant Feedback	6 months	Participants will be invited to participate in focus groups at the end of the 22 week intervention to share their opinions about the material covered, how the study could be improved and general feedback.

Trial Locations

Locations (1)

West Parry Sound Health Centre; 🇨🇦 Parry Sound, Ontario, Canada