Clinical trial NCT06192251: Complete Lifestyle Medicine Intervention Program
Official title: Complete Lifestyle Medicine Intervention Program (CLIP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Cholesterol
Diabetes
Obesity
Hypertension
Heart Diseases
Lead sponsor: Northern Ontario School of Medicine
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Healthy participants

Primary outcomes:
measure: Participant Feedback
timeFrame: 1 month
measure: Participant Feedback
timeFrame: 1 month
measure: Participant Feedback
timeFrame: 1 month
Secondary outcomes:
measure: Participant Feedback
timeFrame: 6 months
Other outcomes:
Locations:
city: Parry Sound
country: Canada
facility: West Parry Sound Health Centre
state: Ontario
Study officials:
affiliation: Laval
name: Caroline Rheaume, MD
role: STUDY_CHAIR
References: