Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06192251 |
Other study ID # |
CLIP |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 6, 2023 |
Est. completion date |
November 6, 2026 |
Study information
Verified date |
January 2024 |
Source |
Northern Ontario School of Medicine |
Contact |
Lisa Allen, PhD |
Phone |
7056622901 |
Email |
lisa.allen[@]mahc.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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)