Complete Lifestyle Medicine Intervention Program

Obesity Clinical Trial

— CLIP  

Official title:

Complete Lifestyle Medicine Intervention Program (CLIP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192251
• Other study ID #: CLIP
• Status: Recruiting
• 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
• 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: November 6, 2026
• Est. primary completion date: August 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• prediabetes,

• type 2 diabetes,

• pre-hypertension,

• systemic hypertension,

• heart disease, dyslipidemia,

• and/or excess weight (BMI = 25 (42)).

Exclusion Criteria:

• Healthy participants

Related Conditions & MeSH terms

• Diabetes
• Heart Diseases
• High Cholesterol
• Hypercholesterolemia
• Hypertension
• Obesity

Intervention

Behavioral:
• Lifestyle Medicine
Education and support for lifestyle modification to improve health conditions

Locations

Country	Name	City	State
Canada	West Parry Sound Health Centre	Parry Sound	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Northern Ontario School of Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Feedback	Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (The Lifestyle Assessment Short Form) and The Well-being Assessment and Lifestyle Medicine Survey)	1 month
Primary	Participant Feedback	Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (The Well-being Assessment Survey)	1 month
Primary	Participant Feedback	Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (Lifestyle Medicine Survey)	1 month
Secondary	Participant Feedback	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.	6 months