Complete Lifestyle Medicine Intervention Program (CLIP)

January 4, 2024 updated by: Lisa Allen, Northern Ontario School of Medicine

Complete Lifestyle Medicine Intervention Program (CLIP)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Parry Sound, Ontario, Canada, P2A3A4
        • Recruiting
        • West Parry Sound Health Centre
        • Contact:
        • Principal Investigator:
          • Mylene Juneau, MD
        • Sub-Investigator:
          • Caroline Rheaume, MD
        • Sub-Investigator:
          • Kush Patel, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Weekly classes of pillars of lifestyle medicine, monthly sessions with dietician, Lifestyle Medicine physician,kinesiologist and health coach
Behavioral: Lifestyle Medicine
Education and support for lifestyle modification to improve health conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Feedback
Time Frame: 1 month
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
Participant Feedback
Time Frame: 1 month
Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (The Well-being Assessment Survey)
1 month
Participant Feedback
Time Frame: 1 month
Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (Lifestyle Medicine Survey)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Feedback
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Ontario School of Medicine

Investigators

  • Study Chair: Caroline Rheaume, MD, Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

August 6, 2025

Study Completion (Estimated)

November 6, 2026

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Deidentified data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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