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Recruiting

NCT Number: NCT06192251

Complete Lifestyle Medicine Intervention Program

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Parry Sound Health Centre

Parry Sound, Ontario, P2A3A4, Canada

Location status: Recruiting

Location contact

Caroline Rheaume, MD

SUB_INVESTIGATOR

Kush Patel, MSc

SUB_INVESTIGATOR

Mylene Juneau, MD

PRINCIPAL_INVESTIGATOR

Mylene Juneau, MN

CONTACT

[email protected]

705-746-9321

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Healthy participants

Treatment and study plan

Lifestyle Medicine

Behavioral

Education and support for lifestyle modification to improve health conditions

Primary outcomes

  1. 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)

  2. Participant Feedback

    Time frame: 1 month

    Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (The Well-being Assessment Survey)

  3. Participant Feedback

    Time frame: 1 month

    Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (Lifestyle Medicine Survey)

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Allen, PhD

CONTACT

[email protected]

7056622901

Sponsors and collaborators

Lead sponsor

Northern Ontario School of Medicine

Other

Registry information

Official study title

Complete Lifestyle Medicine Intervention Program (CLIP)

Acronym: CLIP

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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