Complete Lifestyle Medicine Intervention Program

NCT ID: NCT06192251

Last Updated: 2024-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-06

Study Completion Date

2026-11-06

Brief Summary

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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

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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)

Conditions

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High Cholesterol Diabetes Obesity Hypertension Heart Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Weekly classes of pillars of lifestyle medicine, monthly sessions with dietician, Lifestyle Medicine physician,kinesiologist and health coach

Lifestyle Medicine

Intervention Type BEHAVIORAL

Education and support for lifestyle modification to improve health conditions

Interventions

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Lifestyle Medicine

Education and support for lifestyle modification to improve health conditions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Healthy participants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Ontario School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lisa Allen

Research Coordinator, Director of Reserach, Parry Sound, Huntsville and Bracebridge

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline Rheaume, MD

Role: STUDY_CHAIR

Laval

Locations

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West Parry Sound Health Centre

Parry Sound, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Lisa Allen, PhD

Role: CONTACT

7056622901

Facility Contacts

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Mylene Juneau, MN

Role: primary

705-746-9321

References

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Patel K, Allen L, Boucher K, Fedele M, Fong D, Kumar S, Lavigne D, Marin-Couture E, Partyka-Sitnik M, Rietze N, Smith-Turchyn J, Juneau M, Rheaume C. Complete Lifestyle Medicine Intervention Program-Ontario: Implementation Protocol for a Rural Study. JMIR Res Protoc. 2024 Dec 31;13:e59179. doi: 10.2196/59179.

Reference Type DERIVED
PMID: 39740215 (View on PubMed)

Other Identifiers

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CLIP

Identifier Type: -

Identifier Source: org_study_id

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