NCT06192251

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2023Nov 2026

Study Start

First participant enrolled

November 6, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2026

Expected
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

December 15, 2023

Last Update Submit

January 4, 2024

Conditions

High CholesterolDiabetesObesityHypertensionHeart Diseases

Outcome Measures

Primary Outcomes (3)

  • 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

  • Participant Feedback

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

    1 month

  • Participant Feedback

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

    1 month

Secondary Outcomes (1)

  • Participant Feedback

    6 months

Study Arms (1)

Cohort 1

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

Behavioral: Lifestyle Medicine

Interventions

Lifestyle MedicineBEHAVIORAL

Education and support for lifestyle modification to improve health conditions

Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Healthy participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Parry Sound Health Centre

Parry Sound, Ontario, P2A3A4, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39740215DERIVED

MeSH Terms

Conditions

HypercholesterolemiaDiabetes MellitusObesityHypertensionHeart Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Caroline Rheaume, MD

    Laval

    STUDY CHAIR

Central Study Contacts

Lisa Allen, PhD

CONTACT

7056622901lisa.allen@mahc.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator, Director of Reserach, Parry Sound, Huntsville and Bracebridge

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 5, 2024

Study Start

November 6, 2023

Primary Completion

August 6, 2025

Study Completion (Estimated)

November 6, 2026

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

CA(1)