High CholesterolCLIPNCT06192251
Complete Lifestyle Medicine Intervention Program
An observational study of High Cholesterol and Diabetes, run by Northern Ontario School of Medicine at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Cholesterol, Diabetes, Obesity
- What is being tested?
- Lifestyle Medicine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2023to 6 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- prediabetes,
- type 2 diabetes,
- pre-hypertension,
- systemic hypertension,
- heart disease, dyslipidemia,
- and/or excess weight (BMI ≥ 25 (42)).
Who cannot join
- Healthy participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
West Parry Sound Health Centre
Parry Sound, Ontario, P2A3A4
Mylene Juneau, MN, 705-746-9321, mylene@whole-health.ca
Mylene Juneau, MD
About this study
Official title: 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.
Read the 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)
- Conditions
- High Cholesterol, Diabetes, Obesity, Hypertension, Heart Diseases
- Being tested
- Lifestyle Medicine
- Medical subject headings
- Hypercholesterolemia, Diabetes Mellitus, Obesity, Hypertension, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle MedicineBehavioural
Education and support for lifestyle modification to improve health conditions
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Weekly classes of pillars of lifestyle medicine, monthly sessions with dietician, Lifestyle Medicine physician,kinesiologist and health coach Receives: Behavioral: Lifestyle Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Participant Feedback
Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (The Well-being Assessment Survey)
Measured: 1 month
Participant Feedback
Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (Lifestyle Medicine Survey)
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start6 Nov 2023
- Primary completion6 Aug 2025 (estimated)
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Ontario School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Allen, Northern Ontario School of Medicine
- Investigators
- Caroline Rheaume, MD, Study chair, Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192251
- Sponsor's protocol ID
- CLIP
- Acronym
- CLIP
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data will be shared
Publications
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.
PubMed 39740215
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Lifestyle Medicine Intervention Program (CLIP)
- ClinicalTrials.gov ID
- NCT06192251
- Acronym / sponsor ID
- CLIP / CLIP
- Conditions
- High Cholesterol, Diabetes, Obesity, Hypertension, Heart Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Northern Ontario School of MedicineUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 6 Aug 2025 (estimated)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Behavioral: Lifestyle MedicineWeekly classes of pillars of lifestyle medicine, monthly sessions with dietician, Lifestyle Medicine physician,kinesiologist and health coach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- prediabetes,
- type 2 diabetes,
- pre-hypertension,
- systemic hypertension,
- heart disease, dyslipidemia,
Key exclusion criteria (1 listed)
- Healthy participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle MedicineEducation and support for lifestyle modification to improve health conditions | Behavioural | Cohort 1 |
Primary outcome
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)
Participant Feedback
Time frame: 1 month
Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (The Well-being Assessment Survey)
Participant Feedback
Time frame: 1 month
Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (Lifestyle Medicine Survey)
1 secondary outcome
Participant Feedback
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Derived from this study: PubMed 39740215Patel 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.
- Individual participant dataSharing planned: Undecided. Deidentified data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Rheaume, MD study chair
Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Cholesterol and Diabetes, run by Northern Ontario School of Medicine at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Allen, PhD (7056622901, lisa.allen@mahc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Feedback (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.