Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06192251
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Complete Lifestyle Medicine Intervention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-11-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Feedback', 'timeFrame': '1 month', 'description': '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)'}, {'measure': 'Participant Feedback', 'timeFrame': '1 month', 'description': 'Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (The Well-being Assessment Survey)'}, {'measure': 'Participant Feedback', 'timeFrame': '1 month', 'description': 'Collect pre-and post intervention survey responses using the validated Lifestyle Medicine Scales (Lifestyle Medicine Survey)'}], 'secondaryOutcomes': [{'measure': 'Participant Feedback', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Cholesterol', 'Diabetes', 'Obesity', 'Hypertension', 'Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '39740215', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe eligibility criteria for participation in the lifestyle medicine program include adults with chronic diseases such as\n\n* prediabetes,\n* type 2 diabetes,\n* pre-hypertension,\n* systemic hypertension,\n* heart disease, dyslipidemia,\n* and/or excess weight (BMI ≥ 25 (42)).\n\nPatients 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:\n\nParticipants 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prediabetes,\n* type 2 diabetes,\n* pre-hypertension,\n* systemic hypertension,\n* heart disease, dyslipidemia,\n* and/or excess weight (BMI ≥ 25 (42)).\n\nExclusion Criteria:\n\n* Healthy participants'}, 'identificationModule': {'nctId': 'NCT06192251', 'acronym': 'CLIP', 'briefTitle': 'Complete Lifestyle Medicine Intervention Program', 'organization': {'class': 'OTHER', 'fullName': 'Northern Ontario School of Medicine'}, 'officialTitle': 'Complete Lifestyle Medicine Intervention Program (CLIP)', 'orgStudyIdInfo': {'id': 'CLIP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Weekly classes of pillars of lifestyle medicine, monthly sessions with dietician, Lifestyle Medicine physician,kinesiologist and health coach', 'interventionNames': ['Behavioral: Lifestyle Medicine']}], 'interventions': [{'name': 'Lifestyle Medicine', 'type': 'BEHAVIORAL', 'description': 'Education and support for lifestyle modification to improve health conditions', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P2A3A4', 'city': 'Parry Sound', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mylene Juneau, MN', 'role': 'CONTACT', 'email': 'mylene@whole-health.ca', 'phone': '705-746-9321'}, {'name': 'Mylene Juneau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caroline Rheaume, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kush Patel, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'West Parry Sound Health Centre', 'geoPoint': {'lat': 45.34732, 'lon': -80.03527}}], 'centralContacts': [{'name': 'Lisa Allen, PhD', 'role': 'CONTACT', 'email': 'lisa.allen@mahc.ca', 'phone': '7056622901'}], 'overallOfficials': [{'name': 'Caroline Rheaume, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Deidentified data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Ontario School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator, Director of Reserach, Parry Sound, Huntsville and Bracebridge', 'investigatorFullName': 'Lisa Allen', 'investigatorAffiliation': 'Northern Ontario School of Medicine'}}}}