Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:42 PM
Study NCT ID:
NCT05758857
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2023-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Risk Factor Intervention Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3-arm parallel-group randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-03-04', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '6 months', 'description': 'Assessed by RAND-36, where an independent score is provided for 8 scales ranging from 0 to 100 with a higher score indicating better quality of life'}, {'measure': 'Psychosocial stress', 'timeFrame': '6 months', 'description': 'assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress'}, {'measure': 'Intervention acceptability', 'timeFrame': '6 months', 'description': 'Assessed via researcher-developed questionnaire'}, {'measure': 'Menopausal symptom presence and severity', 'timeFrame': '6 months', 'description': 'assessed by The Menopause-specific Quality of Life (MENQOL) questionnaire. Each of four domains is constrained between 1 to 8 where a higher score indicates more symptoms.'}, {'measure': 'Dietary intake', 'timeFrame': '6 months', 'description': 'Assessed via ASA-24 3-day food records'}, {'measure': 'Depressive symptoms', 'timeFrame': '6 months', 'description': 'measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression'}, {'measure': 'Body circumferences', 'timeFrame': '6 months', 'description': 'Waist, hip and neck circumferences measured by inelastic tape'}, {'measure': 'Whole-body fat and fat free mass', 'timeFrame': '6 months', 'description': 'Measured by BodPod'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': '6 months', 'description': 'Measured as peak volume of oxygen consumption via indirect calorimetry'}, {'measure': 'Blood pressure', 'timeFrame': '6 months', 'description': 'Measured after several minutes of supine rest'}, {'measure': 'Physical activity intervention feasibility', 'timeFrame': '6 months', 'description': 'Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch'}, {'measure': 'Diet quality intervention feasibility', 'timeFrame': '6 months', 'description': 'Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record'}], 'primaryOutcomes': [{'measure': 'Physical activity intervention feasibility', 'timeFrame': 'end of week 6', 'description': 'Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch'}, {'measure': 'Diet quality intervention feasibility', 'timeFrame': 'end of week 6', 'description': 'Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record'}, {'measure': 'Intervention acceptability', 'timeFrame': 'end of week 6', 'description': 'Assessed via researcher-developed questionnaire'}], 'secondaryOutcomes': [{'measure': 'Systemic insulin resistance', 'timeFrame': '6 weeks', 'description': 'As assessed by the Matsuda Index calculated from an oral glucose tolerance test'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)', 'timeFrame': '6 weeks', 'description': 'calculated as: (fasting insulin\\*fasting glucose)/22.5'}, {'measure': 'Framingham 10-year risk (%)', 'timeFrame': '6 weeks', 'description': 'Calculated using standardized scoring system'}, {'measure': 'Lipid profile', 'timeFrame': '6 weeks', 'description': 'analyzed from blood'}, {'measure': 'C-Reactive Protein', 'timeFrame': '6 weeks', 'description': 'analyzed from blood'}, {'measure': 'Blood pressure', 'timeFrame': '6 weeks', 'description': 'Measured after several minutes of supine rest'}, {'measure': 'Aortic stiffness (central to femoral)', 'timeFrame': '6 weeks', 'description': 'Measured via Shygmacor device'}, {'measure': 'Brachial artery endothelial function', 'timeFrame': '6 weeks', 'description': 'Measured via flow-mediated dilatation test'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': '6 weeks', 'description': 'Measured as peak volume of oxygen consumption via indirect calorimetry'}, {'measure': 'Whole-body fat and fat free mass', 'timeFrame': '6 weeks', 'description': 'Measured by BodPod'}, {'measure': 'Body circumferences', 'timeFrame': '6 weeks', 'description': 'Waist, hip and neck circumferences measured by inelastic tape'}, {'measure': 'Depressive symptoms', 'timeFrame': '6 weeks', 'description': 'measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression'}, {'measure': 'Dietary intake', 'timeFrame': '6 weeks', 'description': 'Assessed via ASA-24 3-day food records'}, {'measure': 'Menopausal symptom presence and severity', 'timeFrame': '6 weeks', 'description': 'assessed by The Menopause-specific Quality of Life (MENQOL) questionnaire. Each of four domains is constrained between 1 to 8 where a higher score indicates more symptoms.'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 weeks', 'description': 'Assessed by RAND-36, where an independent score is provided for 8 scales ranging from 0 to 100 with a higher score indicating better quality of life'}, {'measure': 'Psychosocial stress', 'timeFrame': '6 weeks', 'description': 'assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary prevention'], 'conditions': ['Metabolic Disturbance', 'Sedentary Behavior']}, 'descriptionModule': {'briefSummary': 'Ms. FIT pilot is a pilot study of a 3-arm RCT with equal recruitment and stratification of pre and postmenopausal women with risk factors for chronic disease to: 1) Canadian guidelines-based physical activity alone; 2) Canadian guidelines-based physical activity and healthy eating; or 3) stretching attention control. The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of the interventions. The objectives are to: 1) pilot test the intervention delivery protocol in a real-world application (management and technical capabilities of the research group); 2) evaluate adherence and participant acceptability of a combined in-person and virtual intervention delivery in both pre and post-menopausal women; 3) identify the preliminary efficacy of the interventions on select cardiometabolic risk markers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* females\n* pre- or postmenopausal\n* aged 30+ years\n* moderate or high Canadian Diabetes Risk Score score\n\nExclusion Criteria:\n\n* diagnoses of cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), or respiratory disease (i.e., COPD)\n* major signs or symptoms (regardless of known diagnosis) of cardiovascular diseases, diabetes, or renal disease\n* pregnant or lactating\n* mobility limitations to exercise\n* smoking cigarettes within the past 3 months\n* using transdermal hormones, taking exogenous hormones or receiving exogenous hormones from other means (e.g. intrauterine device)\n* self-report of \\>30 min/week of MVPA\n* following a specific dietary practice (e.g., vegan, ketogenic) in last 3 months\n* presenting with any of the American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing\n* requiring and do not receive medical clearance for maximal exercise\n* cannot read and understand the consent form or communicate in English\n* individuals who are students in classes of the professors who are involved in the study or students with whom the professors have a supervisory relationship"}, 'identificationModule': {'nctId': 'NCT05758857', 'acronym': 'Ms FIT', 'briefTitle': 'Multiple Risk Factor Intervention Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Multiple Risk Factor Intervention Trial: A Pilot Study', 'orgStudyIdInfo': {'id': '43521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guidelines-based physical activity', 'description': '150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening', 'interventionNames': ['Behavioral: Experimental: Guidelines-based physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Guidelines-based physical activity and healthy eating', 'description': "150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide", 'interventionNames': ['Behavioral: Experimental: Guidelines-based physical activity', 'Behavioral: Experimental: Guidelines-based healthy eating']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stretching exercise', 'description': 'Whole-body stretching', 'interventionNames': ['Behavioral: Stretching exercise']}], 'interventions': [{'name': 'Experimental: Guidelines-based physical activity', 'type': 'BEHAVIORAL', 'description': 'Through a combination of exercise trainer-led in-person and virtual sessions, as well as counselling for independent aerobic exercise, participants will be guided to achieve 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.', 'armGroupLabels': ['Guidelines-based physical activity', 'Guidelines-based physical activity and healthy eating']}, {'name': 'Experimental: Guidelines-based healthy eating', 'type': 'BEHAVIORAL', 'description': "One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.", 'armGroupLabels': ['Guidelines-based physical activity and healthy eating']}, {'name': 'Stretching exercise', 'type': 'BEHAVIORAL', 'description': 'Twice weekly virtual instructor-led whole-body stretching class.', 'armGroupLabels': ['Stretching exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 2C9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Goldring Centre for High Performance Sport', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': "Women's College Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amy Kirkham', 'investigatorAffiliation': 'University of Toronto'}}}}