protocolSection identificationModule nctId: NCT06345937, orgStudyIdInfo id: REB #44724, briefTitle: Multiple Risk Factor Intervention Trial (Ms. FIT), acronym: MsFIT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Toronto, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:* How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?* What is the effect modification of adding a diet quality intervention to exercise?* What is the effect modification by menopausal status?The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause., conditionsModule conditions: Metabolic Disturbance, conditions: Sedentary Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 3-arm parallel-group randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, 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., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Behavioural Experimental: guidelines-based physical activity, interventions name: Behavioural Experimental: guidelines-based physical activity and healthy eating, interventions name: Behavioural: Stretching exercise, outcomesModule primaryOutcomes measure: Insulin resistance, secondaryOutcomes measure: Hepatic insulin resistance, secondaryOutcomes measure: Metabolic syndrome severity, secondaryOutcomes measure: Framingham 10-year risk (%), otherOutcomes measure: Cardiorespiratory fitness, otherOutcomes measure: Heart Rate Recovery, otherOutcomes measure: Exercise stroke volume & cardiac output, otherOutcomes measure: Left ventricular ejection fraction, otherOutcomes measure: Left ventricular mass, otherOutcomes measure: Arteriovenous Oxygen Difference (avO2diff), otherOutcomes measure: Endothelial Function, otherOutcomes measure: Carotid Intima Media Thickness, otherOutcomes measure: Central & Peripheral Arterial stiffness, otherOutcomes measure: Blood Pressure, otherOutcomes measure: Resting Heart Rate & Heart Rate Variability, otherOutcomes measure: Thigh Myosteatosis, otherOutcomes measure: Knee flexion and extension (strength and endurance), otherOutcomes measure: Thigh Muscle Volume, otherOutcomes measure: Biochemical markers of skeletal muscle protein content, otherOutcomes measure: Biochemical markers of skeletal muscle structure, otherOutcomes measure: Biochemical markers of skeletal muscle enzyme activity, otherOutcomes measure: Whole-body fat and fat-free mass, otherOutcomes measure: Visceral adipose tissue, otherOutcomes measure: Liver fat fraction, otherOutcomes measure: Body circumferences, otherOutcomes measure: Concentration of inflammation biomarkers in blood, otherOutcomes measure: Lipid panel: high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total Cholesterol, Triglycerides, otherOutcomes measure: Hemoglobin A1c, otherOutcomes measure: Dietary intake, otherOutcomes measure: Liver enzymes: alanine transaminase (ALT), aspartate aminotransferase (AST), and albumin, otherOutcomes measure: Liver fibrosis, otherOutcomes measure: Aerobic physical activity adherence, otherOutcomes measure: Resistance exercise adherence, otherOutcomes measure: Diet quality, otherOutcomes measure: Health-related quality of life, otherOutcomes measure: Menopausal symptom presence and severity, otherOutcomes measure: Psychosocial stress, otherOutcomes measure: Depression & Anxiety, otherOutcomes measure: Barriers and self-efficacy for physical activity, otherOutcomes measure: Physical activity motivation, otherOutcomes measure: Sleep quality - subjective, otherOutcomes measure: Sleep quantity and quality - device measured, otherOutcomes measure: Self-reported physical activity, otherOutcomes measure: Serum Estradiol, otherOutcomes measure: Salivary Estradiol, otherOutcomes measure: Hemoglobin, otherOutcomes measure: Free fatty acids, otherOutcomes measure: Body weight, otherOutcomes measure: Body mass index (BMI), otherOutcomes measure: Energy Balance, eligibilityModule sex: FEMALE, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Toronto, status: RECRUITING, city: Toronto, state: Ontario, zip: M5S 2C9, country: Canada, contacts name: Amy A. Kirkham, PhD, role: CONTACT, phone: 416-946-4069, email: amy.kirkham@utoronto.ca, contacts name: Jenna B. Gillen, PhD, role: CONTACT, phone: 416-978-3244, email: jenna.gillen@utoronto.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False