Multiple Risk Factor Intervention Trial (Ms. FIT)

NCT06345937 | Recruiting

• 1 other identifier: REB #44724
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Disturbance; Sedentary Behavior

Keywords

Primary Prevention

Outcome Measures

Primary Outcomes (1)

• Insulin resistance

  As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).

  6 months

Secondary Outcomes (3)

• Hepatic insulin resistance

  6 months

• Metabolic syndrome severity

  6 months

• Framingham 10-year risk (%)

  6 months

Other Outcomes (46)

• Cardiorespiratory fitness

  6 months

• Heart Rate Recovery

  6 months

• Exercise stroke volume & cardiac output

  6 months

Study Arms (3)

Guidelines-based physical activity

EXPERIMENTAL

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening

Behavioral: Behavioural Experimental: guidelines-based physical activity

Guidelines-based physical activity and healthy eating

EXPERIMENTAL

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide

Behavioral: Behavioural Experimental: guidelines-based physical activity and healthy eating

Stretching exercise

PLACEBO COMPARATOR

Whole-body stretching

Behavioral: Behavioural: Stretching exercise

Interventions

Behavioural Experimental: guidelines-based physical activity BEHAVIORAL

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.

Guidelines-based physical activity

Behavioural Experimental: guidelines-based physical activity and healthy eating BEHAVIORAL

Behavioural Experimental: guidelines-based physical activity: 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. Behavioural Experimental: guidelines-based healthy eating: One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.

Guidelines-based physical activity and healthy eating

Behavioural: Stretching exercise BEHAVIORAL

Twice weekly virtual instructor-led whole-body stretching.

Stretching exercise

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biologically female
• Aged 30+
• Pre- or postmenopausal: Premenopause: having regular menstrual cycles (21-35 days long without a persistent difference of ≥7 days between cycles). Post-menopause: ≥12 months of amenorrhea or history of double oophorectomy and do not have irregular or occasional menstrual cycle in last 12 months.
• Participants will have multiple risk factors for cardiometabolic disease, namely: being sedentary (\<30 min of moderate-vigorous physical activity/week), having a BMI ≥ 25 kg/m\^2, and one or more of the following: a waist circumference indicative of abdominal obesity, specific to BMI (e.g., BMI 25-29.9: WC: ≥90cm; BMI 30-34.9: WC: ≥105cm; BMI 35-35.9: WC: ≥115cm) OR a diagnosis of either hypertension, pre-diabetes (heightened blood sugar levels), or dyslipidemia (heightened blood lipid levels)
• Able to commit to come to the University once per week for 24 weeks.

You may not qualify if:

• Perimenopausal or those whom the investigators cannot discern pre- vs perimenopausal status
• Diagnosed cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), or respiratory disease (e.g., Chronic obstructive pulmonary disease (COPD) or severe or uncontrolled asthma).
• Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.)
• American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and/or endocarditis), uncontrolled cardiac arrythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \>200mmHg/100mmHg, a cancer diagnosis other than skin cancer)
• Unable to provide informed consent or communicate in English
• Pregnant or breast-feeding currently or in the past 3 months
• Mobility limitations to aerobic exercise (i.e., wheelchair, walker use, limp impeding walking)
• Smoking cigarettes or marijuana within the past 3 months
• Taking exogenous hormones in any format currently or in the past 3 months
• Contraindications to research MRI (e.g., pacemaker, magnetic implants)
• BMI exceeding 40 kg/m2
• Extreme claustrophobia
• Self-report \>30 min/week of moderate-to-vigorous intensity aerobic physical activity
• Following a diet that largely restricts entire food groups or time of eating (e.g., vegan, ketogenic, carnivore, one meal a day) in last 3 months
• Students in classes or labs of the professors who are involved in the study

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 2C9, Canada

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Amy A. Kirkham, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy A. Kirkham, PhD

CONTACT

416-946-4069; amy.kirkham@utoronto.ca

Jenna B. Gillen, PhD

CONTACT

416-978-3244; jenna.gillen@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 3-arm parallel-group randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: May 3, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)