Multiple Risk Factor Intervention Trial (Ms. FIT)

NCT ID: NCT06345937

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-03
• Study Completion Date: 2028-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Guidelines-based physical activity

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

Group Type: EXPERIMENTAL

Behavioural Experimental: guidelines-based physical activity

Intervention Type: 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 and healthy eating

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

Group Type: EXPERIMENTAL

Behavioural Experimental: guidelines-based physical activity and healthy eating

Intervention Type: 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.

Stretching exercise

Whole-body stretching

Group Type: PLACEBO_COMPARATOR

Behavioural: Stretching exercise

Intervention Type: BEHAVIORAL

Twice weekly virtual instructor-led whole-body stretching.

Interventions

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.

Intervention Type: BEHAVIORAL

Behavioural Experimental: guidelines-based physical activity and healthy eating

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.

Intervention Type: BEHAVIORAL

Behavioural: Stretching exercise

Twice weekly virtual instructor-led whole-body stretching.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Experienced significant weight loss (i.e., >5 kg) in past 3 months
• Currently taking weight loss medications
• Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder
• Plans to be away/unavailable for a substantial period of the intervention overall (i.e., >4 weeks throughout the 6 months or >2 weeks within the first 12 weeks of the intervention).
• Allergies to local anesthetics

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Amy Kirkham

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy A. Kirkham, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

University of Toronto

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Amy A. Kirkham, PhD

Role: CONTACT

amy.kirkham@utoronto.ca

416-946-4069

Jenna B. Gillen, PhD

Role: CONTACT

jenna.gillen@utoronto.ca

416-978-3244

Facility Contacts

Amy A. Kirkham, PhD

Role: primary

amy.kirkham@utoronto.ca

416-946-4069

Jenna B. Gillen, PhD

Role: backup

jenna.gillen@utoronto.ca

416-978-3244

Other Identifiers

REB #44724

Identifier Type: -

Identifier Source: org_study_id