Multiple Risk Factor Intervention Trial (Ms. FIT) (MsFIT)

University of Toronto

Status: Enrolling

Conditions: Metabolic Disturbance; Sedentary Behavior

Treatments: Behavioral: Behavioural Experimental: guidelines-based physical activity; Behavioral: Behavioural: Stretching exercise; Behavioral: Behavioural Experimental: guidelines-based physical activity and healthy eating

Study type: Interventional

Funder types: Other

Identifiers

NCT06345937

REB #44724

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups, including a placebo group

Guidelines-based physical activity

Experimental group

Description:

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

Treatment:

Behavioral: Behavioural Experimental: guidelines-based physical activity

Guidelines-based physical activity and healthy eating

Experimental group

Description:

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

Treatment:

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

Stretching exercise

Placebo Comparator group

Description:

Whole-body stretching

Treatment:

Behavioral: Behavioural: Stretching exercise