Multiple Risk Factor Intervention Trial (Ms. FIT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30+
SponsorUniversity of Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m², 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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioural Experimental: guidelines-based physical activity
BehavioralThrough 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 physical activity and healthy eating
BehavioralBehavioural 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.
Behavioural: Stretching exercise
BehavioralTwice weekly virtual instructor-led whole-body stretching.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Guidelines-based physical activityExperimental treatment 1 intervention
Group B: Guidelines-based physical activity and healthy eatingExperimental treatment 1 intervention
Group C: Stretching exercisePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insulin resistance
As assessed by the Matsuda Index calculated from an oral glucose tolerance test (OGTT).
Time frame
6 monthsSecondary outcomes
1
Hepatic insulin resistance
Indirectly measured via HOMA-IR using fasting glucose and insulin levels
Time frame
6 months2
Metabolic syndrome severity
Calculated as a z-score to allow for tracking change in the interventions
Time frame
6 months3
Framingham 10-year risk (%)
Calculated using a widely-used standardized scoring system
Time frame
6 monthsOther outcomes
1
Cardiorespiratory fitness
Measured as peak volume of oxygen consumption via indirect calorimetry during a cardiopulmonary exercise test on a treadmill.
Time frame
6 months2
Heart Rate Recovery
Measured as the difference between peak heart rate during the cardiorespiratory fitness test and heart rate 2-minutes after stopping the exercise test.
Time frame
6 months3
Exercise stroke volume & cardiac output
Measured during submaximal and maximal periods of a cycling exercise test, using echocardiography.
Time frame
6 months4
Left ventricular ejection fraction
Measured during rest, submaximal and maximal periods of cycling exercise test, using echocardiography
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov