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Multiple Risk Factor Intervention Trial (Ms. FIT)

RecruitingNAAges 30 Years - anyFemaleUniversity of Toronto
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In plain words

What the trial is, and whether it could suit you

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,

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Biologically female * Aged 30+ * Pre- or postmenopausal: Premenopause: having regular menstrual cycles (21-35 days long without a persistent difference of โ‰ฅ7 days between cycles). Post-menopause: โ‰ฅ12 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 โ‰ฅ 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: โ‰ฅ90cm; BMI 30-34.9: WC: โ‰ฅ105cm; BMI 35-35.9: WC: โ‰ฅ115cm) 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
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What it tests

  • Behavioural Experimental: guidelines-based physical activity
  • Behavioural Experimental: guidelines-based physical activity and healthy eating
  • Behavioural: Stretching exercise
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Where

1 site
University of Toronto
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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