Multiple Risk Factor Intervention Trial (Ms. FIT)

Launched by UNIVERSITY OF TORONTO · Mar 28, 2024

Keywords

ClinConnect Summary

The Multiple Risk Factor Intervention Trial (Ms. FIT) is a research study designed to understand how exercise and diet can help reduce the risk of heart and metabolic problems in women, particularly those who are premenopausal or postmenopausal. The study will involve three groups of women who will participate for six months: one group will do exercise based on Health Canada’s guidelines, another group will do the same exercise but will also receive advice on improving their diet, and the third group will do stretching exercises. The researchers aim to find out how effective exercise is in improving health and whether adding dietary changes enhances those benefits, especially for women in different stages of menopause.

To join the study, women must be at least 30 years old, biologically female, and either premenopausal or postmenopausal with a higher risk of type 2 diabetes, as determined by a specific online tool. Participants should be able to visit the study location once a week for six months. Those with certain health conditions, such as heart disease or diabetes, or who are currently pregnant or have recently lost a lot of weight, unfortunately, cannot participate. Throughout the trial, participants can expect guidance in their exercise routines and dietary practices while contributing to important research that may help improve health outcomes for women in the future.

Gender

FEMALE

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.
• • High CANRISK score (score of ≥33): The online CANRISK tool (www.healthycanadians.gc.ca/en/canrisk) assigns scores to risk factors for type 2 diabetes (that overlap with cardiovascular disease/cancer), including age, body mass index, moderate-vigorous physical activity (MVPA), fruit/vegetable intake, hypertension, pregnancy complications, ethnicity and education, and is validated for Canada's multiethnic population.
• • 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