Intervention for reducing cardiometabolic risk in women through exercise and diet
Official title: Multiple Risk Factor Intervention Trial (Ms. FIT)
Run by University of Toronto · NCT06345937 · Data updated 2026-11-12
This study is testing whether exercise alone, or exercise combined with diet advice, can help pre and postmenopausal women lower their risk of heart and metabolic issues.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | Women only |
| Enrollment | 180 (estimated) |
| Sponsor | University of Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | May 3, 2024 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2028 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT06345937 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are biologically female individuals aged 30 and older who are pre or postmenopausal and have a high CANRISK score.
✕Probably not a fit
Patients who are perimenopausal or have diagnosed cardiovascular diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on evaluating the effectiveness of exercise and dietary interventions specifically for pre and postmenopausal women to reduce cardiometabolic risks. It employs a 3-arm randomized controlled trial design, comparing guidelines-based physical activity alone, a combination of physical activity and dietary counseling, and a stretching control group over a 6-month period. The study aims to understand how these interventions impact various factors related to physical inactivity and cardiometabolic disease, particularly in relation to menopausal status.
Why it matters
Potential benefit: If successful, this study could provide tailored strategies for women to significantly reduce their risk of cardiometabolic diseases.
How similar studies have gone: Other studies have shown success with similar interventions focusing on exercise and diet for cardiometabolic risk reduction, particularly in women.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Toronto
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Amy A. Kirkham, PhD — University of Toronto
- Study coordinator: Amy A. Kirkham, PhD
- Email: amy.kirkham@utoronto.ca
- Phone: 416-946-4069
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Exercise and diet to lower heart and metabolic risk in breast cancer survivors
This project will test whether a 6-month program of Health Canada–based exercise, with or without a healthy-eating counseling program, helps reduce cardiometabolic risk and improve body composition in postmenopausal women who survived early-stage breast cancer and have overweight.
-
Acute Endocrine Responses to Aerobic vs. Anaerobic Exercise in Sedentary Young Women
This study tests how thyroid hormones and cortisol change after aerobic versus anaerobic exercise in sedentary women aged 18-25.
-
See if short bursts of activity every day improve fitness and health in inactive young adults
This study tests whether short, frequent bouts of exercise throughout the day can boost activity levels, fitness, and health in adults who aren’t currently active.
-
Family Good Health Traditions for Life program
This program will try a community-tailored, family-based version of the Diabetes Prevention Program to help Black parents with prediabetes and their children lower weight and reduce diabetes risk.
-
Mat Pilates to improve body awareness and activity in sedentary young women
This program will try mat Pilates for 8 weeks to see if it helps sedentary women aged 18–29 increase body awareness and physical activity.
-
Sit Less, Move More program to increase physical activity during pregnancy
This program will try a Fitbit-based Sit Less, Move More plan to help pregnant women under 12 weeks gestation who do less than 150 minutes of activity per week sit less and move more.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.