Clinical trial Recruiting at 1 site Interventional Ages 30 and up Women only

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 typeInterventional
Ages30 Years and up
SexWomen only
Enrollment180 (estimated)
SponsorUniversity of Toronto
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedMay 3, 2024
Main results expectedAugust 1, 2027
Study endsAugust 1, 2028
Registry record updatedSeptember 17, 2025
Trial IDNCT06345937 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.