Intervention for reducing cardiometabolic risk in women through exercise and diet

Multiple Risk Factor Intervention Trial (Ms. FIT)

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

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 30 Years and up
• Sex: Female
• Sponsor: University of Toronto (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06345937 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are biologically female individuals aged 30 and older who are pre or postmenopausal and have a high CANRISK score.

Not a fit: Patients who are perimenopausal or have diagnosed cardiovascular diseases may not benefit from this study.

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 performed: Other studies have shown success with similar interventions focusing on exercise and diet for cardiometabolic risk reduction, particularly in women.

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.
* 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 this trial is running

Toronto, Ontario

• University of Toronto — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Amy A. Kirkham, PhD — University of Toronto
• Study coordinator: Amy A. Kirkham, PhD

Conditions: Metabolic Disturbance, Sedentary Behavior, Primary Prevention