Actively Recruiting

Phase Not Applicable
Age: 30Years +
FEMALE
NCT06345937

Multiple Risk Factor Intervention Trial (Ms. FIT)

Led by University of Toronto · Updated on 2025-09-17

180

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

U

University of Toronto

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause.

CONDITIONS

Official Title

Multiple Risk Factor Intervention Trial (Ms. FIT)

Who Can Participate

Age: 30Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biologically female
  • Aged 30 years or older
  • Premenopausal with regular menstrual cycles (21-35 days without a persistent difference of 657 days between cycles) or postmenopausal with 12 months or more of amenorrhea or history of double oophorectomy without irregular or occasional menstrual cycles in the last 12 months
  • Sedentary, defined as less than 30 minutes of moderate-to-vigorous physical activity per week
  • Body mass index (BMI) of 25 kg/m2 or higher
  • One or more of the following: waist circumference indicating abdominal obesity specific to BMI category, diagnosis of hypertension, pre-diabetes, or dyslipidemia
  • Able to commit to attending the University once per week for 24 weeks
Not Eligible

You will not qualify if you...

  • Perimenopausal or uncertain menopausal status
  • Diagnosed cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except non-melanoma skin cancer), or respiratory diseases such as COPD or severe/uncontrolled asthma
  • Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (e.g., chest pain, shortness of breath at rest or with mild exertion, dizziness, loss of balance, ankle swelling, palpitations, unusual fatigue)
  • Absolute or relative contraindications for maximal exercise testing as defined by the American Heart Association (e.g., myocardial infarction, heart failure, uncontrolled arrhythmia, stroke, high blood pressure over 200/100 mmHg)
  • Unable to provide informed consent or communicate in English
  • Currently pregnant or breastfeeding or within the past 3 months
  • Mobility limitations affecting aerobic exercise (wheelchair, walker use, limping)
  • Smoking cigarettes or marijuana within the past 3 months
  • Use of exogenous hormones currently or in the past 3 months
  • Contraindications to MRI such as pacemakers or magnetic implants
  • Body mass index (BMI) over 40 kg/m2
  • Extreme claustrophobia
  • Engaging in more than 30 minutes per week of moderate-to-vigorous aerobic physical activity
  • Following a diet that restricts entire food groups or limits eating times (e.g., vegan, ketogenic) in the past 3 months
  • Students in classes or labs of the study professors
  • Significant weight loss over 5 kg in the past 3 months
  • Currently taking weight loss medications
  • Diagnosed or suspected eating disorder
  • Plans to be unavailable for more than 4 weeks during the 6-month intervention or more than 2 weeks in the first 12 weeks
  • Allergies to local anesthetics

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Toronto

Toronto, Ontario, Canada, M5S 2C9

Actively Recruiting

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Research Team

A

Amy A. Kirkham, PhD

CONTACT

J

Jenna B. Gillen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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