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New treatment option for Metabolic Disturbance
Official title Multiple Risk Factor Intervention Trial (Ms. FIT)
ClinicalTrials.gov ID: NCT06345937
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older, women only
You may be able to join if
- 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)...
- Participants will have multiple risk factors for cardiometabolic disease, namely: being sedentary (\<30 min of moderate-vigorous physical...
- Able to commit to come to the University once per week for 24 weeks.
You likely can't join if
- 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...
- Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for...
- American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or...
- Unable to provide informed consent or communicate in English
- Pregnant or breast-feeding currently or in the past 3 months
See the full eligibility 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...
- 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...
- Able to commit to come to the University once per week for 24 weeks.
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.