Multiple Risk Factor Intervention Trial (Ms. FIT)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
University of Toronto
RECRUITING
Toronto
Contact Information
Primary
Amy A. Kirkham, PhD
amy.kirkham@utoronto.ca
416-946-4069
Backup
Jenna B. Gillen, PhD
jenna.gillen@utoronto.ca
416-978-3244
Time Frame
Start Date: 2024-05-03
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 180
Treatments
Experimental: Guidelines-based physical activity
150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening
Experimental: Guidelines-based physical activity and healthy eating
150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide
Placebo_comparator: Stretching exercise
Whole-body stretching
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: University of Toronto

This content was sourced from clinicaltrials.gov