Ms. FIT pilot is a pilot study of a 3-arm RCT with equal recruitment and stratification of pre and postmenopausal women with risk factors for chronic disease to: 1) Canadian guidelines-based physical activity alone; 2) Canadian guidelines-based physical activity and healthy eating; or 3) stretching attention control. The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of the interventions. The objectives are to: 1) pilot test the intervention delivery protocol in a real-world application (management and technical capabilities of the research group); 2) evaluate adherence and participant acceptability of a combined in-person and virtual intervention delivery in both pre and post-menopausal women; 3) identify the preliminary efficacy of the interventions on select cardiometabolic risk markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Through a combination of exercise trainer-led in-person and virtual sessions, as well as counselling for independent aerobic exercise, participants will be guided to achieve 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.
One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.
Twice weekly virtual instructor-led whole-body stretching class.
Goldring Centre for High Performance Sport
Toronto, Ontario, Canada
Physical activity intervention feasibility
Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch
Time frame: end of week 6
Diet quality intervention feasibility
Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record
Time frame: end of week 6
Intervention acceptability
Assessed via researcher-developed questionnaire
Time frame: end of week 6
Systemic insulin resistance
As assessed by the Matsuda Index calculated from an oral glucose tolerance test
Time frame: 6 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
calculated as: (fasting insulin\*fasting glucose)/22.5
Time frame: 6 weeks
Framingham 10-year risk (%)
Calculated using standardized scoring system
Time frame: 6 weeks
Lipid profile
analyzed from blood
Time frame: 6 weeks
C-Reactive Protein
analyzed from blood
Time frame: 6 weeks
Blood pressure
Measured after several minutes of supine rest
Time frame: 6 weeks
Aortic stiffness (central to femoral)
Measured via Shygmacor device
Time frame: 6 weeks
Brachial artery endothelial function
Measured via flow-mediated dilatation test
Time frame: 6 weeks
Cardiorespiratory fitness
Measured as peak volume of oxygen consumption via indirect calorimetry
Time frame: 6 weeks
Whole-body fat and fat free mass
Measured by BodPod
Time frame: 6 weeks
Body circumferences
Waist, hip and neck circumferences measured by inelastic tape
Time frame: 6 weeks
Depressive symptoms
measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression
Time frame: 6 weeks
Dietary intake
Assessed via ASA-24 3-day food records
Time frame: 6 weeks
Menopausal symptom presence and severity
assessed by The Menopause-specific Quality of Life (MENQOL) questionnaire. Each of four domains is constrained between 1 to 8 where a higher score indicates more symptoms.
Time frame: 6 weeks
Health-related quality of life
Assessed by RAND-36, where an independent score is provided for 8 scales ranging from 0 to 100 with a higher score indicating better quality of life
Time frame: 6 weeks
Psychosocial stress
assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress
Time frame: 6 weeks
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