Multiple Risk Factor Intervention Trial
- Conditions
- Sedentary BehaviorMetabolic Disturbance
- Interventions
- Behavioral: Stretching exercise
- Registration Number
- NCT05758857
- Lead Sponsor
- University of Toronto
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- females
- pre- or postmenopausal
- aged 30+ years
- moderate or high Canadian Diabetes Risk Score score
- diagnoses of cardiovascular diseases, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), or respiratory disease (i.e., COPD)
- major signs or symptoms (regardless of known diagnosis) of cardiovascular diseases, diabetes, or renal disease
- pregnant or lactating
- mobility limitations to exercise
- smoking cigarettes within the past 3 months
- using transdermal hormones, taking exogenous hormones or receiving exogenous hormones from other means (e.g. intrauterine device)
- self-report of >30 min/week of MVPA
- following a specific dietary practice (e.g., vegan, ketogenic) in last 3 months
- presenting with any of the American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing
- requiring and do not receive medical clearance for maximal exercise
- cannot read and understand the consent form or communicate in English
- individuals who are students in classes of the professors who are involved in the study or students with whom the professors have a supervisory relationship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stretching exercise Stretching exercise Whole-body stretching
- Primary Outcome Measures
Name Time Method Physical activity intervention feasibility end of week 6 Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch
Diet quality intervention feasibility end of week 6 Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record
Intervention acceptability end of week 6 Assessed via researcher-developed questionnaire
- Secondary Outcome Measures
Name Time Method C-Reactive Protein 6 weeks analyzed from blood
Whole-body fat and fat free mass 6 weeks Measured by BodPod
Body circumferences 6 weeks Waist, hip and neck circumferences measured by inelastic tape
Menopausal symptom presence and severity 6 weeks 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.
Systemic insulin resistance 6 weeks As assessed by the Matsuda Index calculated from an oral glucose tolerance test
Aortic stiffness (central to femoral) 6 weeks Measured via Shygmacor device
Cardiorespiratory fitness 6 weeks Measured as peak volume of oxygen consumption via indirect calorimetry
Dietary intake 6 weeks Assessed via ASA-24 3-day food records
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) 6 weeks calculated as: (fasting insulin\*fasting glucose)/22.5
Framingham 10-year risk (%) 6 weeks Calculated using standardized scoring system
Blood pressure 6 weeks Measured after several minutes of supine rest
Brachial artery endothelial function 6 weeks Measured via flow-mediated dilatation test
Depressive symptoms 6 weeks measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression
Psychosocial stress 6 weeks assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress
Health-related quality of life 6 weeks 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
Lipid profile 6 weeks analyzed from blood
Trial Locations
- Locations (1)
Goldring Centre for High Performance Sport
🇨🇦Toronto, Ontario, Canada