Metabolic Disturbance, Sedentary Behavior
Conditions
Keywords
primary prevention
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.
Interventions
BEHAVIORALExperimental: Guidelines-based physical activity
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.
BEHAVIORALExperimental: Guidelines-based healthy eating
One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.
BEHAVIORALStretching exercise
Twice weekly virtual instructor-led whole-body stretching class.
Sponsors
Women's College Hospital
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment.
Intervention model description
3-arm parallel-group randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* females * pre- or postmenopausal * aged 30+ years * moderate or high Canadian Diabetes Risk Score score
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Physical activity intervention feasibility | end of week 6 | Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch |
| Intervention acceptability | end of week 6 | Assessed via researcher-developed questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Framingham 10-year risk (%) | 6 weeks | Calculated using standardized scoring system |
| Aortic stiffness (central to femoral) | 6 weeks | Measured via Shygmacor device |
| Lipid profile | 6 weeks | analyzed from blood |
| C-Reactive Protein | 6 weeks | analyzed from blood |
| Systemic insulin resistance | 6 weeks | As assessed by the Matsuda Index calculated from an oral glucose tolerance test |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | 6 weeks | calculated as: (fasting insulin\*fasting glucose)/22.5 |
| Cardiorespiratory fitness | 6 weeks | Measured as peak volume of oxygen consumption via indirect calorimetry |
| 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 |
| Depressive symptoms | 6 weeks | measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression |
| Dietary intake | 6 weeks | Assessed via ASA-24 3-day food records |
| 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. |
| 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 |
| 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 |
| Brachial artery endothelial function | 6 weeks | Measured via flow-mediated dilatation test |
| Blood pressure | 6 weeks | Measured after several minutes of supine rest |
Other
| Measure | Time frame | Description |
|---|---|---|
| Menopausal symptom presence and severity | 6 months | 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. |
| Dietary intake | 6 months | Assessed via ASA-24 3-day food records |
| Depressive symptoms | 6 months | measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression |
| Body circumferences | 6 months | Waist, hip and neck circumferences measured by inelastic tape |
| Whole-body fat and fat free mass | 6 months | Measured by BodPod |
| Cardiorespiratory fitness | 6 months | Measured as peak volume of oxygen consumption via indirect calorimetry |
| Blood pressure | 6 months | Measured after several minutes of supine rest |
| Physical activity intervention feasibility | 6 months | Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch |
| Diet quality intervention feasibility | 6 months | Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record |
| Psychosocial stress | 6 months | 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 months | 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 |
| Intervention acceptability | 6 months | Assessed via researcher-developed questionnaire |
Countries
Canada
Outcome results
None listed