Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Women's College Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guidelines-based physical activity | Experimental | 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening |
|
| Guidelines-based physical activity and healthy eating | Experimental | 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide |
|
| Stretching exercise | Placebo Comparator | Whole-body stretching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Guidelines-based physical activity | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity intervention feasibility | Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch | 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 | end of week 6 |
| Intervention acceptability | Assessed via researcher-developed questionnaire | end of week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic insulin resistance | As assessed by the Matsuda Index calculated from an oral glucose tolerance test | 6 weeks |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | calculated as: (fasting insulin*fasting glucose)/22.5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Psychosocial stress |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goldring Centre for High Performance Sport | Toronto | Ontario | M5S 2C9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
3-arm parallel-group randomized controlled trial
Not provided
Not provided
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.
|
| Experimental: Guidelines-based healthy eating | Behavioral | One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide. |
|
| Stretching exercise | Behavioral | Twice weekly virtual instructor-led whole-body stretching class. |
|
| 6 weeks |
| Framingham 10-year risk (%) | Calculated using standardized scoring system | 6 weeks |
| Lipid profile | analyzed from blood | 6 weeks |
| C-Reactive Protein | analyzed from blood | 6 weeks |
| Blood pressure | Measured after several minutes of supine rest | 6 weeks |
| Aortic stiffness (central to femoral) | Measured via Shygmacor device | 6 weeks |
| Brachial artery endothelial function | Measured via flow-mediated dilatation test | 6 weeks |
| Cardiorespiratory fitness | Measured as peak volume of oxygen consumption via indirect calorimetry | 6 weeks |
| Whole-body fat and fat free mass | Measured by BodPod | 6 weeks |
| Body circumferences | Waist, hip and neck circumferences measured by inelastic tape | 6 weeks |
| Depressive symptoms | measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression | 6 weeks |
| Dietary intake | Assessed via ASA-24 3-day food records | 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. | 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 | 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 | 6 weeks |
assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress
| 6 months |
| Intervention acceptability | Assessed via researcher-developed questionnaire | 6 months |
| 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. | 6 months |
| Dietary intake | Assessed via ASA-24 3-day food records | 6 months |
| Depressive symptoms | measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression | 6 months |
| Body circumferences | Waist, hip and neck circumferences measured by inelastic tape | 6 months |
| Whole-body fat and fat free mass | Measured by BodPod | 6 months |
| Cardiorespiratory fitness | Measured as peak volume of oxygen consumption via indirect calorimetry | 6 months |
| Blood pressure | Measured after several minutes of supine rest | 6 months |
| Physical activity intervention feasibility | Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch | 6 months |
| Diet quality intervention feasibility | Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record | 6 months |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |