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Completed

NCT Number: NCT05758857

Multiple Risk Factor Intervention Trial

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.

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Key information

Conditions

Metabolic Disturbance Behavior Sedentary Behavior

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Physical activity intervention feasibility

    Time frame: end of week 6

    Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch

  2. Diet quality intervention feasibility

    Time frame: end of week 6

    Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record

  3. Intervention acceptability

    Time frame: end of week 6

    Assessed via researcher-developed questionnaire

Secondary outcomes

  1. Systemic insulin resistance

    Time frame: 6 weeks

    As assessed by the Matsuda Index calculated from an oral glucose tolerance test

  2. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: 6 weeks

    calculated as: (fasting insulin*fasting glucose)/22.5

  3. Framingham 10-year risk (%)

    Time frame: 6 weeks

    Calculated using standardized scoring system

  4. Lipid profile

    Time frame: 6 weeks

    analyzed from blood

  5. C-Reactive Protein

    Time frame: 6 weeks

    analyzed from blood

  6. Blood pressure

    Time frame: 6 weeks

    Measured after several minutes of supine rest

  7. Aortic stiffness (central to femoral)

    Time frame: 6 weeks

    Measured via Shygmacor device

  8. Brachial artery endothelial function

    Time frame: 6 weeks

    Measured via flow-mediated dilatation test

  9. Cardiorespiratory fitness

    Time frame: 6 weeks

    Measured as peak volume of oxygen consumption via indirect calorimetry

  10. Whole-body fat and fat free mass

    Time frame: 6 weeks

    Measured by BodPod

  11. Body circumferences

    Time frame: 6 weeks

    Waist, hip and neck circumferences measured by inelastic tape

  12. Depressive symptoms

    Time frame: 6 weeks

    measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression

  13. Dietary intake

    Time frame: 6 weeks

    Assessed via ASA-24 3-day food records

  14. Menopausal symptom presence and severity

    Time frame: 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.

  15. Health-related quality of life

    Time frame: 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

  16. Psychosocial stress

    Time frame: 6 weeks

    assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress

Other outcomes

  1. Health-related quality of life

    Time frame: 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

  2. Psychosocial stress

    Time frame: 6 months

    assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress

  3. Intervention acceptability

    Time frame: 6 months

    Assessed via researcher-developed questionnaire

  4. Menopausal symptom presence and severity

    Time frame: 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.

  5. Dietary intake

    Time frame: 6 months

    Assessed via ASA-24 3-day food records

  6. Depressive symptoms

    Time frame: 6 months

    measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression

  7. Body circumferences

    Time frame: 6 months

    Waist, hip and neck circumferences measured by inelastic tape

  8. Whole-body fat and fat free mass

    Time frame: 6 months

    Measured by BodPod

  9. Cardiorespiratory fitness

    Time frame: 6 months

    Measured as peak volume of oxygen consumption via indirect calorimetry

  10. Blood pressure

    Time frame: 6 months

    Measured after several minutes of supine rest

  11. Physical activity intervention feasibility

    Time frame: 6 months

    Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch

  12. Diet quality intervention feasibility

    Time frame: 6 months

    Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Women's College Hospital

Registry information

Official study title

Multiple Risk Factor Intervention Trial: A Pilot Study

Acronym: Ms FIT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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