Multiple Risk Factor Intervention Trial (Ms FIT)

Multiple Risk Factor Intervention Trial: A Pilot Study

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 Overview

• Status: Completed
• Conditions: Sedentary Behavior; Metabolic Disturbance
• Intervention / Treatment: Behavioral: Experimental: Guidelines-based physical activity; Behavioral: Experimental: Guidelines-based healthy eating; Behavioral: Stretching exercise

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2C9
      • Goldring Centre for High Performance Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guidelines-based physical activity; 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening	Behavioral: Experimental: 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.
Experimental: Guidelines-based physical activity and healthy eating; 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide	Behavioral: Experimental: 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.; Behavioral: Experimental: 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.
Placebo Comparator: Stretching exercise; Whole-body stretching	Behavioral: Stretching exercise; Twice weekly virtual instructor-led whole-body stretching class.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Women's College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2022
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: March 4, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: primary prevention
• Other Study ID Numbers: 43521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No