Multiple Risk Factor Intervention Trial

Sedentary Behavior Clinical Trial

— Ms FIT  

Official title:

Multiple Risk Factor Intervention Trial: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05758857
• Other study ID #: 43521
• Status: Completed
• Phase: N/A
• Start date: November 6, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: December 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disturbance
• Sedentary Behavior

Intervention

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 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.
• Stretching exercise
Twice weekly virtual instructor-led whole-body stretching class.

Locations

Country	Name	City	State
Canada	Goldring Centre for High Performance Sport	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Intervention acceptability	Assessed via researcher-developed questionnaire	6 months
Other	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
Other	Dietary intake	Assessed via ASA-24 3-day food records	6 months
Other	Depressive symptoms	measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression	6 months
Other	Body circumferences	Waist, hip and neck circumferences measured by inelastic tape	6 months
Other	Whole-body fat and fat free mass	Measured by BodPod	6 months
Other	Cardiorespiratory fitness	Measured as peak volume of oxygen consumption via indirect calorimetry	6 months
Other	Blood pressure	Measured after several minutes of supine rest	6 months
Other	Physical activity intervention feasibility	Determined as an average adherence to physical activity guidelines of =100% measured via Garmin smartwatch	6 months
Other	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
Primary	Physical activity intervention feasibility	Determined as an average adherence to physical activity guidelines of =100% measured via Garmin smartwatch	end of week 6
Primary	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
Primary	Intervention acceptability	Assessed via researcher-developed questionnaire	end of week 6
Secondary	Systemic insulin resistance	As assessed by the Matsuda Index calculated from an oral glucose tolerance test	6 weeks
Secondary	Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	calculated as: (fasting insulin*fasting glucose)/22.5	6 weeks
Secondary	Framingham 10-year risk (%)	Calculated using standardized scoring system	6 weeks
Secondary	Lipid profile	analyzed from blood	6 weeks
Secondary	C-Reactive Protein	analyzed from blood	6 weeks
Secondary	Blood pressure	Measured after several minutes of supine rest	6 weeks
Secondary	Aortic stiffness (central to femoral)	Measured via Shygmacor device	6 weeks
Secondary	Brachial artery endothelial function	Measured via flow-mediated dilatation test	6 weeks
Secondary	Cardiorespiratory fitness	Measured as peak volume of oxygen consumption via indirect calorimetry	6 weeks
Secondary	Whole-body fat and fat free mass	Measured by BodPod	6 weeks
Secondary	Body circumferences	Waist, hip and neck circumferences measured by inelastic tape	6 weeks
Secondary	Depressive symptoms	measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression	6 weeks
Secondary	Dietary intake	Assessed via ASA-24 3-day food records	6 weeks
Secondary	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
Secondary	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
Secondary	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