Multiple Risk Factor Intervention Trial (Ms FIT)

University of Toronto

Status: Completed

Conditions: Metabolic Disturbance; Sedentary Behavior

Treatments: Behavioral: Experimental: Guidelines-based healthy eating; Behavioral: Stretching exercise; Behavioral: Experimental: Guidelines-based physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05758857

43521

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

Guidelines-based physical activity

Experimental group

Description:

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening

Treatment:

Behavioral: Experimental: Guidelines-based physical activity

Guidelines-based physical activity and healthy eating

Experimental group

Description:

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide

Treatment:

Behavioral: Experimental: Guidelines-based physical activity

Behavioral: Experimental: Guidelines-based healthy eating

Stretching exercise

Placebo Comparator group

Description:

Whole-body stretching

Treatment:

Behavioral: Stretching exercise