NCT05758857

Multiple Risk Factor Intervention Trial

Multiple Risk Factor Intervention Trial: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Disturbance
• Sedentary Behavior

Interventions

Type	Name	Description
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.
BEHAVIORAL	Stretching exercise	Twice weekly virtual instructor-led whole-body stretching class.

Timeline

• Start date: 2022-11-06
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2023-03-08
• Last updated: 2023-12-04

Locations

1 site across 1 country: Canada