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Multiple Risk Factor Intervention Trial

NCT ID: NCT05758857

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-06

Study Completion Date

2023-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Disturbance Sedentary Behavior

Keywords

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primary prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3-arm parallel-group randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment.

Study Groups

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Guidelines-based physical activity

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

Group Type EXPERIMENTAL

Experimental: Guidelines-based physical activity

Intervention Type 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.

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

Group Type EXPERIMENTAL

Experimental: Guidelines-based physical activity

Intervention Type 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

Intervention Type 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

Whole-body stretching

Group Type PLACEBO_COMPARATOR

Stretching exercise

Intervention Type BEHAVIORAL

Twice weekly virtual instructor-led whole-body stretching class.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Stretching exercise

Twice weekly virtual instructor-led whole-body stretching class.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women's College Hospital

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Amy Kirkham

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Goldring Centre for High Performance Sport

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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43521

Identifier Type: -

Identifier Source: org_study_id