Multiple Risk Factor Intervention Trial (Ms FIT)

December 1, 2023 updated by: Amy Kirkham, University of Toronto

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical activity intervention feasibility
Time Frame: end of week 6
Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch
end of week 6
Diet quality intervention feasibility
Time Frame: end of week 6
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
Time Frame: end of week 6
Assessed via researcher-developed questionnaire
end of week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systemic insulin resistance
Time Frame: 6 weeks
As assessed by the Matsuda Index calculated from an oral glucose tolerance test
6 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame: 6 weeks
calculated as: (fasting insulin*fasting glucose)/22.5
6 weeks
Framingham 10-year risk (%)
Time Frame: 6 weeks
Calculated using standardized scoring system
6 weeks
Lipid profile
Time Frame: 6 weeks
analyzed from blood
6 weeks
C-Reactive Protein
Time Frame: 6 weeks
analyzed from blood
6 weeks
Blood pressure
Time Frame: 6 weeks
Measured after several minutes of supine rest
6 weeks
Aortic stiffness (central to femoral)
Time Frame: 6 weeks
Measured via Shygmacor device
6 weeks
Brachial artery endothelial function
Time Frame: 6 weeks
Measured via flow-mediated dilatation test
6 weeks
Cardiorespiratory fitness
Time Frame: 6 weeks
Measured as peak volume of oxygen consumption via indirect calorimetry
6 weeks
Whole-body fat and fat free mass
Time Frame: 6 weeks
Measured by BodPod
6 weeks
Body circumferences
Time Frame: 6 weeks
Waist, hip and neck circumferences measured by inelastic tape
6 weeks
Depressive symptoms
Time Frame: 6 weeks
measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression
6 weeks
Dietary intake
Time Frame: 6 weeks
Assessed via ASA-24 3-day food records
6 weeks
Menopausal symptom presence and severity
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
Assessed via researcher-developed questionnaire
6 months
Menopausal symptom presence and severity
Time Frame: 6 months
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
Time Frame: 6 months
Assessed via ASA-24 3-day food records
6 months
Depressive symptoms
Time Frame: 6 months
measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression
6 months
Body circumferences
Time Frame: 6 months
Waist, hip and neck circumferences measured by inelastic tape
6 months
Whole-body fat and fat free mass
Time Frame: 6 months
Measured by BodPod
6 months
Cardiorespiratory fitness
Time Frame: 6 months
Measured as peak volume of oxygen consumption via indirect calorimetry
6 months
Blood pressure
Time Frame: 6 months
Measured after several minutes of supine rest
6 months
Physical activity intervention feasibility
Time Frame: 6 months
Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch
6 months
Diet quality intervention feasibility
Time Frame: 6 months
Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Women's College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings