Metabolic DisturbanceMs FITNCT05758857
Multiple Risk Factor Intervention Trial
A study testing Experimental: Guidelines-based physical activity, Experimental: Guidelines-based healthy eating and Stretching exercise in people with Metabolic Disturbance and Sedentary Behavior, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Metabolic Disturbance, Sedentary Behavior
- What is being tested?
- Experimental: Guidelines-based physical activity, Experimental: Guidelines-based healthy eating and Stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2022to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females
- pre- or postmenopausal
- aged 30+ years
- moderate or high Canadian Diabetes Risk Score score
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S 2C9
About this study
Official title: 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.
- Conditions
- Metabolic Disturbance, Sedentary Behavior
- Being tested
- Experimental: Guidelines-based physical activity, Experimental: Guidelines-based healthy eating, Stretching exercise
- Keywords
- primary prevention
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Guidelines-based physical activityBehavioural
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 eatingBehavioural
One-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide.
Stretching exerciseBehavioural
Twice weekly virtual instructor-led whole-body stretching class.
| Study group | Role | What they receive |
|---|---|---|
| Guidelines-based physical activity | Experimental | 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening Receives: Behavioral: Experimental: Guidelines-based physical activity |
| Guidelines-based physical activity and healthy eating | Experimental | 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide Receives: Behavioral: Experimental: Guidelines-based physical activity; Behavioral: Experimental: Guidelines-based healthy eating |
| Stretching exercise | Placebo comparator | Whole-body stretching Receives: Behavioral: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity intervention feasibility
Determined as an average adherence to physical activity guidelines of ≥100% measured via Garmin smartwatch
Measured: end of week 6
Diet quality intervention feasibility
Determined as a 5-point improvement in diet quality measured via healthy eating index from 3-day diet record
Measured: end of week 6
Intervention acceptability
Assessed via researcher-developed questionnaire
Measured: end of week 6
Secondary outcomes (16)
Systemic insulin resistance
As assessed by the Matsuda Index calculated from an oral glucose tolerance test
Measured: 6 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
calculated as: (fasting insulin*fasting glucose)/22.5
Measured: 6 weeks
Framingham 10-year risk (%)
Calculated using standardized scoring system
Measured: 6 weeks
Lipid profile
analyzed from blood
Measured: 6 weeks
C-Reactive Protein
analyzed from blood
Measured: 6 weeks
Blood pressure
Measured after several minutes of supine rest
Measured: 6 weeks
Aortic stiffness (central to femoral)
Measured via Shygmacor device
Measured: 6 weeks
Brachial artery endothelial function
Measured via flow-mediated dilatation test
Measured: 6 weeks
Cardiorespiratory fitness
Measured as peak volume of oxygen consumption via indirect calorimetry
Measured: 6 weeks
Whole-body fat and fat free mass
Measured by BodPod
Measured: 6 weeks
Body circumferences
Waist, hip and neck circumferences measured by inelastic tape
Measured: 6 weeks
Depressive symptoms
measured by Beck Depression Inventory; score ranges from 0-63 with a higher score indicating more severe depression
Measured: 6 weeks
Dietary intake
Assessed via ASA-24 3-day food records
Measured: 6 weeks
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.
Measured: 6 weeks
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
Measured: 6 weeks
Psychosocial stress
assessed by the perceived stress scale where individual scores can range from 0 to 40 with higher scores indicating higher perceived stress
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start6 Nov 2022
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm parallel-group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital
- Responsible party
- Principal investigator, Amy Kirkham, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758857
- Sponsor's protocol ID
- 43521
- Acronym
- Ms FIT
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Min A, De Barros Gonze B, Christensen RAG, Small SD, Williams JS, Gillen JB, Kirkham A. Characterizing enjoyment of high-intensity interval training in association with exercise exertion among inactive women with cardiometabolic risk factors: a randomized crossover study. Appl Physiol Nutr Metab. 2026 Aug 6. doi: 10.1139/apnm-2026-0058. Online ahead of print.
PubMed 42561455
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Risk Factor Intervention Trial: A Pilot Study
- ClinicalTrials.gov ID
- NCT05758857
- Acronym / sponsor ID
- Ms FIT / 43521
- Conditions
- Metabolic Disturbance, Sedentary Behavior
- Keywords
- primary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Women's College Hospital
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Guidelines-based physical activity | Experimental | Behavioral: Experimental: Guidelines-based physical activity150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening |
| Guidelines-based physical activity and healthy eating | Experimental | Behavioral: Experimental: Guidelines-based physical activity, Behavioral: Experimental: Guidelines-based healthy eating150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide |
| Stretching exercise | Placebo comparator | Behavioral: Stretching exerciseWhole-body stretching |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- females
- pre- or postmenopausal
- aged 30+ years
- moderate or high Canadian Diabetes Risk Score score
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Guidelines-based physical activityThrough 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. | Behavioural | Guidelines-based physical activity, Guidelines-based physical activity and healthy eating |
| Experimental: Guidelines-based healthy eatingOne-on-one phone/virtual counselling from a registered dietitian to change dietary habits to be in line with Canada's Food Guide. | Behavioural | Guidelines-based physical activity and healthy eating |
| Stretching exerciseTwice weekly virtual instructor-led whole-body stretching class. | Behavioural | Stretching exercise |
Primary outcome
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
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
Intervention acceptability
Time frame: end of week 6
Assessed via researcher-developed questionnaire
16 secondary outcomes
Systemic insulin resistance
Time frame: 6 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 6 weeks
Framingham 10-year risk (%)
Time frame: 6 weeks
Lipid profile
Time frame: 6 weeks
C-Reactive Protein
Time frame: 6 weeks
Blood pressure
Time frame: 6 weeks
Aortic stiffness (central to femoral)
Time frame: 6 weeks
Brachial artery endothelial function
Time frame: 6 weeks
Cardiorespiratory fitness
Time frame: 6 weeks
Whole-body fat and fat free mass
Time frame: 6 weeks
Body circumferences
Time frame: 6 weeks
Depressive symptoms
Time frame: 6 weeks
Dietary intake
Time frame: 6 weeks
Menopausal symptom presence and severity
Time frame: 6 weeks
Health-related quality of life
Time frame: 6 weeks
Psychosocial stress
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 42561455Min A, De Barros Gonze B, Christensen RAG, Small SD, Williams JS, Gillen JB, Kirkham A. Characterizing enjoyment of high-intensity interval training in association with exercise exertion among inactive women with cardiometabolic risk factors: a randomized crossover study. Appl Physiol Nutr Metab. 2026 Aug 6. doi: 10.1139/apnm-2026-0058. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Guidelines-based physical activity, Experimental: Guidelines-based healthy eating and Stretching exercise in people with Metabolic Disturbance and Sedentary Behavior, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity intervention feasibility (time frame: end of week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.