180 Participants Needed

Exercise and Diet for Metabolic Disorders

(MsFIT Trial)

AA
JB
Overseen ByJenna B. Gillen, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise and diet might reduce heart and metabolic risks in women. Participants will join one of three groups: guidelines-based physical activity (exercise), guidelines-based physical activity combined with healthy eating, or stretching exercise. The trial aims to determine which combination works best, especially in relation to menopause status. Women who are mostly inactive, with higher body weight or conditions like high blood pressure or high blood sugar, might be suitable candidates. Participants must visit the university once a week for 24 weeks.

As an unphased trial, this study offers a unique opportunity to contribute to understanding lifestyle impacts on women's health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking weight loss medications, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that most adults can safely follow physical activity guidelines. Studies suggest that engaging in 150 minutes of moderate exercise each week improves cholesterol, blood pressure, and bone strength. This type of exercise is generally manageable and rarely causes serious side effects.

Incorporating healthy eating into an exercise routine is also safe. Following Canada's Dietary Guidelines, which emphasize balanced nutrition, supports overall health. Those who combine exercise with healthy eating often experience better health outcomes without major negative effects.

Both exercise alone and exercise combined with healthy eating rely on well-researched guidelines. These guidelines have been tested and found safe for many people, including older adults. Therefore, participants in the trial can expect these activities to be safe.12345

Why are researchers excited about this trial?

Researchers are excited about the exercise and diet protocols for metabolic disorders because they combine regular, structured physical activity with healthy eating habits, which isn't commonly emphasized in current treatments. While most treatments focus on medication or isolated lifestyle changes, this approach integrates 150 weekly minutes of moderate-intensity aerobic activity and muscle strengthening with dietary guidance from Canada's Food Guide. This dual-focus strategy aims to tackle metabolic disorders holistically, potentially offering a more sustainable and effective way to manage these conditions compared to standard medication or diet-alone strategies. Additionally, the inclusion of stretching as a placebo comparator highlights the specific impact of these comprehensive lifestyle changes.

What evidence suggests that this trial's treatments could be effective for cardiometabolic risk reduction in women?

This trial will compare different approaches to improving health through exercise and diet. Participants in one arm will engage in guidelines-based physical activity, which includes 150 weekly minutes of moderate-intensity aerobic activity and twice-weekly whole-body muscle strengthening. Another arm will combine this physical activity with healthy eating, including counseling to follow Canada's Food Guide. A third arm will focus on stretching exercises as a comparator. Studies have shown that regular physical activity can lower the risk of heart disease and improve health by reducing cholesterol, lowering blood pressure, and strengthening the heart and lungs. Research indicates that combining exercise with a healthy diet can further reduce disease risk and improve overall health. Eating well can enhance the benefits of exercise, leading to a healthier heart and less body fat. The evidence is clear: staying active and eating a balanced diet are powerful ways to improve health and prevent disease.23678

Who Is on the Research Team?

Amy Kirkham Profile | University of Toronto

Amy A Kirkham, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for pre and postmenopausal women who are dealing with metabolic disorders due to a sedentary lifestyle. Participants should be interested in improving their health through physical activity and possibly dietary changes.

Inclusion Criteria

High CANRISK score (score of ≥33) as determined by the online CANRISK tool
I can visit the University weekly for 6 months.
I am either before or after menopause.
See 1 more

Exclusion Criteria

My BMI is over 40.
Exceeding self-reported moderate-to-vigorous intensity aerobic physical activity
Diagnosed history of an eating disorder or self-report of potential undiagnosed eating disorder
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three groups: exercise following Health Canada guidelines, exercise plus dietary counseling, or a stretching group for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Guidelines-based physical activity
  • Guidelines-based physical activity and healthy eating
  • Stretching exercise
Trial Overview The study tests three approaches: 1) exercise following Health Canada guidelines, 2) the same exercise plus healthy eating advice, or 3) just stretching exercises. It aims to see how these affect heart and metabolic health differently before and after menopause.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Guidelines-based physical activity and healthy eatingExperimental Treatment1 Intervention
Group II: Guidelines-based physical activityExperimental Treatment1 Intervention
Group III: Stretching exercisePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials
739
Recruited
1,125,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Published Research Related to This Trial

Regular moderate-intensity physical activity, as recommended by Canadian and international guidelines, can significantly reduce the risk of over 25 chronic conditions, including heart disease, stroke, and certain cancers.
If the Canadian population adhered to these physical activity guidelines, it is estimated that a substantial number of deaths from chronic diseases could be prevented, highlighting the critical role of physical activity in public health.
Evidence-informed physical activity guidelines for Canadian adults.Warburton, DE., Katzmarzyk, PT., Rhodes, RE., et al.[2018]
A survey of 6,536 adults in Manitoba found that 69.5% met the minimum physical activity requirements set by Canada's Physical Activity Guide to Healthy Active Living (CPAG), indicating a positive trend in activity levels compared to previous surveys.
However, only 29.1% of respondents achieved these levels through vigorous activity, suggesting that while many are active, the intensity of their activities may not be sufficient to combat rising obesity and chronic disease rates, prompting a recommendation to review CPAG guidelines to better include daily living activities.
Canada's physical activity guide recommendations are a low benchmark for Manitoba adults.Ready, AE., Butcher, JE., Dear, JB., et al.[2016]
Regular moderate-intensity physical activity, as recommended by Canadian and international guidelines, can significantly reduce the risk of over 25 chronic conditions, including heart disease, stroke, and certain cancers.
If the Canadian population adhered to these physical activity guidelines, it is estimated that a substantial number of deaths from chronic diseases could be prevented, highlighting the critical role of physical activity in public health.
[Evidence-based guidelines for physical activity of adult Canadians].Warburton, DE., Katzmarzyk, PT., Rhodes, RE., et al.[2016]

Citations

Advancing the future of physical activity guidelines in CanadaThere is extensive research supporting the importance of regular physical activity (PA) in reducing all-cause mortality and improving several health outcomes.
A systematic review of the evidence for Canada's Physical ...We revealed strong evidence that routine physical activity was effective in the primary prevention of cardiovascular disease, stroke, hypertension, breast ...
2025 Canadian guideline for physical activity, sedentary ...We suggest limiting sedentary time to 8 hours or less, including no more than 3 hours of recreational screen time, and breaking up long periods of sitting when ...
New Canadian Physical Activity GuidelinesFollowing these physical activity guidelines can improve cholesterol levels, blood pressure, body composition, bone density, cardiorespiratory and ...
A systematic review of physical activity interventions to ...The purpose of this review was to evaluate and review physical activity interventions delivered among Indigenous populations in Canada to assess their impact on ...
World Health Organization 2020 guidelines on physical ...All adults should undertake 150–300 min of moderate-intensity, or 75–150 min of vigorous-intensity physical activity, or some equivalent combination of moderate ...
(PDF) New Canadian Physical Activity Guidelinesenjoyable and safe. Older adults can meet these guidelines through planned. exercise ... Health Canada and the Canadian Society for Exercise ...
World Health Organization 2020 guidelines on physical ...All adults should undertake 150–300 min of moderate-intensity, or 75–150 min of vigorous-intensity physical activity, or some equivalent combination of moderate ...
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