Physical activity-based wellness programs for Physical Inactivity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Miskanawah, Calgary, Canada
Physical Inactivity
Physical activity-based wellness programs - Behavioral
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will test a health education program called MKS+ designed to empower Indigenous women to improve their health. The program is delivered in community and increases self-efficacy and health literacy. The purpose of this study is to see if physical activity-based wellness programs can help treat physical inactivity. No patients in this trial will receive a placebo. The treatment can be done online. Physical activity-based wellness programs has previously been approved by the FDA for a different condition.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 17 Secondary · Reporting Duration: Food Security scores will be evaluated 3-months before the intervention begins (Time 1), immediately pre-program (Time 2), after the live program (12 weeks; Time 3), after the full program (24 weeks; Time 4), and 52 weeks after the full program (Time 5).

Week 24
Participant Nutrition - Traditional Foods
Week 52
Awareness and access to previously unused or unknown resources
Week 52
Participant anthropometrics
Attendance is tracked throughout the program and ultimately evaluated at the end of the 24-week program (Time 4).
Attendance
Week 52
Participant cardiometabolic health - CANRISK
Week 52
Physical Activity - Change in Step Counts
Week 52
Participant Nutrition - Health Education
Week 52
Participant quality of life, sense of belonging and mental health
Week 52
Participant Nutrition - Food Security
Week 52
Fitness - Grip Strength
Week 52
Participant Nutrition - Healthy Eating Index
Week 52
Participant cardiometabolic health - smoking status
Week 52
Participant cardiometabolic health - medication usage
Week 52
Activation
Week 52
Community walkability as perceived by participants
Presence of metabolic syndrome will be assessed 3-months before the program (Time 1), at the end of the 24-week program (Time 4), and one year after the full program (Time 5).
Participant cardiometabolic health - Metabolic Syndrome
Week 24
Change in participant quality of life, sense of belonging and mental health - Main
Week 52
Participant quality of life, sense of belonging and mental health - Main
Week 52
Participant quality of life, sense of belonging and mental health - Secondary
Week 52
Participant cardiometabolic health - resting heart rate
Week 52
Fitness - 1-mile walk test
Week 52
Physical Activity - Change in International Physical Activity Questionnaire Results

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Participation in Makoyoh'sokoi (the Wolf Trail Program)
1 of 1
Experimental Treatment

1250 Total Participants · 1 Treatment Group

Primary Treatment: Physical activity-based wellness programs · No Placebo Group · N/A

Participation in Makoyoh'sokoi (the Wolf Trail Program)
Behavioral
Experimental Group · 1 Intervention: Physical activity-based wellness programs · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: food security scores will be evaluated 3-months before the intervention begins (time 1), immediately pre-program (time 2), after the live program (12 weeks; time 3), after the full program (24 weeks; time 4), and 52 weeks after the full program (time 5).
Closest Location: Miskanawah · Calgary, Canada
Photo of Calgary 1Photo of Calgary 2Photo of Calgary 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Physical Inactivity
0 CompletedClinical Trials

Who is running the clinical trial?

Public Health Agency of Canada (PHAC)OTHER_GOV
38 Previous Clinical Trials
87,409 Total Patients Enrolled
University of CalgaryLead Sponsor
692 Previous Clinical Trials
448,579 Total Patients Enrolled
Levi Frehlich, BSc (Hons), MSc, PhD CandidatePrincipal InvestigatorUniversity of Calgary
Sonja Wicklum, MD CCFP FCFPPrincipal InvestigatorUniversity of Calgary

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References