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Health Education Program for Sedentary Lifestyle (MKS+ Trial)

N/A

Recruiting

Led By Sonja Wicklum, MD CCFP FCFP

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old and older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up food security scores will be evaluated immediately pre-program (week1; time 1), after the live program (12 weeks; time 2), after the full program (week 18 or 24; time 3), and 52 weeks after the full program (week 70 or 76; time 4).

Awards & highlights

MKS+ Trial 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.

Who is the study for?

The Wolf Trail Program is for Indigenous women over 18 from specific communities in Alberta and Saskatchewan. It's open to those identifying as Métis, First Nations, or Inuit, including cis-female, binary, trans-females, queer and two-spirited individuals. Pregnant or breastfeeding women cannot participate.Check my eligibility

What is being tested?

This program tests a wellness approach combining physical activity with health education on nutrition and prevention. Participants will also connect with local healthcare providers and Indigenous cultural elements to improve overall health literacy and self-management skills.See study design

What are the potential side effects?

While this program doesn't involve medication that typically has side effects, participants may experience muscle soreness or fatigue due to increased physical activity. Emotional discomfort could arise when engaging with new health information or cultural activities.

MKS+ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

MKS+ Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in step-counts will be studies between the start of the program (week 1; time 1), the end of the live program (week 12; time 2), the end of the follow-up period (week 18 or 24; time 3), and 52 weeks after the full program (week 70 or 76; time 4).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in step-counts will be studies between the start of the program (week 1; time 1), the end of the live program (week 12; time 2), the end of the follow-up period (week 18 or 24; time 3), and 52 weeks after the full program (week 70 or 76; time 4).

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in step-counts will be studies between the start of the program (week 1; time 1), the end of the live program (week 12; time 2), the end of the follow-up period (week 18 or 24; time 3), and 52 weeks after the full program (week 70 or 76; time 4). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Activation

Change in participant quality of life, sense of belonging and mental health - Main

Participant quality of life, sense of belonging and mental health - Main

+2 more

Secondary outcome measures

Attendance

Awareness and access to previously unused or unknown resources

Community walkability as perceived by participants

+14 more

MKS+ Trial Design

1Treatment groups

Experimental Treatment

Group I: Participation in Makoyoh'sokoi (the Wolf Trail Program)Experimental Treatment1 Intervention

This is a self-control, non-randomised intervention study. 7 locations will run a total of 10 programs (4 urban, off-reserve; 6 rural, on reserve). Makoyoh'sokoi (The Wolf Trail Program) is a holistic health and wellness program that consists of a 12-week live phase where participants engage weekly in approximately 45 minutes of physical activity, 20 minutes of a health education module, and 20 minutes of a sharing circle. The live phase is followed by a 12-week follow-up phase where participants meet bi-weekly for approximately 30 minutes of a health education module and 30 minutes of a sharing circle.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Public Health Agency of Canada (PHAC)OTHER_GOV

45 Previous Clinical Trials

95,883 Total Patients Enrolled

1 Trials studying Sedentary Lifestyle

118 Patients Enrolled for Sedentary Lifestyle

University of CalgaryLead Sponsor

792 Previous Clinical Trials

867,904 Total Patients Enrolled

Sonja Wicklum, MD CCFP FCFPPrincipal InvestigatorUniversity of Calgary

Media Library

Physical activity-based wellness programs Clinical Trial Eligibility Overview. Trial Name: NCT05362435 — N/A

Sedentary Lifestyle Research Study Groups: Participation in Makoyoh'sokoi (the Wolf Trail Program)

Sedentary Lifestyle Clinical Trial 2023: Physical activity-based wellness programs Highlights & Side Effects. Trial Name: NCT05362435 — N/A

Physical activity-based wellness programs 2023 Treatment Timeline for Medical Study. Trial Name: NCT05362435 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective of this investigation?

"This clinical trial plans to assess the Change in step-counts as well as three primary outcomes: Participant quality of life, sense of belonging and mental health (evaluated using EQ-5D- 5L™), smoking status, and medication usage. Descriptive statistics will be presented with mean (SD) and frequency for categorical data, while t-tests, ANOVAs, mixed effect models, linear regression models with mixed effects, Paretian Classification of Health Change (PCHC), and Health Profile Grid (HPG) are planned for further analysis."

Answered by AI

What is the population size for this research investigation?

"Affirmative. As per the listing on clinicaltrials.gov, this medical trial is actively seeking participants to join in its research endeavour. The study was first announced on November 22nd 2021 and has been amended as recently as May 16th 2022; 1250 patients must be recruited from 7 different centres."

Answered by AI

What are the locations where this clinical experiment is currently being conducted?

"The medical trial is currently open to recruitment at 7 different sites, including Piikani First Nation in Piikani Nation, Onion Lake Health Centre in Onion Lake and Edmonton in Edmonton."

Answered by AI

Does this research still need additional participants?

"Affirmative. According to clinicaltrials.gov, this trial is actively looking for participants and was initially posted on November 22nd 2021 with its last update occurring May 16th 2022. Currently 1250 patients are being sought across 7 different locations."

Answered by AI

Recent research and studies

British Journal of NutritionJournal

Body Mass Index as a Measure of Body Fatness: Age- and Sex-specific Prediction Formulas

Deurenberg, Paul, Jan A. Weststrate, and Jaap C. Seidell. 1991. “Body Mass Index as a Measure of Body Fatness: Age- and Sex-specific Prediction Formulas”. British Journal of Nutrition. Cambridge University Press (CUP). doi:10.1079/bjn19910073.

Methods for Analysing and Reporting EQ-5D DataJournal

Devlin, Nancy, David Parkin, and Bas Janssen. <i>Methods for Analysing and Reporting EQ-5D Data</i>. Springer International Publishing, 2020. <i>Crossref</i>. Web. <https://doi.org/10.1007/978-3-030-47622-9>..

Devlin, Nancy, David Parkin, and Bas Janssen. 2020. Methods for Analysing and Reporting EQ-5D Data. []. Springer International Publishing. doi:10.1007/978-3-030-47622-9.

American Journal of Preventive MedicineJournal

Neighborhood Environments and Physical Activity Among Adults in 11 Countries

Sallis, James F., Heather R. Bowles, Adrian Bauman, Barbara E. Ainsworth, Fiona C. Bull, Cora L. Craig, Michael Sjöström, et al.. 2009. “Neighborhood Environments and Physical Activity Among Adults in 11 Countries”. American Journal of Preventive Medicine. Elsevier BV. doi:10.1016/j.amepre.2009.01.031.

ObesityJournal