NCT05362435 Makoyoh'Sokoi - The Wolf Trail Program Expansion Project - Supporting Indigenous Women to Celebrate Good Health
| NCT ID | NCT05362435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Physical Inactivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2021-11-22 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,250 participants in total. It began in 2021-11-22 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
During the MKS+ program participants complete health education modules that expose them to health information, a substantial portion of which relate to healthy nutrition and prevention, and on occasion to local healthcare providers. The goal is to increase activation and the ability to manage one's own health. In each community, the Community Organisational Leads will support the Facilitators to establish a comprehensive resource list of healthcare professionals. Additionally, through exposure to local Indigenous Knowledge Keepers and Elders, along with cultural and spiritual elements, the participants will know how to access activities that may further support their wellness. The MKS+ program shows promise as a community-based model for supporting Indigenous women to improve their health. It is grounded in community; increases self-efficacy through the opportunity to learn, practice, and share in manageable increments; and increases health literacy through program contents and coordinating healthcare knowledge exchange with other healthcare providers from the community. By connecting to aspects of Indigenous culture, participants can be affirmed in their identities and learn more about how connecting to culture may be protective of their health through a restored sense of self-worth, sharing, and community support. At the individual participant level the investigators anticipate the participants will a) improve their fitness, body composition and cardiometabolic health, b) improve their quality of life and mental health, c) develop strong support networks, d) be exposed to cultural elements in their community that the participants were not previously aware of that may lead to engagement, better understanding and easier access to their community resources, e) learn about healthy diet composition - shopping, cooking, and meal planning which will lead to improved nutrition, and f) understand the importance of health screening and smoking cessation. The investigators' earlier pilot work established these outcomes and the investigators are hopeful because this project will support an extended program that will include an additional 12 weeks of less intense, follow-up programming, that the investigators will also find that these elements are sustained at one-year post-programming. In previous grants, the investigators have never had the opportunity to extend the program in this way.
Eligibility Criteria
Inclusion Criteria: * Indigenous women from the following participating communities in rural and urban Alberta and Saskatchewan: Calgary (3 communities), Edmonton, Onion Lake Cree Nation, Waterhen Lake First Nation, Flying Dust First Nation, Ministikwan Lake Cree Nation, and Piikani Nation. * Indigenous women may identify as Métis, First Nations or Inuit, living both on- and off-reserve * Women, defined as gender female, and may include cis-female, binary, trans- females, queer and two-spirited individuals. * 18 years old and older. Exclusion Criteria: * Pregnancy and breastfeeding.
Frequently Asked Questions
Who can join the NCT05362435 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Physical Inactivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05362435 currently recruiting?
Yes, NCT05362435 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Calgary to inquire about joining.
Where is the NCT05362435 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Piikani Nation, Canada, Flying Dust First Nation, Canada and 1 additional location.
Who is sponsoring the NCT05362435 clinical trial?
NCT05362435 is sponsored by University of Calgary. The trial plans to enroll 1,250 participants.