Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05362435

Conditions

Physical Inactivity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Physical activity-based wellness programs

Study Details

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.

Conditions

Physical Inactivity

Study ID

NCT05362435

Start date

Nov 22, 2021

Status verified date

Jan, 2025

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Participation in Makoyoh'sokoi (the Wolf Trail Program)

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.

Interventions

Physical activity-based wellness programs

Each MKS+ program has 20-25 participants and consists of the following: 12 Week INTENSE PHASE: 1) pre-program information and orientation session, and data collection/testing; 2) core weekly programming with the following three components: a) 45-60 minute exercise class, b) 15-20 minute nutrition and wellness education, and c) 15-30 minute sharing circle; 3) end of program celebration; 4) urban poling sessions; 5) introduction to local healthcare providers as identified as relevant for the group; 6) ongoing online support via private Facebook group; 7) daily pedometer tracking to provide immediate motivational feedback to participants. 6-12 Week FOLLOW-UP PHASE: 1) Program Facilitator contacts participants weekly to encourage healthy activities, address concerns as needed, and record weekly step counts; 2) encourages continued engagement in private Facebook group; 3) 15-30 minute nutrition and wellness education, and c) 15-45 minute sharing circle.

Primary outcome measure

  • Activation [ Time Frame: PAM scores will be collected immediately pre-program (Week 1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). ]
  • Physical Activity - Change in Step Counts [ Time Frame: 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). ]
  • Physical Activity - Change in International Physical Activity Questionnaire Results [ Time Frame: The N-IPAQ will be completed 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). ]
  • Participant quality of life, sense of belonging and mental health - Main [ Time Frame: Responses will be collected immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). ]
  • Change in participant quality of life, sense of belonging and mental health - Main [ Time Frame: Qualitative research will happen after the full program (Week 18 or 24; Time 3) and one year after the full program (Week 70 or 76; Time 4) to determine change in quality of life. ]

Central Contacts and Locations

Central contacts

Locations

Miskanawah

Recruiting

Calgary, Alberta, Canada

Edmonton

Recruiting

Edmonton, Alberta, Canada

Piikani First Nation

Recruiting

Piikani Nation, Alberta, Canada

Flying Dust First Nation

Recruiting

Flying Dust First Nation, Saskatchewan, Canada

Ministikwan Lake Cree Nation

Recruiting

Ministikwan Lake, Saskatchewan, Canada

Onion Lake Health Centre

Recruiting

Onion Lake, Saskatchewan, Canada

Waterhen Lake First Nation

Recruiting

Waterhen Lake, Saskatchewan, Canada

More Information

Sponsor

University of Calgary

Last update posted

Jan 7, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-01-07.