Makoyoh'Sokoi - The Wolf Trail Program Expansion Project - Supporting Indigenous Women to Celebrate Good Health

NCT05362435 | Recruiting

• 1 other identifier: 21-1305
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (5)

• Activation

  Participants' engagement in their own healthcare as measured by the Patient Activation Measure (PAM™). Patient activation implies a "willingness and ability to take independent actions to manage their health and care". The PAM™ score has been used to assess effectiveness of diabetes prevention programming in Indigenous populations. It is a well-validated tool to assess effectiveness of interventions for many chronic diseases and small increases in PAM score have been shown to correlate to reduced healthcare costs and improved health status. PAM™ levels are defined as follows: Level 1 \<47, Level 2 47.1 - 55.1, Level 3 55.2 - 67.0, Level 4 \>67.1. To assess changes in PAM™ scores over time the analysis will focus on score changes within each level. Previous studies show that most change occurs within the lowest levels of activation (Levels 1 and 2), and patients with lower activation also tend to have higher utilization and costs. So, both the PAM™ score and PAM™.

  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

  The investigators use pedometers to track weekly step counts. Pedometers were chosen to assess physical activity because they were successfully used in the previous MKS programs, provide immediate motivational feedback to participants, and are cost effective and validated. Pedometer use will be evaluated the following ways: 1) # who are compliant with bringing their pedometers weekly and # who have kept track of their total steps, 2) average % change in weekly step count between Time 2, Time 3 and Time 4 (or last class attended) (presented as mean +/- SD, median and range). 3) % reporting continued use of their pedometer at Time 5. 4)

  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

  The Neighbourhood - International Physical Activity Questionnaire (N-IPAQ) will be completed. The N-IPAQ is a reliable, validated, and easy to administer questionnaire that measures neighbourhood-based physical activity There are two forms of output from scoring the N-IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. For continuous variable such as weekly step counts, MET minutes, the mean (SD) will be shown and statistical methods including paired t-test and repeated measurement ANOVA, linear (mixed effect) regression methods will be used to discover whether the program participants will have more step counts over time. For categorical data such as the level of physical activity on the N- IPAQ, the frequency distribution will be presented and Chi-square test and generalized

  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

  Change in Mental Health Continuum-Short Form (MHC-SF) category uses three categories (languishing, moderate, flourishing) coded as 0, 1, and 2. % of participants in each category at T1, T4 and T5 will be reported along with change in category over time. Statistical method for example, two proportion test, and Chi-square tests will be used to identify whether the programming will improve the participants' well-being in three components: emotional, social, and psychological. In addition, the correlation analysis between this MHC-SF measures with other outcomes will help to reveal whether this outcome is correlated to variables such as the 12-item Short Form Survey (SF-12), Canadian Health Measures Survey GEN\_18, Patient Activation Measure (PAM) and BMI (kg/m2) etc. Generalized linear mixed model will also be used for the repeated measurements collected pre and post program considering other potential factors or outcomes as adjusting covariates in the model.

  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

  The Medicine Wheel is a visual tool to reflect the holistic view of balance in one's life. The four quadrants are comprised of Physical, Emotional, Mental, and Spiritual. Qualitative methods will be used to explore how the program has impacted where participants are with respect to the Medicine Wheel at the end of the program, using a Medicine Wheel Likert Scale. A peer-researcher will be identified during the second month of each program. The peer-researcher will be trained in the photo/video-voice method. Peer-researchers will meet with participants and educate the participant on how to create a photovoice/video to answer the question. The Medicine Wheel Likert Scale is incorporated into this reflective process. The peer-researcher will support them with editing and compile the exercises.

  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.

Secondary Outcomes (17)

• Participant cardiometabolic health - Metabolic Syndrome

  Presence of metabolic syndrome will be assessed 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).

• Participant cardiometabolic health - medication usage

  Medication use will be evaluated 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).

• Participant cardiometabolic health - resting heart rate

  Resting heart rate 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).

• Participant cardiometabolic health - smoking status

  Information on smoking status 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).

• Participant cardiometabolic health - CANRISK

  CANRISK scores will be calculated 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).

Study Arms (1)

Participation in Makoyoh'sokoi (the Wolf Trail Program)

EXPERIMENTAL

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.

Behavioral: Physical activity-based wellness programs

Interventions

Physical activity-based wellness programs BEHAVIORAL

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.

Participation in Makoyoh'sokoi (the Wolf Trail Program)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women, defined as gender female, and may include cis-female, binary, trans- females, queer and two-spirited individuals.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years old and older.

You may not qualify if:

• Pregnancy and breastfeeding.

Sponsors & Collaborators

• University of Calgary: lead
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (7)

Miskanawah

Calgary, Alberta, Canada

RECRUITING

Edmonton

Edmonton, Alberta, Canada

RECRUITING

Piikani First Nation

Piikani Nation, Alberta, Canada

RECRUITING

Flying Dust First Nation

Flying Dust First Nation, Saskatchewan, Canada

RECRUITING

Ministikwan Lake Cree Nation

Ministikwan Lake, Saskatchewan, Canada

RECRUITING

Onion Lake Health Centre

Onion Lake, Saskatchewan, Canada

RECRUITING

Waterhen Lake First Nation

Waterhen Lake, Saskatchewan, Canada

RECRUITING

Related Publications (12)

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  PMID: 21372804 BACKGROUND

• Deurenberg P, Weststrate JA, Seidell JC. Body mass index as a measure of body fatness: age- and sex-specific prediction formulas. Br J Nutr. 1991 Mar;65(2):105-14. doi: 10.1079/bjn19910073.

  PMID: 2043597 BACKGROUND

• Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/

  PMID: 33347096 BACKGROUND

• Forde C. Exercise Prescription for the Prevention and Treatment of Disease. Scoring the International Physical Activity Questionnaire (IPAQ). Trinity College Dublin, The University of Dublin. 2016. https://ugc.futurelearn.com/uploads/files/bc/c5/bcc53b14-ec1e-4d90-88e3-1568682f32ae/IPAQ_PDF.pdf

  BACKGROUND

• Frehlich L, Blackstaffe A, McCormack GR. Test-Retest Reliability and Walk Score(R) Neighbourhood Walkability Comparison of an Online Perceived Neighbourhood-Specific Adaptation of the International Physical Activity Questionnaire (IPAQ). Int J Environ Res Public Health. 2019 May 30;16(11):1917. doi: 10.3390/ijerph16111917.

  PMID: 31151210 BACKGROUND

• Halls, S.B. Body Fat Percentage: Find Out Yours. Halls.md. Body fat percentage formula from body mass index (halls.md). 2019.

  BACKGROUND

• Kading ML, Hautala DS, Palombi LC, Aronson BD, Smith RC, Walls ML. Flourishing: American Indian Positive Mental Health. Soc Ment Health. 2015 Nov;5(3):203-217. doi: 10.1177/2156869315570480. Epub 2015 Feb 2.

  PMID: 28966866 BACKGROUND

• Radandt NE, Corbridge T, Johnson DB, Kim AS, Scott JM, Coldwell SE. Validation of a Two-Item Food Security Screening Tool in a Dental Setting. J Dent Child (Chic). 2018 Sep 15;85(3):114-119.

  PMID: 30869587 BACKGROUND

• Sallis JF, Bowles HR, Bauman A, Ainsworth BE, Bull FC, Craig CL, Sjostrom M, De Bourdeaudhuij I, Lefevre J, Matsudo V, Matsudo S, Macfarlane DJ, Gomez LF, Inoue S, Murase N, Volbekiene V, McLean G, Carr H, Heggebo LK, Tomten H, Bergman P. Neighborhood environments and physical activity among adults in 11 countries. Am J Prev Med. 2009 Jun;36(6):484-90. doi: 10.1016/j.amepre.2009.01.031.

  PMID: 19460656 BACKGROUND

• Wicklum, S., Sampson, M., Henderson, R., Wiart, S., Perez, G., McGuire, A., Cameron, E., Willis, E., Crowshoe, L., McBrien, K. Results of a culturally relevant, physical activity-based wellness program for urban indigenous women in Alberta, Canada. International Journal of Indigenous Health. 2019; 14(2), 169-204. https://doi.org/10.32799/ijih.v14i2.31890.

  BACKGROUND

• Rao DP, Dai S, Lagace C, Krewski D. Metabolic syndrome and chronic disease. Chronic Dis Inj Can. 2014 Feb;34(1):36-45. English, French.

  PMID: 24618380 BACKGROUND

• Robinson CA, Agarwal G, Nerenberg K. Validating the CANRISK prognostic model for assessing diabetes risk in Canada's multi-ethnic population. Chronic Dis Inj Can. 2011 Dec;32(1):19-31.

  PMID: 22153173 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sonja Wicklum, MD CCFP FCFP

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Levi Frehlich, BSc (Hons), MSc, PhD Candidate

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Wicklum, MD CCFP FCFP

CONTACT

403-955-9300; Sonja.wicklum@ucalgary.ca

Carly Checholik, MSc

CONTACT

780-915-6086; carly.checholik@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a self-control, non-randomised intervention. Participant data collection will occur at the following times: Cohort A \& B T1 = 3 months pre-program T2 = Week 1 = immediately pre-program T3 = Week 12 = post live program (12 weeks) T4 = Week 24 = post full program T5 = 1 year after T4 Cohort C, D, E 3-month control removed after consultation. T1 = Week 1 = immediately pre-program T2 = Week 12 = post live program (12 weeks) T3 = Week 18 or 24 = post full program T4 = 1 year after T4 Data input will occur in March and July annually, there will be 5 cohorts over the three years (Jan 2022 \[COHORT A\], Sept 2022 \[COHORT B\], Jan 2023 \[COHORT C\], Sept 2023 \[COHORT D\], Jan 2024 \[COHORT E\]). Cohorts A, B, C will have all data points collected, cohorts D and E will not have data collected 1-year post completion (unless the researchers are able to extend funding to include the one-year follow-up for these cohorts). Each cohort will be exposed to the same intervention.

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: May 5, 2022
• Study Start: November 22, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

CA (7)