Clinical trial NCT05362435: Makoyoh'Sokoi - The Wolf Trail Program Expansion Project - Supporting Indigenous Women to Celebrate Good Health
Official title: Expansion and Spread of Makoyoh'Sokoi, the Wolf Trail, a Community Led, Culturally Relevant, Physical Activity-based, Holistic Wellness Program for Indigenous Women; a Self-control, Non- Randomized, Intervention Trial in Seven Communities (10 Sites) in Alberta and Saskatchewan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2022-05-05
Enrollment: 1250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The Makoyoh'sokoi (Wolf Trail) Program is a holistic wellness program that is highly integrated both in its capacity as a program and in its mission to support its participants. In doing so the program has multiple areas of evaluation. The focus of the program evaluation is on making the evaluative measurements meaningful to either the participants or the community. The evaluative elements will be woven into the education components of the program so that each element/result is presented to a participant in such a way that it is meaningful to them and will assist them in their health journey. All elements not directly meaningful to either participants or the community have been reviewed, justified and agreed upon by community leads.

Participants will be women of all ages, 18 and older. The benefit of being inclusive of all ages is that there is intergenerational knowledge sharing and support, and role modelling can occur. In previous programs having a wide range of ages was always seen as a benefit for this reason and not as a deficit, despite the varied abilities to perform the physical exercise. To deal with the latter, the fitness instructors are well versed on adapting the exercises to the participants based on ability. An evaluation of the role of past participants from Lloydminster revealed that, on average, the program participants were responsible for food, clothing and care of 7-8 individuals each (research by Megan Sampson, Master's student), many caring for multiple generations and multiple families. The age of participants in all previous programming varied, the means ranged from 37-39 years old.

As this is a self-control, non-randomised study, with an evaluative component, no pre-set power calculations were made. Sample size is based largely on the size of the room available to host the classes along with the budget and available in-kind resources with a target of 25 participants initially enrolled and 20 completing each program. 25 participants will be recruited for each program, if individuals do not complete all the T1 measures then new individuals will be taken from the waiting list. If individuals drop out within the first 3 weeks, then new individuals will be taken from the waiting list. The goal will be to have 20 women complete each program. The investigators will need to define completion. The program is 24 weeks long with a total of 18 sessions.

All of the quantitative data will show descriptive statistics including mean, standard deviation (SD), or median with inter-quantile range (IQR) for continuous data and counts with percentages for categorical data. Statistical testing and modeling methods including t-test (continuous data) and chi-square test (for categorical data) will be applied to evaluate changes in key measures pre- and post programming. Nonparametric methods for example Mann-Whitney test, Kruskal-Wallis test and Mood's median test will be applied where the continuous data show significant skewness or pattern far from normal distribution. Repeated measurements ANOVA and other longitudinal models including linear mixed model or generalized linear mixed model or quantile regression (depending on outcomes' distributions) will be used to identify factors that drive the changes of key outcomes collected at T1 - T4. In addition, machine learning methods, for example, k-means clustering, regression tree or random forest, will be employed to identify subgroups with different patterns of changes in multiple outcomes through the programming. The investigators are especially interested to investigate which group(s) of patients have significant improvement in physical activities and health outcomes, and which group(s) don't have changes in outcomes. If presence of missing values and drop-outs, some inverse probability weighted likelihood methods may be used to consider the informative messiness.

All data will be collected on-site or through Qualtrics (online) for this study. The post-program data will be collected on-site also. If participants are unable to attend the class during which measurements will be completed, then the participants will be called and arrangements will be made for them to meet with the facilitator within two weeks of that date.

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.

Primary outcomes:
measure: Activation
timeFrame: 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).
measure: Physical Activity - Change in Step Counts
timeFrame: 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).
measure: Physical Activity - Change in International Physical Activity Questionnaire Results
timeFrame: 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).
measure: Participant quality of life, sense of belonging and mental health - Main
timeFrame: 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).
measure: Change in participant quality of life, sense of belonging and mental health - Main
timeFrame: 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:
measure: Participant cardiometabolic health - Metabolic Syndrome
timeFrame: 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).
measure: Participant cardiometabolic health - medication usage
timeFrame: 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).
measure: Participant cardiometabolic health - resting heart rate
timeFrame: 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).
measure: Participant cardiometabolic health - smoking status
timeFrame: 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).
measure: Participant cardiometabolic health - CANRISK
timeFrame: 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).
measure: Participant anthropometrics
timeFrame: Anthropometric measures 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).
measure: Fitness - Grip Strength
timeFrame: Grip strength 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).
measure: Fitness - 1-mile walk test
timeFrame: The 1-mile walk test 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).
measure: Participant quality of life, sense of belonging and mental health
timeFrame: EQ-5D-5L 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).
measure: Community walkability as perceived by participants
timeFrame: PANES scores will be 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).
measure: Participant quality of life, sense of belonging and mental health - Secondary
timeFrame: Responses will be will be collected 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).
measure: Participant Nutrition - Healthy Eating Index
timeFrame: HEI scores will be 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).
measure: Participant Nutrition - Traditional Foods
timeFrame: A summary of traditional food consumption immediately pre-program (Week 1; Time 1) and after the full program (Week 18 or 24; Time 3) will be completed.
measure: Participant Nutrition - Health Education
timeFrame: Changes in nutrition knowledge will be summarized and evaluated after the full program (Week 18 or 24; Time 3) and 52 weeks after the full program (Week 70 or 76; Time 4).
measure: Participant Nutrition - Food Security
timeFrame: 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).
measure: Awareness and access to previously unused or unknown resources
timeFrame: Access to resources 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).
measure: Attendance
timeFrame: Attendance is tracked throughout the program and ultimately evaluated at the end of the program (Week 18 or 24; Time 3).
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Miskanawah
state: Alberta
city: Edmonton
country: Canada
facility: Edmonton
state: Alberta
city: Piikani Nation
country: Canada
facility: Piikani First Nation
state: Alberta
city: Flying Dust First Nation
country: Canada
facility: Flying Dust First Nation
state: Saskatchewan
city: Ministikwan Lake
country: Canada
facility: Ministikwan Lake Cree Nation
state: Saskatchewan
city: Onion Lake
country: Canada
facility: Onion Lake Health Centre
state: Saskatchewan
city: Waterhen Lake
country: Canada
facility: Waterhen Lake First Nation
state: Saskatchewan
Study officials:
affiliation: University of Calgary
name: Sonja Wicklum, MD CCFP FCFP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Levi Frehlich, BSc (Hons), MSc, PhD Candidate
role: PRINCIPAL_INVESTIGATOR
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