AzTrials
AzTrials

Physical InactivityMKS+NCT05362435

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

A study testing Physical activity-based wellness programs in people with Physical Inactivity, run by University of Calgary at 7 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Physical Inactivity
What is being tested?
Physical activity-based wellness programs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,250 participants
Where
7 sitesCanada
Study dates
22 Nov 2021to Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnancy and breastfeeding.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sonja Wicklum, MD CCFP FCFP contact

403-955-9300

Sonja.wicklum@ucalgary.ca

Carly Checholik, MSc contact

780-915-6086

carly.checholik@ucalgary.ca

7 sites in 1 country

Canada7 sites, 7 recruiting

  • Miskanawah

    Calgary, Alberta

    Dawn Boustead

    Recruiting

  • Edmonton

    Edmonton, Alberta

    Delilah Mah

    Recruiting

  • Flying Dust First Nation

    Flying Dust First Nation, Saskatchewan

    Shelly Rowland

    Recruiting

  • Ministikwan Lake Cree Nation

    Ministikwan Lake, Saskatchewan

    Carol Linton

    Tammy Shakotko

    Recruiting

  • Onion Lake Health Centre

    Onion Lake, Saskatchewan

    Alicia Oliver

    Recruiting

  • Piikani First Nation

    Piikani Nation, Alberta

    Lana Potts

    Recruiting

  • Waterhen Lake First Nation

    Waterhen Lake, Saskatchewan

    Lena Crighton

    Aima Vincent

    Recruiting

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Physical activity-based wellness programs
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity-based wellness programsBehavioural

    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.

Study groups in NCT05362435
Study groupRoleWhat they receive
Participation in Makoyoh'sokoi (the Wolf Trail Program)ExperimentalThis 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.
Receives: Behavioral: Physical activity-based wellness programs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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™.

    Measured: 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).

  2. 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)

    Measured: 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).

  3. 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

    Measured: 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).

  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.

    Measured: 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).

  5. 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.

    Measured: 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)

  1. Participant cardiometabolic health - Metabolic Syndrome

    Blood pressure, waist circumference, biochemistries, and demographic data will be collected to determine prevalence of Metabolic Syndrome (MetS) and whether this changes throughout the program.

    The revised National Cholesterol Education Program Adult Treatment Panel III criteria, state that metabolic syndrome is present if three or more of the following criteria are met: abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)- numbers vary based on ethnicity; elevated plasma triglyceride level (≥ 1.7 mmol/L); decreased high-density lipoprotein (HDL) cholesterol level (< 1.03 mmol/L for men and < 1.30 mmol/L for women); elevated blood pressure (≥ 130/85 mm Hg); or elevated fasting glucose level (≥ 6.1 mmol/L).

    Report % with Met Syndrome initially for whom health improved such that they did not meet criteria at Time 4 (immediately post-program) and Time 5 (52 weeks post the end of the program).

    Measured: 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).

  2. Participant cardiometabolic health - medication usage

    As part of the investigators' understanding of participant cardiometabolic health, we will collect information on participant medication usage; decreasing or initiating medications for diabetes or cardiovascular risk reduction

    The descriptive statistics will be presented with mean (SD) and frequency for categorical data. The changes in those measures be analyzed by using a variety of methods such as t-test, repeated ANOVA and mixed effect model for continuous data and generalized linear mixed effect model regression for any categorized variables.

    Measured: 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).

  3. Participant cardiometabolic health - resting heart rate

    Resting heart rate will be evaluated as an indicator of cardiometabolic health. A lower resting heart rate at subsequent measures will be considered a sign of improved fitness. Resting heart rate is also required as part of the calculation for the 1-mile walk test.

    The descriptive statistics will be presented with mean (SD) and frequency for categorical data. The changes in those measures be analyzed by using a variety of methods such as t-test, repeated ANOVA and mixed effect model for continuous data and generalized linear mixed effect model regression for any categorized variables.

    Measured: 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).

  4. Participant cardiometabolic health - smoking status

    Information on smoking status, and changes to smoking status throughout the program, will be collected through a questionnaire. Reduced smoking frequency and smoking cessation will be viewed as a positive health change.

    The descriptive statistics will be presented with mean (SD) and frequency for categorical data. The changes in those measures be analyzed by using a variety of methods such as t-test, repeated ANOVA and mixed effect model for continuous data and generalized linear mixed effect model regression for any categorized variables.

    Measured: 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).

  5. Participant cardiometabolic health - CANRISK

    Canadian Diabetes Risk Questionnaire (CANRISK) score

    Composed of 12 questions, CANRISK collects information on the following risk factors: age group, sex, ethnicity, education, BMI (kg/m2), waist circumference, daily physical activity, daily fruit and vegetable consumption, history of high blood pressure, blood sugar, family history of diabetes, smoking status and macrosomia.

    The CANRISK Survey evaluates diabetes risk as "low risk" (a score lower than 21), "moderate risk" (a score of 21-32), and "high risk" (a score of 33 and over).

    Report % of participants who did not have known Type-2 Diabetes Mellitus, who increased, decreased or experienced no change in CANRISK score.

    Measured: 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).

  6. Participant anthropometrics

    Body-composition measures such as weight, height, and waist circumference will be collected, and then the investigators will calculate BMI (kg/m2), body adiposity index (BAI), and body fat percentage by using: body fat percentage= (1.20 X BMI) + 0.23 X age -5.4 (females with age >15). The data will be summarized with mean (SD) and median (IQR) for each time point at Time 1 (3 months pre-program) to Time 5 (1 year after the end of the program). The changes over time will also be evaluated by using longitudinal modeling methods (such as mixed effect model) as well as repeated measure ANOVA. The weight scale used uses impedance methods to calculate a % body fat but is limited at higher percentages. The investigators will compare percent body fat using both methods. Categorized BMI or body fat percentage based on WHO's method will be also presented with frequency and generalized linear mixed effect model will be applied to evaluate the changes over time from Time 1 to Time 5.

    Measured: 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).

  7. Fitness - Grip Strength

    Grip strength is found to correlate to longevity and fitness, and as participants are exposed to strength-based trainings, the investigators will use handgrip dynamometer to track the changes in strength of participants. This data will be presented with mean (SD) in different age groups and the % change from the previous time points. Linear regression will be used to evaluate whether significant changes in grip strength are observed among participants throughout and after the program the program.

    Measured: 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).

  8. Fitness - 1-mile walk test

    For 1-Mile Walk Test, the data of total minutes and VO2_MAX will be calculated and presented with mean -/+ SD and the categorized data based on VO2_max are also be presented with their frequency distribution in different age groups. The changes in the measures will be evaluated based on repeated ANOVA methods and linear regression by adjusting for potential factors such as age, smoking status, BMI and so on. To perform the 1-mile walking test: 1) Warm up for 5-10 minutes. 2) Start your stopwatch and start walking as fast as you can. 3) At the end of 1 mile, record your time in decimals. 4) Take your heart rate immediately. 5) Calculate VO2_max with provided formula (VO2 max = 132.853 - (0.0769 x your weight in pounds) - (0.3877 x your age) + (6.315 if you are male or 0 if you are female) - (3.2649 x your walking time) - (0.1565 x your heart rate at the end of the test)) 6) Determine the different levels based on the provided table.

    Measured: 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).

  9. Participant quality of life, sense of belonging and mental health

    Improvements in quality of life will be assessed using the EQ-5D- 5L™. The investigators are going to collect three measure from EQ-5D-5L: EQ5D profile, EQ5D Vas, EQ5D measures. In addition to presenting descriptive statistics including mean (SD) and frequencies in each level for all those measures at each time points and use t-test to evaluate the changes, longitudinal analysis will be conducted to check the changes of health state before and after the intervention. Paretian Classification of Health Change (PCHC) and Health Profile Grid (HPG) will be used to summarize the change of the profile data. Linear regression models with mixed effect for both VAS and EQ5D dimension can be used to evaluate the effect of potential determinants and the effect of the programming.

    Measured: 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).

  10. Community walkability as perceived by participants

    The Physical Activity Neighborhood Environment Survey (PANES) provides estimates of self- reported neighbourhood, built environment supportiveness for physical activity with some degree of test-retest reliability and construct validity. The overall PANES score should have a range of 0 to 6, with higher values indicating greater environmental support for physical activity. For each item the investigators also have a dichotomized outcome to indicate whether strongly or somewhat agree with the statement. The mean and standard deviation will be presented for the overall PANES score and percentage of participants with strongly or somewhat agree with the statement in each item. Correlations of walkability index to physical activity and fitness (and changes within these categories) will be made. Indices will be compared between sites.

    Measured: 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).

  11. Participant quality of life, sense of belonging and mental health - Secondary

    Social well-being will be evaluated using Canadian Health Measures Survey (CHMS) sense of belonging question: GEN_Q18: How would you describe your sense of belonging to your local community? Would you say it is?

    1. Very strong
    2. Somewhat strong
    3. Somewhat weak
    4. Very weak

    Percentage of participants in each category pre and post program will be compared and correlated with other outcome measures such as attendance, BMI, percent body fat, etc. Chi-square tests will be used to identify whether the programming will significantly change the participants' sense of belonging to their local community. Generalized linear mixed model will also be used for the repeated measurements collected pre and post program considering other potential factors such as age, income, medical history, location, education level and so on.

    Measured: 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).

  12. Participant Nutrition - Healthy Eating Index

    The Healthy Eating Index (HEI) uses a scoring system to evaluate a set of foods. The score ranges from 0 to 100 points. The total HEI score is an indication of overall diet quality and changes in the HEI score will be used to determine whether dietary practices have improved throughout the intervention.

    Component scores when examined together show a pattern of diet quality. The summary statistics including the mean and standard deviation for the overall HEI and each component, will be included and the index value will be used as covariates when evaluating the changes in outcomes such as weight, BMI (kg/m2), PAM. Etc.

    Measured: 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).

  13. Participant Nutrition - Traditional Foods

    Individual questions adapted to address Indigenous population consumption of traditional foods and changes within this category.

    Measured: 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.

  14. Participant Nutrition - Health Education

    Nutrition knowledge: Questions developed based on the Health Education Modules with a focus on nutrition elements. Questions: Do you understand how to 'balance your diet'? Have you learned new recipes, methods of cooking, or methods for storage of food that will help you plan your meals (follow by 'give examples please')? Do you understand the difference between proteins, fats and carbohydrates and foods that provide these nutrients? Health knowledge is assessed at the end of the program and one year later to determine changes to knowledge over time.

    Measured: 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).

  15. Participant Nutrition - Food Security

    Food security will be evaluated using the 2-Item Food Security Screen. Percentage positively responding to food security questions and change over time will be completed and correlated with other outcome measures including nutritional intake, anthropometric changes, mental health and quality of life.

    Measured: 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).

  16. Awareness and access to previously unused or unknown resources

    Open-ended (qualitative) survey questions will assess if there are resources (ie. medical, mental health, cultural programming, recreational, food, social, etc.) that the participant faces barriers to accessing and whether their use of these resources changes with their participation in the program.

    This information will be reported in a table and will be provided to communities after the project is complete.

    Measured: 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).

  17. Attendance

    The investigators will present attendance rates as # participants/program, # attending <25%, 25- 50%, 50-75% and >75% of classes (mean attendance with range), a participant is defined as attending a program if they attended 50% or greater of the classes.

    Measured: Attendance is tracked throughout the program and ultimately evaluated at the end of the program (Week 18 or 24; Time 3).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start22 Nov 2021
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
1,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05362435
Sponsor's protocol ID
21-1305
Acronym
MKS+
Status last verified
Jan 2025
First submitted
22 Feb 2022
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bergman RN, Stefanovski D, Buchanan TA, Sumner AE, Reynolds JC, Sebring NG, Xiang AH, Watanabe RM. A better index of body adiposity. Obesity (Silver Spring). 2011 May;19(5):1083-9. doi: 10.1038/oby.2011.38. Epub 2011 Mar 3.

    PubMed 21372804

  • 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.

    PubMed 2043597

  • 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/

    PubMed 33347096

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Questions about this trial

What is this clinical trial studying?

A study testing Physical activity-based wellness programs in people with Physical Inactivity, run by University of Calgary at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sonja Wicklum, MD CCFP FCFP (403-955-9300, Sonja.wicklum@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05362435, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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