Health Education Program for Sedentary Lifestyle

(MKS+ Trial)

Recruiting at 6 trial locations

Overseen By Carly Checholik, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Pregnancy, breastfeeding

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

1250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Indigenous women improve their health through a program that combines physical activity-based wellness, health education, and cultural engagement. Participants will join a 12-week program focusing on fitness, nutrition, and community support, followed by a 12-week follow-up. The goal is to enhance overall well-being, including mental health and improved lifestyle habits. Indigenous women from specific communities in Alberta and Saskatchewan who are 18 years or older can join. As an unphased trial, this study offers a unique opportunity for participants to engage in culturally tailored wellness programs that can lead to improved health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this health education program is safe?

Research has shown that the Makoyoh'sokoi (Wolf Trail Program) is generally safe for participants. Designed for Indigenous women, the program focuses on physical activity and wellness. In past studies, participants engaged in exercise and health education without any reports of serious issues. The program fosters a supportive community environment, enabling participants to join activities safely. By incorporating Indigenous practices, it remains culturally relevant and safe. Overall, the wellness program is well-received and aims to improve health in a manageable and supportive manner. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Makoyoh'sokoi (The Wolf Trail Program) because it takes a holistic approach to tackle sedentary lifestyles, which is unlike most standard treatments that often focus solely on increasing physical activity. This program uniquely combines physical exercise with health education and a sharing circle, offering a supportive community element that can enhance motivation and adherence. This comprehensive method not only promotes physical wellness but also addresses mental and emotional health, providing a more rounded pathway to a healthier lifestyle.

What evidence suggests that this program is effective for improving health in a sedentary lifestyle?

Research has shown that the Makoyoh'sokoi (The Wolf Trail Program), which participants in this trial will engage in, helps people become more active and healthier overall. Studies have found that those who join this program experience better fitness, improved body shape, and healthier heart and metabolism. Participants also report feeling better mentally and enjoying a higher quality of life. The program builds strong support networks and teaches about healthy living, making it easier to understand its importance. It is particularly helpful because it includes cultural and spiritual aspects, which can increase self-esteem and strengthen community ties. This well-rounded approach has shown promise in helping Indigenous women improve their health and wellbeing. ^{1 4 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

University of Calgary

Sonja Wicklum, MD CCFP FCFP

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

The Wolf Trail Program is for Indigenous women over 18 from specific communities in Alberta and Saskatchewan. It's open to those identifying as Métis, First Nations, or Inuit, including cis-female, binary, trans-females, queer and two-spirited individuals. Pregnant or breastfeeding women cannot participate.

Inclusion Criteria

Indigenous women may identify as Métis, First Nations or Inuit, living both on- and off-reserve

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

I identify as a woman, including cis, trans, binary, queer, or two-spirited.

Exclusion Criteria

Pregnancy and breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Live Program

Participants engage weekly in physical activity, health education modules, and sharing circles

12 weeks

12 visits (in-person)

Follow-up Program

Participants meet bi-weekly for health education modules and sharing circles

12 weeks

6 visits (in-person)

Long-term Follow-up

Participants are monitored for sustained health improvements and engagement with community resources

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity-based wellness programs

Trial Overview This program tests a wellness approach combining physical activity with health education on nutrition and prevention. Participants will also connect with local healthcare providers and Indigenous cultural elements to improve overall health literacy and self-management skills.

How Is the Trial Designed?

Group I: Participation in Makoyoh'sokoi (the Wolf Trail Program) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Published Research Related to This Trial

An educational program focused on physical activity significantly improved habitual physical activity levels and self-efficacy in patients after their first percutaneous coronary intervention, compared to usual care, in a study involving 109 participants.

The program's effectiveness was measured 5 to 7 months post-discharge, showing a mean score increase of 0.89 for physical activity and 2.30 for self-efficacy, with no significant differences in anxiety and depression symptoms between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an educational program on physical activity in individuals undergoing their first percutaneous coronary intervention: A randomized clinical trial. Pitta, NC., Furuya, RK., Freitas, NO., et al.[2023]

In a study of 3867 Norwegian adults aged 20-85, it was found that both men and women have similar overall physical activity levels, but men engage in more sedentary and moderate-to-vigorous physical activity compared to women.

The majority of participants (62%) spent their time being sedentary, with only 20% meeting national physical activity recommendations, indicating a significant need for increased physical activity among adults and older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerometer-determined physical activity in adults and older people. Hansen, BH., Kolle, E., Dyrstad, SM., et al.[2022]

In a study involving 25 sedentary older adults, health contracts significantly increased exercise adherence, with 20 participants achieving at least 75% of their exercise goals and 15 reaching 100%.

Participants found various components of the health contracts, such as motivation, goal setting, and social support, to be helpful in meeting their exercise objectives, suggesting that these strategies can be effectively used by health educators to promote physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health contract with sedentary older adults. Haber, D., Rhodes, D.[2019]

An educational intervention consisting of two workshops significantly improved self-efficacy and counseling frequency among 21 internal medicine residents compared to 27 control residents.

Despite the improvement in physicians' confidence and counseling behaviors, there was no significant increase in physical activity levels reported by patients, indicating that further strategies are needed to address barriers to exercise in chronically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing physician practice of physical activity counseling. Eckstrom, E., Hickam, DH., Lessler, DS., et al.[2023]

A study involving 171 community residents with metabolic syndrome showed that a 5-month initiation health program significantly improved lifestyle and laboratory test results, with benefits sustained over a 2-year follow-up.

Both the initiation program and a subsequent 6-month enhancing program led to similar improvements, indicating that even the shorter program was effective in promoting healthier lifestyles among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention study to promote self-improvement of lifestyle in a Japanese community: a new health support program. Fukumoto, K., Wei, CN., Matsuo, H., et al.[2021]

In a pilot study involving 6 older adults with type 2 diabetes, a 10-week health promotion program combining exercise, nutrition, and education showed promising improvements in glycemic control (A1C) and self-efficacy, indicating potential benefits for diabetes management.

Despite challenges in recruiting and retaining participants, those who completed the program reported high satisfaction and adherence, suggesting that such interventions could be effective if recruitment strategies are improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Kluding, PM., Singh, R., Goetz, J., et al.[2022]

A 24-week behavioral modification program using pedometers and telephone support significantly increased physical activity by an average of 2744 steps per day and reduced sedentary behavior by 23 minutes per day in type 2 diabetes patients.

These positive changes in physical activity and reduced sedentary time were still evident one year later, with an increase of 1872 steps per day and a decrease of 12 minutes in sedentary behavior, demonstrating the program's lasting impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a pedometer-based behavioral modification program with telephone support on physical activity and sedentary behavior in type 2 diabetes patients. De Greef, KP., Deforche, BI., Ruige, JB., et al.[2022]

Regular physical activity is proven to improve health, yet over half of the population in countries like Canada, Finland, the USA, and the former German Democratic Republic remains inactive during leisure time.

To effectively promote physical activity, national programs should combine educational and environmental strategies, and ongoing research is necessary to identify the best methods for encouraging regular exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dimensions of health promotion applied to physical activity. Powell, KE., Kreuter, MW., Stephens, T., et al.[2004]

In a study involving 21 COPD patients, those who received lifestyle physical activity counseling and used a pedometer increased their daily steps by 1,430 steps/day (69% increase), compared to a 455 steps/day (19% increase) in the control group, suggesting that the intervention may enhance physical activity levels.

While the primary outcome of increased daily steps was significant, secondary outcomes such as physical fitness and quality of life did not show notable differences, indicating that while the intervention is effective for increasing activity, it may not directly improve other health metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. de Blok, BM., de Greef, MH., ten Hacken, NH., et al.[2012]

Regular physical activity is crucial for health, with significant benefits seen even in those who are least physically fit; the greatest health gains occur with increased activity levels, particularly for those who have been inactive.

A minimum target of moderate-intensity activity, such as a daily 30-minute walk (approximately 150 kcal energy expenditure), is recommended to achieve substantial health improvements, and this can be broken into shorter intervals throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physical activity and health--recommendations]. Anderssen, SA., Strømme, SB.[2008]

The Novartis Cardio Metabolic Program significantly improved blood pressure control among participants, increasing from 38% at baseline to 79% after 6 months, indicating effective management of hypertension.

Participants also showed improved control of low-density lipoprotein cholesterol, rising from 22% to 34%, and a significant decrease in body mass index, highlighting the program's positive impact on cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A health outcome assessment of the Cardio Metabolic Mission Health Program at Novartis. Mauceri, E., Bienkowski, C., Hanson, KA., et al.[2019]

The Prince Edward Island-First Step Program (PEI-FSP) successfully increased daily steps from an average of 7,029 to 10,480 over a 12-week period among 106 sedentary workers, demonstrating its efficacy in promoting physical activity.

Participants experienced significant health improvements, including reductions in body mass index (BMI), waist girth, and resting heart rate, with these reductions being linked to increased daily steps, regardless of their initial BMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of a pedometer-based physical activity intervention in sedentary workers. Chan, CB., Ryan, DA., Tudor-Locke, C.[2006]

A study involving 24 high-risk workers in a wellness program identified key barriers to physical activity, including physical limitations, lack of motivation, and time constraints.

Family relationships and social support were found to be the strongest motivators for these workers, emphasizing the need for tailored interventions that address their specific challenges and leverage their support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity barriers and motivators among high-risk employees. Paguntalan, JC., Gregoski, M.[2017]

There is a significant lack of formal physical activity programs in medical care settings, despite the potential for these encounters to encourage patients to increase their activity levels.

Community campaigns can raise awareness and interest in physical activity, but they have limited short-term impact on actual behavior changes, highlighting a missed opportunity in schools where physical education classes do not effectively improve children's fitness or promote lifelong activity skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promotion of physical activity in the United States population: the status of programs in medical, worksite, community, and school settings. Iverson, DC., Fielding, JE., Crow, RS., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10422705/

Spread of Makoyoh'sokoi (Wolf Trail) - PubMed Central - NIH The effectiveness of the Makoyoh'sokoi program in improving objective measures of physical activity, health status and patient-reported ...

2. withpower.com withpower.com/trial/phase-physical-inactivity-10-2021-fff4d

Health Education Program for Sedentary Lifestyle For example, a study on diabetes patients found that a program using pedometers and phone support increased physical activity and reduced sedentary behavior.

3. researchgate.net researchgate.net/publication/373096377_Spread_of_Makoyoh'sokoi_Wolf_Trail_a_community_led_physical_activity-based_holistic_wellness_program_for_Indigenous_women_in_Canada

(PDF) Spread of Makoyoh'sokoi (Wolf Trail): a community ... Makoyoh'sokoi's core program consists of 12 weeks of weekly physical activity ... physical activity, health. status and patient-reported outcomes ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05362435?keyword=%22Inactivity%22

Makoyoh'Sokoi - The Wolf Trail Program Expansion Project 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), ...

5. researchgate.net researchgate.net/publication/336946288_Results_of_a_culturally_relevant_physical_activity-based_wellness_program_for_urban_Indigenous_women_in_Alberta_Canada

(PDF) Results of a culturally relevant, physical activity- ... Makoyoh'sokoi (The Wolf Trail Program) is an 18-week long, holistic wellness program that was created by and for Indigenous women. Makoyoh'sokoi was ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05362435/makoyohsokoi-the-wolf-trail-program-expansion-project-supporting-indigenous-women-to-celebrate-good-health

Makoyoh'Sokoi - The Wolf Trail Program Expansion Project 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 ...

7. wolftrail.ca wolftrail.ca/faq/

FAQs - Makoyoh'Sokoi - The Wolf Trail Wellness Program MKS is a free wholistic physical activity-based wellness program for Indigenous women, guided by Indigenous practices and traditions, and facilitated by ...

8. wolftrail.ca wolftrail.ca/program-information/

Program Information The goal of MKS+ is for participants to develop a community of support and safely engage in physical activity and learning.