Меню
Идёт набор NCT05362435

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

Без фазы С лечением Physical Inactivity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Physical activity-based wellness programs.
Кому может быть актуально
Состояния в реестре: Physical Inactivity. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Activation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]
Вторичные конечные точки (12)
  • Participant cardiometabolic health - Metabolic Syndrome [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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).]
  • Participant anthropometrics [Срок оценки: 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).]
  • Fitness - Grip Strength [Срок оценки: 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).]
  • Fitness - 1-mile walk test [Срок оценки: 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).]
  • Participant quality of life, sense of belonging and mental health [Срок оценки: 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).]
  • Community walkability as perceived by participants [Срок оценки: 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).]
  • Participant quality of life, sense of belonging and mental health - Secondary [Срок оценки: 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).]
  • Participant Nutrition - Healthy Eating Index [Срок оценки: 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).]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Pregnancy and breastfeeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Канада · 7 центров
  • Miskanawah — Calgary
  • Edmonton — Edmonton
  • Piikani First Nation — Piikani Nation
  • Flying Dust First Nation — Flying Dust First Nation
  • Ministikwan Lake Cree Nation — Ministikwan Lake
  • Onion Lake Health Centre — Onion Lake
  • Waterhen Lake First Nation — Waterhen Lake

Публикации

  • 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. PMID 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. PMID 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/ PMID 33347096
  • 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
  • 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
  • Halls, S.B. Body Fat Percentage: Find Out Yours. Halls.md. Body fat percentage formula from body mass index (halls.md). 2019.
  • 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
  • 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

Идентификаторы

NCT: NCT05362435 · 21-1305

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗