Integrating Inuit Knowledge Principles in Multi-Level Mental Health Clinical Trials

Обзор

This study is looking at how eating more country foods affects mental health among Inuit men and women in Arviat, NU. The goal is to evaluate if eating more of these foods helps people feel less depressed or anxious, and whether being part of food-gathering and cultural activities also makes a difference. Whether the positive effects last over time, and if getting access to these foods later (instead of right away) still helps people feel better, will also be assessed.

Подробное описание

The primary objective of this study is to evaluate the feasibility, cultural acceptability, and potential mental health impacts, measured using PHQ-9 as part of a multi-level intervention (MLI) that integrates country foods, community wellness practices, and clinical care.

Specifically, the intervention aims to:

Improve mental health outcomes: Increased access to country foods is hypothesized to reduce depression and anxiety.

Strengthen cultural identity: Community-led wellness activities are expected to enhance cultural identity and community cohesion.

Enhance food sovereignty: Addressing systemic barriers can improve access to country foods and support culturally relevant healthcare.

Promote continuity of care: Integrating culturally grounded interventions into care plans can improve patient outcomes and overall wellness.

Secondary objectives include assessing the role of Elders in transferring cultural knowledge, identifying systemic barriers to accessing country food, and evaluating the integration of IQ principles into clinical systems. Elders are expected to facilitate social cohesion and transfer cultural knowledge, which are vital for community resilience. Policy recommendations will be explored to address systemic barriers, while the intervention's findings will inform clinical care plans to promote culturally relevant healthcare.

Ultimately, this research aims to develop community-based, culturally aligned solutions that promote resilience, improve health outcomes, and support Inuit self-determination. This study aims to create sustainable pathways for wellness and food sovereignty in Inuit communities by addressing historical injustices and systemic inequities.

Research Question(s): This study is guided by the following research questions:

How does increased access to country foods influence individual mental health outcomes, including anxiety, depression, emotional well-being, and resilience? How do community-driven food-gathering activities enhance social cohesion, cultural identity, and collective mental health within Inuit communities? What structural, systemic, and environmental barriers restrict access to Inuit country foods, and what specific policy interventions can effectively address these barriers to promote sustainable food security and mental health improvements? How do land-based and country food wellness programs integrate holistic approaches to address biological, psychological, social, and cultural determinants of mental health? What role do interdisciplinary collaborations and culturally relevant care practices play in improving access to country foods and fostering mental health equity in Inuit communities?

Hypotheses:

Increased access to country foods will improve mental health outcomes, including reduced depression and anxiety.

Community-led wellness activities will strengthen cultural identity, social bonds, and cohesion.

Access to country foods will help address systemic barriers and enhance food sovereignty while supporting culturally relevant healthcare.

Integrating culturally grounded interventions into care plans will improve continuity of care and patient outcomes.

Вмешательства

• Другое Traditional Country Foods
  Participants will receive weekly distributions of traditional foods, including caribou and fish. Guided conversations will explore changes in dietary habits, emotional well-being, and cultural connections
• Поведенческое Cultural Workshops
  Weekly workshops led by Elders will focus on traditional country food, food preparation, and sharing practices, enhancing cultural identity and community bonds. Participants will also engage in cultural camps where they will be led by Elders in land based teachings on country food.

Первичные конечные точки

• Cultural Acceptability of the Intervention- Qualitative Interviews [Срок оценки: From enrolment to the end of treatment at 12 weeks]
• Cultural Acceptability of the Intervention- Participant Diaries [Срок оценки: From enrolment to the end of treatment at 12 weeks]
• Participant satisfaction and perceived impact on mental health [Срок оценки: From enrolment to the end of treatment at weeks 4, 8, and 12.]
• Mental Health Impacts [Срок оценки: Baseline (enrolment)]
• Mental Health Impacts - 4 weeks [Срок оценки: 4 weeks after enrolment]
• Mental Health Impacts [Срок оценки: 8 weeks after enrolment]
• Mental Health Impacts [Срок оценки: 12 weeks after enrolment]
• Participant Satisfaction- Participant Diaries [Срок оценки: Baseline (at enrolment)]
• Participant Satisfaction- Participant Diaries [Срок оценки: 4 weeks after enrolment]
• Participant Satisfaction- Participant Diaries [Срок оценки: 8 weeks after enrolment]

Вторичные конечные точки (8)

• Assessment of the Role of Elders in Transferring Cultural Knowledge- Workshops [Срок оценки: 12 weeks after enrolment]
• Assessment of the Role of Elders in Transferring Cultural Knowledge- Conversations [Срок оценки: 12 weeks after enrolment]
• Systemic Barriers to Accessing Country Food- Interviews [Срок оценки: 12 weeks after enrolment]
• Systemic Barriers to Accessing Country Food- Participant Diaries [Срок оценки: 12 weeks after enrolment]
• Systemic Barriers to Accessing Country Food- Discussions [Срок оценки: 12 weeks after enrolment]
• Integration of IQ principles into clinical systems- Participant Diaries [Срок оценки: Once between 12-24 weeks after enrolment]
• Integration of IQ principles into clinical systems- Discussions [Срок оценки: Once between 12-24 weeks after enrolment]
• Integration of IQ principles into clinical systems- Interviews [Срок оценки: Once between 12-24 weeks after enrolment]

Критерии участия

Критерии включения

• Inuit
• Able to consent to study participation
• Participating in community wellness programs facilitated by the Aqqiumavvik Wellness Centre within 6 months prior to screening
• Willing to consume country foods provided as part of the intervention
• Willing to engage in individual and group activities, including guided conversations and cultural workshops
• 18-65 years of age

Критерии исключения

• Less than 18 years of age
• Greater than 65 years of age
• Unable to consent to study participation
• Mental health conditions requiring immediate clinical intervention
• Known allergies or medical conditions that prevent the consumption of traditional country foods
• Physical or logistical barriers that prevent participation in weekly activities

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Канада · 2 центра

• Aqqiumavvik Society — Arviat
• Aqqiumavvik - Arviat Wellness Society — Arviat

Публикации

• Young, T. K. (2012). Health and disease in the Canadian North. University of Toronto Press.
• Willows ND. Determinants of healthy eating in Aboriginal peoples in Canada: the current state of knowledge and research gaps. Can J Public Health. 2005 Jul-Aug;96 Suppl 3:S32-6, S36-41. English, French. PMID 16042162
• Wilson, S. (2008). Research is ceremony: Indigenous research methods. Fernwood Publishing.
• Turner, N. J., Ignace, M. B., & Ignace, R. (2013). Traditional ecological knowledge and wisdom of Aboriginal Peoples in British Columbia. Ecological Applications, 10(5), 1275-1287.
• Tagalik, S. (2011). Inuit Qaujimajatuqangit: The role of Indigenous knowledge in supporting wellness in Inuit communities. National Collaborating Centre for Aboriginal Health. https://www.nccih.ca/docs/context/FS-InuitQaujimajatuqangitWellness-EN.pdf
• Austin S. Decolonizing methodologies: research and indigenous people. J Health Psychol. 2001 May;6(3):358-9. doi: 10.1177/135910530100600310. No abstract available. PMID 22049381
• Santos Dunn, C., Yazzie, M., & Tsosie, R. (2023). Colonial legacies, food sovereignty, and health inequities among Indigenous peoples. Indigenous Policy Journal, 34(1), 1-18.
• Rink, E. (2019). Intergenerational trauma and resilience among Indigenous youth: A multi-level intervention model. Journal of Adolescent Health, 65(6), 782-789. https://doi.org/10.1016/j.jadohealth.2019.07.014

Идентификаторы

NCT: NCT07014852 · Pro00149001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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