Clinical trial NCT07014852: Integrating Inuit Knowledge Principles in Multi-Level Mental Health Clinical Trials
Official title: Integrating Inuit Knowledge Principles in Multi-Level Mental Health Clinical Trials
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Depression, Anxiety
Keywords: Inuit
Country Foods
mental health
depression
anxiety
food sovereignty
cultural identity
community wellness
Indigenous health
Inuit Qaujimajatuqangit (IQ)
social cohesion
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Aqqiumavvik - Arviat Wellness Society
First posted: 2025-06-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cultural Acceptability of the Intervention- Qualitative Interviews
timeFrame: From enrolment to the end of treatment at 12 weeks
measure: Cultural Acceptability of the Intervention- Participant Diaries
timeFrame: From enrolment to the end of treatment at 12 weeks
measure: Participant satisfaction and perceived impact on mental health
timeFrame: From enrolment to the end of treatment at weeks 4, 8, and 12.
measure: Mental Health Impacts
timeFrame: Baseline (enrolment)
measure: Mental Health Impacts - 4 weeks
timeFrame: 4 weeks after enrolment
measure: Mental Health Impacts
timeFrame: 8 weeks after enrolment
measure: Mental Health Impacts
timeFrame: 12 weeks after enrolment
measure: Participant Satisfaction- Participant Diaries
timeFrame: Baseline (at enrolment)
measure: Participant Satisfaction- Participant Diaries
timeFrame: 4 weeks after enrolment
measure: Participant Satisfaction- Participant Diaries
timeFrame: 8 weeks after enrolment
measure: Participant Satisfaction- Participant Diaries
timeFrame: 12 weeks after enrolment
Secondary outcomes:
measure: Assessment of the Role of Elders in Transferring Cultural Knowledge- Workshops
timeFrame: 12 weeks after enrolment
measure: Assessment of the Role of Elders in Transferring Cultural Knowledge- Conversations
timeFrame: 12 weeks after enrolment
measure: Systemic Barriers to Accessing Country Food- Interviews
timeFrame: 12 weeks after enrolment
measure: Systemic Barriers to Accessing Country Food- Participant Diaries
timeFrame: 12 weeks after enrolment
measure: Systemic Barriers to Accessing Country Food- Discussions
timeFrame: 12 weeks after enrolment
measure: Integration of IQ principles into clinical systems- Participant Diaries
timeFrame: Once between 12-24 weeks after enrolment
measure: Integration of IQ principles into clinical systems- Discussions
timeFrame: Once between 12-24 weeks after enrolment
measure: Integration of IQ principles into clinical systems- Interviews
timeFrame: Once between 12-24 weeks after enrolment
Other outcomes:
Locations:
city: Arviat
country: Canada
facility: Aqqiumavvik Society
state: Nunavut
city: Arviat
country: Canada
facility: Aqqiumavvik - Arviat Wellness Society
state: Nunavut
Study officials:
affiliation: University of Alberta
name: Wayne Clark, Ed.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Justin Ezekowitz, MD
role: PRINCIPAL_INVESTIGATOR
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