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NCT Number: NCT07014852

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Aqqiumavvik - Arviat Wellness Society, Arviat, Nunavut, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Country Foods

Other

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

Cultural Workshops

Behavioral

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.

Primary outcomes

  1. Cultural Acceptability of the Intervention- Qualitative Interviews

    Time frame: From enrolment to the end of treatment at 12 weeks

    Qualitative interviews with healthcare providers and community facilitators will explore barriers and facilitators to intervention implementation.

  2. Cultural Acceptability of the Intervention- Participant Diaries

    Time frame: From enrolment to the end of treatment at 12 weeks

    Participant diaries will also be used to assess the perceived cultural significance of the intervention.

  3. Participant satisfaction and perceived impact on mental health

    Time frame: From enrolment to the end of treatment at weeks 4, 8, and 12.

    Data will also be collected through participant diaries, focusing on experiences with country food consumption, the perceived cultural significance of the intervention, and overall satisfaction with the program. REDCap surveys will collect data from participant diaries, allowing for consistent monitoring of cultural experiences and satisfaction over time.

  4. Mental Health Impacts

    Time frame: Baseline (enrolment)

    Potential mental health impacts will be measured using the Patient Health Questionnaire-9 (PHQ-9) tool at baseline. Scoring ranges from 0-27; a higher score indicates worse mental health.

  5. Mental Health Impacts - 4 weeks

    Time frame: 4 weeks after enrolment

    Potential mental health impacts will be measured using the Patient Health Questionnaire-9 (PHQ-9) tool 4 weeks after enrolment. Scoring ranges from 0-27; a higher score indicates worse mental health

  6. Mental Health Impacts

    Time frame: 8 weeks after enrolment

    Potential mental health impacts will be measured using the Patient Health Questionnaire-9 (PHQ-9) tool 8 weeks after enrolment. Scoring ranges from 0-27; a higher score indicates worse mental health.

  7. Mental Health Impacts

    Time frame: 12 weeks after enrolment

    Potential mental health impacts will be measured using the Patient Health Questionnaire (PHQ-9) tool 12 weeks after enrolment. Scoring ranges from 0-27; a higher score indicates worse mental health.

  8. Participant Satisfaction- Participant Diaries

    Time frame: Baseline (at enrolment)

    Data will be collected through participant diaries that focus on experiences with country food consumption, the perceived cultural significance of the intervention, and overall satisfaction with the program at baseline.

  9. Participant Satisfaction- Participant Diaries

    Time frame: 4 weeks after enrolment

    Data will be collected through participant diaries that focus on experiences with country food consumption, the perceived cultural significance of the intervention, and overall satisfaction with the program 4 weeks after enrolment

  10. Participant Satisfaction- Participant Diaries

    Time frame: 8 weeks after enrolment

    Data will be collected through participant diaries that focus on experiences with country food consumption, the perceived cultural significance of the intervention, and overall satisfaction with the program 8 weeks after enrolment

  11. Participant Satisfaction- Participant Diaries

    Time frame: 12 weeks after enrolment

    Data will be collected through participant diaries that focus on experiences with country food consumption, the perceived cultural significance of the intervention, and overall satisfaction with the program 12 weeks after enrolment

Secondary outcomes

  1. Assessment of the Role of Elders in Transferring Cultural Knowledge- Workshops

    Time frame: 12 weeks after enrolment

    Assessment of the Role of Elders in Transferring Cultural Knowledge will be evaluated through Elder-led workshops.

  2. Assessment of the Role of Elders in Transferring Cultural Knowledge- Conversations

    Time frame: 12 weeks after enrolment

    Assessment of the Role of Elders in Transferring Cultural Knowledge will be evaluated through guided unikkaaqatiginniq conversations.

  3. Systemic Barriers to Accessing Country Food- Interviews

    Time frame: 12 weeks after enrolment

    Evaluation of systemic barriers to accessing country food will be done via interviews with health care providers who provide care to Inuit within the region.

  4. Systemic Barriers to Accessing Country Food- Participant Diaries

    Time frame: 12 weeks after enrolment

    Evaluation of systemic barriers to accessing country food will be done via qualitative analysis of participant diaries.

  5. Systemic Barriers to Accessing Country Food- Discussions

    Time frame: 12 weeks after enrolment

    Evaluation of systemic barriers to accessing country food will be done via insights from Circle discussions with participants.

  6. Integration of IQ principles into clinical systems- Participant Diaries

    Time frame: Once between 12-24 weeks after enrolment

    Evaluation of the integration of IQ principles into clinical systems will be done via qualitative analysis of participant diaries. Recommendations will be made to the Government of Nunavut and the Nunavut Health Authority based on this analysis into how IQ principles can be incorporated across the health care and clinical systems.

  7. Integration of IQ principles into clinical systems- Discussions

    Time frame: Once between 12-24 weeks after enrolment

    Evaluation of the integration of IQ principles into clinical systems will be done via insights from Circle discussions with participants. Recommendations will be made to the Government of Nunavut and the Nunavut Health Authority based on this analysis into how IQ principles can be incorporated across the health care and clinical systems.

  8. Integration of IQ principles into clinical systems- Interviews

    Time frame: Once between 12-24 weeks after enrolment

    Evaluation of the integration of IQ principles into clinical systems will be done via interviews with health care providers who provide care to Inuit within the region. Recommendations will be made to the Government of Nunavut and the Nunavut Health Authority based on this analysis into how IQ principles can be incorporated across the health care and clinical systems.

Study contacts

Contact information is provided by the study sponsor or research team.

Tibetha Kemble, PhD

CONTACT

[email protected]

5875902693

Wayne Clark, Ed.D

CONTACT

[email protected]

7804928482

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Aqqiumavvik - Arviat Wellness Society

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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