Depression, AnxietyEarly Phase 1NCT07014852
Integrating Inuit Knowledge Principles in Multi-Level Mental Health Clinical Trials
A Early Phase 1 study testing Traditional Country Foods and Cultural Workshops in people with Depression, Anxiety, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Traditional Country Foods and Cultural Workshops
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Oct 2025to 30 Sep 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Aqqiumavvik Society
Arviat, Nunavut, X0C 0E0
Aqqiumavvik - Arviat Wellness Society
Arviat, Nunavut, X0C0E0
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Traditional Country Foods, Cultural Workshops
- Keywords
- Inuit, Country Foods, mental health, depression, anxiety, food sovereignty, cultural identity, community wellness, Indigenous health, Inuit Qaujimajatuqangit (IQ), social cohesion
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Country FoodsOther
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 WorkshopsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Other | Weekly distributions of traditional country foods (caribou, seal, Arctic char), Elder-led workshops on food preparation and cultural practices, and mental health supports through unnikkaaratiginniq and sharing circles for the first 30 days of the trial. Receives: Other: Traditional Country Foods; Behavioral: Cultural Workshops |
| Delayed Intervention | Other | Participating in baseline assessments only (no guided conversations or workshops from Days 1-30). From Days 30-60, the delayed intervention group will receive the same intervention as the immediate intervention group Receives: Other: Traditional Country Foods; Behavioral: Cultural Workshops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cultural Acceptability of the Intervention- Qualitative Interviews
Qualitative interviews with healthcare providers and community facilitators will explore barriers and facilitators to intervention implementation.
Measured: From enrolment to the end of treatment at 12 weeks
Cultural Acceptability of the Intervention- Participant Diaries
Participant diaries will also be used to assess the perceived cultural significance of the intervention.
Measured: From enrolment to the end of treatment at 12 weeks
Participant satisfaction and perceived impact on mental health
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.
Measured: From enrolment to the end of treatment at weeks 4, 8, and 12.
Mental Health Impacts
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.
Measured: Baseline (enrolment)
Mental Health Impacts - 4 weeks
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
Measured: 4 weeks after enrolment
Mental Health Impacts
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.
Measured: 8 weeks after enrolment
Mental Health Impacts
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.
Measured: 12 weeks after enrolment
Participant Satisfaction- Participant Diaries
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.
Measured: Baseline (at enrolment)
Participant Satisfaction- Participant Diaries
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
Measured: 4 weeks after enrolment
Participant Satisfaction- Participant Diaries
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
Measured: 8 weeks after enrolment
Participant Satisfaction- Participant Diaries
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
Measured: 12 weeks after enrolment
Secondary outcomes (8)
Assessment of the Role of Elders in Transferring Cultural Knowledge- Workshops
Assessment of the Role of Elders in Transferring Cultural Knowledge will be evaluated through Elder-led workshops.
Measured: 12 weeks after enrolment
Assessment of the Role of Elders in Transferring Cultural Knowledge- Conversations
Assessment of the Role of Elders in Transferring Cultural Knowledge will be evaluated through guided unikkaaqatiginniq conversations.
Measured: 12 weeks after enrolment
Systemic Barriers to Accessing Country Food- Interviews
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.
Measured: 12 weeks after enrolment
Systemic Barriers to Accessing Country Food- Participant Diaries
Evaluation of systemic barriers to accessing country food will be done via qualitative analysis of participant diaries.
Measured: 12 weeks after enrolment
Systemic Barriers to Accessing Country Food- Discussions
Evaluation of systemic barriers to accessing country food will be done via insights from Circle discussions with participants.
Measured: 12 weeks after enrolment
Integration of IQ principles into clinical systems- Participant Diaries
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.
Measured: Once between 12-24 weeks after enrolment
Integration of IQ principles into clinical systems- Discussions
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.
Measured: Once between 12-24 weeks after enrolment
Integration of IQ principles into clinical systems- Interviews
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.
Measured: Once between 12-24 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Oct 2025
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Aqqiumavvik - Arviat Wellness Society
- Responsible party
- Sponsor
- Investigators
- Wayne Clark, Ed.D, Principal investigator, University of AlbertaJustin Ezekowitz, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014852
- Sponsor's protocol ID
- Pro00149001
- Status last verified
- Oct 2026
- First submitted
- 12 May 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the size of the study population, IPD will not be shared.
Publications
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.
PubMed 16042162Wilson, 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.
PubMed 22049381Santos 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
Richmond C, Elliott SJ, Matthews R, Elliott B. The political ecology of health: perceptions of environment, economy, health and well-being among 'Namgis First Nation. Health Place. 2005 Dec;11(4):349-65. doi: 10.1016/j.healthplace.2004.04.003.
PubMed 15886143Power EM. Conceptualizing food security or aboriginal people in Canada. Can J Public Health. 2008 Mar-Apr;99(2):95-7. doi: 10.1007/BF03405452.
PubMed 18457280Marmot M. Social justice, epidemiology and health inequalities. Eur J Epidemiol. 2017 Jul;32(7):537-546. doi: 10.1007/s10654-017-0286-3. Epub 2017 Aug 3.
PubMed 28776115Louis, R. P. (2007). Can you hear us now? Voices from the margin: Using Indigenous methodologies in geographic research. Geographical Research, 45(2), 130-139. https://doi.org/10.1111/j.1745-5871.2007.00443.x
LaLonde, C. E., Richmond, C. A., & McGregor, D. (2023). Food security, cultural continuity, and Indigenous health in Canada: The critical role of community initiatives. Canadian Journal of Public Health, 114(1), 45-54. https://doi.org/10.17269/s41997-022-00669-0
Kovach, M. (2009). Indigenous methodologies: Characteristics, conversations, and contexts. University of Toronto Press.
Kazdin, A. E. (2021). Research design in clinical psychology (5th ed.). Cambridge University Press.