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

NCT07014852 | Recruiting Early Phase 1 DMC

• 1 other identifier: Pro00149001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression, Anxiety

Keywords

Inuit; Country Foods; mental health; depression; anxiety; food sovereignty; cultural identity; community wellness; Indigenous health; Inuit Qaujimajatuqangit (IQ); social cohesion

Outcome Measures

Primary Outcomes (11)

• Cultural Acceptability of the Intervention- Qualitative Interviews

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

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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

  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

  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

  12 weeks after enrolment

Secondary Outcomes (8)

• Assessment of the Role of Elders in Transferring Cultural Knowledge- Workshops

  12 weeks after enrolment

• Assessment of the Role of Elders in Transferring Cultural Knowledge- Conversations

  12 weeks after enrolment

• Systemic Barriers to Accessing Country Food- Interviews

  12 weeks after enrolment

• Systemic Barriers to Accessing Country Food- Participant Diaries

  12 weeks after enrolment

• Systemic Barriers to Accessing Country Food- Discussions

  12 weeks after enrolment

Study Arms (2)

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.

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

Other: Traditional Country Foods; Behavioral: Cultural Workshops

Interventions

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

Delayed Intervention; Immediate Intervention

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.

Delayed Intervention; Immediate Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Aqqiumavvik - Arviat Wellness Society: collaborator

Study Sites (2)

Aqqiumavvik Society

Arviat, Nunavut, X0C 0E0, Canada

RECRUITING

Aqqiumavvik - Arviat Wellness Society

Arviat, Nunavut, X0C0E0, Canada

NOT YET RECRUITING

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MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Wayne Clark, Ed.D

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Justin Ezekowitz, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wayne Clark, Ed.D

CONTACT

7804928482; wclark1@ualberta.ca

Tibetha Kemble, PhD

CONTACT

5875902693; kemble@ualberta.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 11, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)