Integrating Inuit Knowledge Principles in Multi-Level Mental Health Clinical Trials
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- University of Alberta
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Cultural Acceptability of the Intervention- Qualitative Interviews
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Immediate Intervention
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.
Intervention: Traditional Country Foods (Other)
Immediate Intervention
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.
Intervention: Cultural Workshops (Behavioral)
Delayed Intervention
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
Intervention: Traditional Country Foods (Other)
Delayed Intervention
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
Intervention: Cultural Workshops (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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
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
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.
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.
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.
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
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
Secondary Outcomes
- Integration of IQ principles into clinical systems- Participant Diaries(Once between 12-24 weeks after enrolment)
- Integration of IQ principles into clinical systems- Discussions(Once between 12-24 weeks after enrolment)
- Integration of IQ principles into clinical systems- Interviews(Once between 12-24 weeks after enrolment)
- Systemic Barriers to Accessing Country Food- Discussions(12 weeks after enrolment)
- Assessment of the Role of Elders in Transferring Cultural Knowledge- Workshops(12 weeks after enrolment)
- Systemic Barriers to Accessing Country Food- Interviews(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- Participant Diaries(12 weeks after enrolment)