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Cardiovascular (CV) RiskFood is MedNCT07897838

Neqpiaput Iinruugut (Our Food Is Medicine): A Tribally Driven Food Sovereignty Intervention to Reduce Heart Disease Risk in Alaska Native Adults

A study testing Neqpiaput linruugut (Our Food is Medicine) in people with Cardiovascular (CV) Risk, run by University of Alaska Fairbanks at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study Neqpiaput Iinruugut ("Our Food is Medicine"), will test if a tribally designed Indigenous food sovereignty intervention can lower the risk of coronary heart disease in Alaska Native adults ages 18 to 65 years old. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular (CV) Risk
What is being tested?
Neqpiaput linruugut (Our Food is Medicine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
Oct 2026to Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age 18 to 65 years
  • Self identifies as Yup'ik
  • Not pregnant
  • Lives in one of the three communities

Who cannot join

  • Pregnant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Bersamin, PhD contact

907-474-6129

abersamin@alaska.edu

Maria Stejskal, BA contact

907-474-6230

mtrussell@alaska.edu

United States1 site
  • University of Alaska Fairbanks

    Fairbanks, Alaska, 99775

    Maria Stejskal, 907-474-6230, mtrussell@alaska.edu

Other trials in United States

About this study

Official title: Neqpiaput Iinruugut (Our Food is Medicine): Testing a Tribally-driven Intervention to Prevent Heart Disease Among Alaska Native Communities

This study Neqpiaput Iinruugut ("Our Food is Medicine"), will test if a tribally designed Indigenous food sovereignty intervention can lower the risk of coronary heart disease in Alaska Native adults ages 18 to 65 years old. Designed by Yup'ik Elders, the 12-month intervention combines Calricaraq, an established Elder-designed behavioral health program rooted in ancestral wisdom, with hands-on activities focused on traditional foodways. About 150 adults in three Alaska Native communities will take part. The main questions it aims to answer are:

  • Does the intervention lower participants' Framingham Risk Score, a measure of a person's chance of developing heart disease?
  • Do cultural strengths, such as cultural identity, Yup'ik wellness, community connectedness, social support, and family cohesion, grow with participation, and does that growth help explain changes in heart disease risk?
  • Does the intervention improve Indigenous food sovereignty, including practice and value of traditional foodways and the cultural systems that support them?
Read more

Researchers will compare communities receiving the intervention to communities waiting to start it (a dynamic wait-listed design) to see if the intervention lowers Framingham Risk Scores.

Participants will:

  • Attend monthly in-person Calricaraq gatherings in their community for 12 months
  • Attend quarterly hands-on food sovereignty workshops
  • Join a Facebook group that shares resources and supports engagement between in-person sessions
  • Have blood pressure and cholesterol measured and complete surveys during the study, including 6 months after the intervention ends
  • Be invited to take part in focus groups at 12 and 18 months
Read the detailed description

Neqpiaput Iinruugut (Our Food Is Our Medicine) is a culturally grounded, tribally designed intervention intended to reduce cardiovascular disease risk among Yup'ik adults by strengthening food sovereignty and cultural protective factors. The intervention is grounded in an Indigenist stress-coping framework that recognizes historical and ongoing stressors as contributors to cardiovascular disease risk and cultural identity, relationships, traditional food systems, and other cultural resources as potential protective factors.

Colonization disrupted Yup'ik cultural and traditional food systems, contributing to historical trauma, chronic stress, and reduced access to traditional foods. These changes may influence cardiovascular health through multiple pathways, including psychosocial stress and changes in diet. Neqpiaput Iinruugut takes a strengths-based approach that builds on Yup'ik knowledge, values, relationships, and traditional food practices to address these pathways.

The study will evaluate Neqpiaput Iinruugut among Yup'ik adults in three rural Alaska Native communities in the Yukon-Kuskokwim Delta. Communities are randomly assigned to the order in which they begin the intervention, with intervention start dates staggered by 12 months. All three communities receive the 12-month intervention.

Neqpiaput Iinruugut is delivered in each community by local interventionists and Elders with support from research staff and includes three components: (1) Calricaraq, a Yup'ik program for healing from historical trauma and reconnecting with cultural identity, delivered as an initial 3-day gathering followed by monthly 2- to 3-hour talking and learning circles (12 modules total); (2) quarterly Indigenous food sovereignty workshops at months 3, 6, 9, and 12 that include Elder stories, talking circles, hands-on subsistence activities, subsistence resources, and a shared traditional meal; and (3) a private, moderated community Facebook group that shares Elder teachings and reinforces concepts from the Calricaraq gatherings and food sovereignty workshops.

The primary goal of the study is to determine whether participation in Neqpiaput Iinruugut reduces estimated cardiovascular disease risk. The study will also examine hypothesized pathways of change, including perceived stress and responses to historical loss; cultural protective factors including Yup'ik wellness, cultural identity, connectedness, and family relationships; and food-related factors including traditional food consumption and Indigenous food sovereignty. Traditional food intake will also be assessed using stable isotope biomarkers measured from dried blood spot samples collected by finger stick. Participants are assessed during the 12-month intervention and six months after the intervention ends to examine both intervention-related change and maintenance of changes.

Being tested
Neqpiaput linruugut (Our Food is Medicine)
Keywords
AN Health and well-being, Community-based Participatory Research, Framingham Risk Score, Traditional Foods, Yup'ik

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neqpiaput linruugut (Our Food is Medicine)Behavioural

    Neqpiaput Inruugut is a 12-month, tribally designed intervention delivered in each community by local interventionists and Elders with support from research staff. It has three components: (1) Calricaraq, a Yup'ik program for healing from historical trauma and reconnecting with cultural identity, delivered as an initial 3-day gathering followed by monthly 2 to 3 hour talking and learning circles (12 modules in total); (2) quarterly Indigenous food sovereignty workshops at months 3, 6, 9, and 12, each with Elder stories, talking circles, hands-on subsistence activities, subsistence resources, and a shared traditional meal; and (3) a private, moderated community Facebook group that shares Elder teachings and reinforces concepts from the gatherings and workshops.

Study groups in NCT07897838
Study groupRoleWhat they receive
Neqpiaput Iinruugut (Our Food Is Our Medicine)ExperimentalParticipants in all three communities will receive the 12-month Neqpiaput Iinruugut intervention. Communities will be randomly assigned to the order in which they begin the intervention, with intervention start dates staggered by 12 months
Receives: Behavioral: Neqpiaput linruugut (Our Food is Medicine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Framingham Risk Score

    Estimated 10-year risk of coronary heart disease, using the Framingham Risk Score based on age, sex, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, and smoking status. Total and HDL cholesterol are measured from a fasting finger-stick blood sample using a Cholestech LDX point-of-care analyzer, and blood pressure is measured using an OMRON IntelliSense professional digital monitor. Remaining inputs are self-reported on the Demographic and Medical History Questionnaire. Higher scores indicate greater estimated 10-year cardiovascular disease risk.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

Secondary outcomes (11)
  1. Change in perceived stress

    Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), which measures the degree to which participants perceive situations in their lives as stressful, including feelings of overload and lack of control. Higher scores indicate greater perceived stress.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  2. Change in historical loss-associated symptoms

    Historical loss-associated symptoms will be assessed using an adapted Historical Loss Associated Symptoms Scale (HLASS), which measures emotional and behavioral responses associated with thinking about historical losses, including grief, anger, shame, and feelings of loss. Higher scores indicate more frequent symptoms associated with historical loss.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  3. Change in Yup'ik wellness

    Assessed using the Yup'ik Wellness Questionnaire, which measures two dimensions of engagement with Yup'ik cultural systems: frequency of participation in cultural practices and the importance participants place on those practices. Higher frequency ratings indicate more frequent engagement, and higher importance ratings indicate greater importance placed on the activity.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  4. Change in Yup'ik cultural identity

    Cultural identity will be assessed using one item measuring the degree to which participants identify with Yup'ik way of life. Higher ratings indicate greater identification with/following of a Yup'ik way of life.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  5. Change in Kass'aq (non-Native) cultural identity

    Cultural identity will be assessed using one item measuring the degree to which participants identify with Kass'aq way of life. Higher ratings indicate greater identification with/following of a Kass'aq way of life.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  6. Change in connectedness

    Connectedness will be assessed using the Awareness of Connectedness scale, which assesses reciprocity and connectedness to family, community, and land. Higher scores indicate greater awareness of connectedness.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  7. Change in family relationship

    Family relationships are assessed using 16 items from the Brief Family Relationship Scale (BFRS) addressing family support and cohesion, communication and expressiveness, and conflict. Higher scores indicate greater cohesion and lower conflict.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  8. Change in traditional food consumption

    Traditional food consumption will be assessed using a six-item survey measuring frequency of consumption across six traditional food categories: fish, marine mammals, land mammals, wild birds or eggs, berries, and wild plants or greens. Higher responses indicate more frequent traditional food consumption.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  9. Change in Indigenous food sovereignty

    Indigenous food sovereignty is assessed using 19 items addressing subsistence knowledge and skills, teaching and learning, food sharing, relationships, access, adaptability, stewardship, and impacts of colonization and changes in traditional food systems.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  10. Change in well-being

    Well-being is assessed using 14 item Warwick-Edinburgh Mental Well-being Scale (WEMWBS) addressing positive mental well-being during the previous two weeks, including optimism, feeling useful, relaxation, energy, coping, clear thinking, positive self-regard, connection with others, confidence, and feeling loved. Higher scores indicate greater positive mental well-being.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

  11. Change in stable isotope biomarker of traditional food intake

    Stable isotope ratios are measured from dried blood spot samples collected by finger stick as objective biomarkers of traditional food intake.

    Measured: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMar 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
This study will use a dynamic wait-listed design with 150 Yup'ik adults aged 18 to 65 years in three Alaska Native communities in the Yukon-Kuskokwim Delta. Intervention start dates will be staggered across communities by 12 months, allowing all participants to receive the 12-month Neqpiaput Iinruugut intervention. Outcomes will be assessed at baseline, 6 months (intervention midpoint), 12 months (end of intervention), and 18 months (6 months post-intervention).
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07897838
Sponsor's protocol ID
2447828
Other IDs
1R01HL181633-01
Acronym
Food is Med
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Walters KL, Simoni JM. Reconceptualizing native women's health: an "indigenist" stress-coping model. Am J Public Health. 2002 Apr;92(4):520-4. doi: 10.2105/ajph.92.4.520.

    PubMed 11919043
  • Allen J, Wexler L, Rasmus S. Protective Factors as a Unifying Framework for Strength-Based Intervention and Culturally Responsive American Indian and Alaska Native Suicide Prevention. Prev Sci. 2022 Jan;23(1):59-72. doi: 10.1007/s11121-021-01265-0. Epub 2021 Jun 24.

    PubMed 34169406
  • Bersamin A, Izumi BT, Nu J, O'brien DM, Paschall M. Strengthening adolescents' connection to their traditional food system improves diet quality in remote Alaska Native communities: results from the Neqa Elicarvigmun Pilot Study. Transl Behav Med. 2019 Oct 1;9(5):952-961. doi: 10.1093/tbm/ibz087.

    PubMed 31570921
  • Walters KL, Johnson-Jennings M, Stroud S, Rasmus S, Charles B, John S, Allen J, Kaholokula JK, Look MA, de Silva M, Lowe J, Baldwin JA, Lawrence G, Brooks J, Noonan CW, Belcourt A, Quintana E, Semmens EO, Boulafentis J. Growing from Our Roots: Strategies for Developing Culturally Grounded Health Promotion Interventions in American Indian, Alaska Native, and Native Hawaiian Communities. Prev Sci. 2020 Jan;21(Suppl 1):54-64. doi: 10.1007/s11121-018-0952-z.

    PubMed 30397737
  • Wolsko C, Lardon C, Hopkins S, Ruppert E. Conceptions of wellness among the Yup'ik of the Yukon-Kuskokwim Delta: the vitality of social and natural connection. Ethn Health. 2006 Nov;11(4):345-63. doi: 10.1080/13557850600824005.

    PubMed 17060033
  • Rivkin I, Lopez EDS, Trimble JE, Johnson S, Orr E, Quaintance T. Cultural values, coping, and hope in Yup'ik communities facing rapid cultural change. J Community Psychol. 2019 Apr;47(3):611-627. doi: 10.1002/jcop.22141. Epub 2018 Nov 8.

    PubMed 30407637
  • O'Brien DM, Kristal AR, Nash SH, Hopkins SE, Luick BR, Stanhope KL, Havel PJ, Boyer BB. A stable isotope biomarker of marine food intake captures associations between n-3 fatty acid intake and chronic disease risk in a Yup'ik study population, and detects new associations with blood pressure and adiponectin. J Nutr. 2014 May;144(5):706-13. doi: 10.3945/jn.113.189381. Epub 2014 Mar 5.

    PubMed 24598880

Questions about this trial

What is this clinical trial studying?

A study testing Neqpiaput linruugut (Our Food is Medicine) in people with Cardiovascular (CV) Risk, run by University of Alaska Fairbanks at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Bersamin, PhD (907-474-6129, abersamin@alaska.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Framingham Risk Score (time frame: Baseline (B), 6-month intervention midpoint (T1), 12-month end of intervention (T2), and 18-month follow-up (T3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07897838, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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