Qungasvik (Toolbox)-Healthy Hearts: A Cultural Approach to Reducing Chronic Disease Risk

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of Alaska Fairbanks

About this trial

Due to the extreme remoteness, transportation challenges, and lack of access to clinical care, the delivery of preventative health interventions in rural Alaska Native communities is a top tribal priority. Chronic disease and behavioral health contribute to the higher rates of mortality and morbidity experienced in rural Alaska. This study will test the effectiveness of a culturally-grounded, community-delivered preventive intervention, Qungasvik-Healthy Hearts, to reduce risk factors associated with chronic disease and behavioral health in three rural Alaska Native communities. Implementation science outcomes will identify key contextual factors, social determinants and costs associated with health outcomes related to positive change in behavior, blood pressure, diet and physical activity, assessed among 300 participants from the three rural communities.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

self-identify as a permanent resident of the study community

be a youth between the ages of 12-17 years, a young adult between the ages of 18-24, or an adult or elder the ages of 45+

be able to provide written informed consent.

Disqualifiers

does not have permanent residence in the community

is unable to provide written informed consent. All participant-facing study materials will be provided at an eighth-grade reading level.

Trial design

Design model

Single group

Treatments tested in this trial

  • Qungasvik-Healthy Hearts

    Behavioral

    Qungasvik-Healthy Hearts preventive intervention is a novel adaptation of an evidence-based practice that was developed by Yup'ik AN communities to address mental health and alcohol misuse. Qungasvik-Healthy Hearts explores the broader association between revitalizing physically laborious, socially connecting, and nutritionally rich traditional Yup'ik practices like hunting, gathering, and fishing, with cerebrovascular and cardiovascular disease risk reduction. A local Community Planning Group (CPG) facilitates activities tailored to directly address upstream cerebrovascular and cardiovascular disease risk factors, by supporting youth and older adults to increase intensity and duration of physical activity, facilitate social support and connection, and increase intake of traditional Yup'ik foods. These activities included modules such as Yuraq (traditional Yup'ik dance), moose hunting, ice fishing, and gathering (greens, eggs, etc.) on the land.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Implement Qungasvik-Healthy Hearts 12-month community-based preventive interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ActiGraph accelerometer data will measure the intensity of daily activity that we hypothesize will go up with intervention participation.

Physical activity will be objectively measured using an ActiGraph accelerometer, a validated wearable device that provides reliable estimates of free-living physical activity. Participants will wear the device for the prescribed monitoring period to capture movement continuously throughout daily activities. Accelerometer data will be processed using established protocols to estimate daily minutes of moderate-to-vigorous physical activity. Objective accelerometer data will complement self-reported measures of physical activity by reducing recall bias and providing precise estimates of changes in activity patterns over time.

Time frame
Day 1 Baseline(B) and 12-month follow-up (T2)
2

Traditional Food Intake

Traditional food intake will be assessed using both a self-reported dietary survey and hair nitrogen stable isotope ratio (¹⁵N/¹⁴N; δ¹⁵N) analysis. The dietary survey will capture the frequency and types of traditional foods consumed, providing information on dietary patterns and subsistence food practices. Hair samples will be collected to measure δ¹⁵N, a validated, objective biomarker of long-term traditional marine food intake among Alaska Native populations. Because hair integrates dietary intake over several months, δ¹⁵N provides a reliable estimate of sustained consumption of traditional subsistence foods, particularly marine fish and mammals, and is not subject to recall or social desirability bias. The combined use of self-reported dietary intake and the objective biomarker will strengthen the assessment of intervention-related changes in traditional food consumption by capturing both perceived dietary behaviors and biologically verified intake. These complementary measures

Time frame
Points of Assessment: Baseline(B) and 12-month follow-up (T2)
3

Blood Pressure

Blood pressure will be measured as an objective indicator of cardiovascular health and a key physiological outcome of the intervention. Systolic and diastolic blood pressure will be assessed using standardized protocols via Omron digital blood pressure monitor, including appropriate participant positioning, rest periods prior to measurement, and repeated readings to improve reliability. Primary outcomes will include changes in systolic blood pressure, diastolic blood pressure, and blood pressure categories over time. These measures will be used to evaluate whether participation in the intervention contributes to improvements in cardiovascular health through hypothesized pathways involving increased physical activity, improved dietary practices, reduced stress, and strengthened social and cultural connectedness.

Time frame
Points of Assessment: Baseline(B), 6-month intervention midpoint(T1), and 12-month follow-up (T2)
4

We will assess how intervention participation increases social and cultural connectedness using the Awareness of Connectedness Scale.

The Awareness of Connectedness Scale (ACS), developed by Mohatt and Fok, measures an individual's awareness of their interrelatedness with family, community, and the natural environment. This scale is particularly focused on cultural aspects of wellness and healing among Alaska Native people, providing insights into their social and ecological connections. We will utilize data from the scale to assess the intervention impacts on building connectedness among individual participants.

Time frame
Points of Assessment: Baseline(B), 6-month intervention midpoint(T1), and 12-month follow-up (T2)

Secondary outcomes

1

Food Security

Validated behavioral survey measure: NIH PROMIS

Time frame
Points of Assessment: Baseline(B), 6-month intervention midpoint(T1), and 12-month follow-up (T2)
2

Reasons for Life

Validated behavioral survey measure for mental health

Time frame
Points of Assessment: Baseline(B), 6-month intervention midpoint(T1), and 12-month follow-up (T2)
3

Global Health

Validated behavioral survey measure PhenX Toolkit

Time frame
Points of Assessment: Baseline(B), 6-month intervention midpoint(T1), and 12-month follow-up (T2)
4

We will assess if food security increases using the food security index from the PhenX Toolkit

The PhenX Toolkit includes standardized measures for assessing food security, which is crucial for understanding social determinants of health. We will use items from the standardized food security tools to evaluate how food access impacts health outcomes and if food security increases with individual participation in the intervention.

Time frame
Day 1 Baseline, 6 months, 12 months

Other outcomes

Sponsors and contacts

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