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

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 12 years and older
• All sexes
• Healthy volunteers accepted
• Child, Adult, Older adult

Trial locations and contacts

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

About this study

Official title: Qungasvik (Toolbox)-Healthy Hearts: An Alaska Enrichment Initiative (AK Enrichment)

Conditions

Cardio Vascular Disease, Cerebro Vascular Disease, Mental Health, Chronic Disease (Physical)

Being tested

Qungasvik-Healthy Hearts

Keywords

American Indian/Alaska Native, Native American, Alaska, Rural health, chronic disease prevention, cardiovascular disease, food security, mental health, physical activity, nutrition, hypertension, community-engagement, cultural measures, culture and health

Medical subject headings

Psychological Well-Being, Chronic Disease, Cardiovascular Diseases, Motor Activity, Hypertension

What participants receive

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

• Qungasvik-Healthy HeartsBehavioural

  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.

What is being measured

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

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.

   Measured: 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

   Measured: 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.

   Measured: 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.

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

5. ActiGraph accelerometer data will measure the frequency 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 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.

   Measured: Day 1 Baseline, 12 months

6. ActiGraph accelerometer data will measure the duration of daily activity including time spent in sedentary, light, moderate, and vigorous activity.

   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 sedentary time and step counts. 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.

   Measured: Day 1 Baseline, 12 months post follow-up

7. We will assess how the intervention increases individual protective factors using the Multi-Cultural Mastery Scale

   The Multicultural Mastery Scale, developed by Allen and Mohatt, assesses coping strategies through self-mastery and communal mastery dimensions. It includes subscales that differentiate between mastery related to family and friends, highlighting the importance of social networks. We will utilize data from this scale to determine how the intervention increases positive coping and builds social networks connections in individuals who participate.

   Measured: Day 1 Baseline, 6 months, 12 months

8. We will assess how the intervention increases reasons for life and meaning and purpose using the Reasons for Life Scale

   The Reasons for Life Scale (RFL), developed by Allen and Rasmus, focuses on cultural strengths and protective factors against suicide, particularly among Alaska Native people. It emphasizes resilience, cultural teachings, and community recognition as vital components in promoting mental health and preventing suicide. We will utilize data from scale to assess how the intervention promotes reasons for life and associates with mental health outcomes (depression and anxiety) in individuals who participate in activities.

   Measured: Day 1 baseline, 6 months, 12 months

9. We will assess social support using the Multidimensional Scale of Perceived Social Support (MSPSS).

   The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item questionnaire to identify an individual's perceived level of social support with family, friends, and significant others.

   Measured: Day 1, 6 months, 12 months

10. We will assess social connection through a self-report measure of intergenerational interaction and social engagement that we hypothesize will increase with intervention participation.

    This self-report measure is generated by an Alaska Native community advisory board and is tailored to a rural Alaska Native community including items assessing interaction with Elders and engagement in community gatherings.

    Measured: Day 1, 6 months, 12 months

Timeline

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

1. First posted21 Sep 2026
2. Study startOct 2026 (estimated)
3. Primary completionDec 2028 (estimated)
4. Study completionJan 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (4)Papers the sponsor has linked to this study.
• Other trials for Cardio Vascular DiseaseStudies 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.