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

NCT07829341 | Not Yet Recruiting DMC

• 1 other identifier: 6922-07-AIAN/NHPI-S002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (10)

• 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.

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

• 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

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

• 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.

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

• 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.

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

• 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.

  Day 1 Baseline, 12 months

• 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.

  Day 1 Baseline, 12 months post follow-up

• 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.

  Day 1 Baseline, 6 months, 12 months

• 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.

  Day 1 baseline, 6 months, 12 months

• 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.

  Day 1, 6 months, 12 months

• 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.

  Day 1, 6 months, 12 months

Secondary Outcomes (5)

• Food Security

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

• Reasons for Life

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

• Global Health

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

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

  Day 1 Baseline, 6 months, 12 months

• We will assess how the intervention impacts physical activity by using a set of questions developed by our community partners to determine how people's physical activity behaviors might have changed with the intervention.

  Day 1, 6 months, 12 months

Study Arms (1)

Implement Qungasvik-Healthy Hearts 12-month community-based preventive intervention

EXPERIMENTAL

Implementation of Qungasvik-Healthy Hearts intervention over a 12-month period of delivery. A local Community Planning Group (CPG) facilitates 18-24 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.

Behavioral: Qungasvik-Healthy Hearts

Interventions

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.

Implement Qungasvik-Healthy Hearts 12-month community-based preventive intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alaska Fairbanks: lead

Study Sites (1)

University of Alaska Fairbanks

Fairbanks, Alaska, 99775, United States

Location

Related Publications (4)

• Allen J, Rasmus SM, Fok CCT, Charles B, Trimble J, Lee K; the Qungasvik Team. Strengths-Based Assessment for Suicide Prevention: Reasons for Life as a Protective Factor From Yup'ik Alaska Native Youth Suicide. Assessment. 2021 Apr;28(3):709-723. doi: 10.1177/1073191119875789. Epub 2019 Sep 20.

  PMID: 31538813 BACKGROUND

• Allen J, Charles B, Fok CCT, Lee K, Grogan-Kaylor A; Qungasvik Team; Rasmus S. Culturally grounded strategies for suicide and alcohol risk prevention delivered by rural Alaska Native communities: A dynamic wait-listed design evaluation of the Qungasvik intervention. Am J Community Psychol. 2023 Mar;71(1-2):184-197. doi: 10.1002/ajcp.12621. Epub 2022 Oct 10.

  PMID: 36214726 BACKGROUND

• Allen J, Rasmus SM, Fok CCT, Charles B, Henry D; Qungasvik Team. Multi-Level Cultural Intervention for the Prevention of Suicide and Alcohol Use Risk with Alaska Native Youth: a Nonrandomized Comparison of Treatment Intensity. Prev Sci. 2018 Feb;19(2):174-185. doi: 10.1007/s11121-017-0798-9.

  PMID: 28786044 BACKGROUND

• Rasmus SM, Charles B, John S, Allen J. With a Spirit that Understands: Reflections on a Long-term Community Science Initiative to End Suicide in Alaska. Am J Community Psychol. 2019 Sep;64(1-2):34-45. doi: 10.1002/ajcp.12356. Epub 2019 Jul 25.

  PMID: 31343758 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Stacy Rasmus, PhD

  University of Alaska Fairbanks

  PRINCIPAL INVESTIGATOR

• Jennifer Shaw

  University of Alaska Fairbanks

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacy Rasmus, PhD

CONTACT

907-474-7352; smrasmus@alaska.edu

Hannah Robinson, MPH

CONTACT

907-474-7659; hrobinson3@alaska.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To address the primary research questions, the study will use a dynamic wait-listed design (DWLD) involving 300 participants. To demonstrate measurable changes in cerebrovascular and cardiovascular risk factors, we will collect measures of diet, physical activity, social connectedness, and blood pressure across three time points: baseline (B), 6-month intervention midpoint (T1), and 12-month follow-up (T2). As a variant of a stepped-wedge group-randomized trial (SWGRT), the DWLD employs a repeated-measures, longitudinal crossover approach. Each participating community transitions from a control condition (the wait-list baseline) to the active intervention condition, with the timing of this crossover randomized across communities.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)