University of Alaska Fairbanks
Fairbanks, Alaska, 99775, United States
NCT Number: NCT07829341
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.
Trial opening soon.
Get Notified12 year and older
All sexes
Interventional
Not applicable
Fairbanks, Alaska, 99775, United States
Chronic disease is a primary contributor to mortality in the US, and while rates are rising in all populations, AIAN people remain disproportionately burdened. The remoteness and lack of acute care in rural Alaska Native (AN) communities, means that cardiovascular and cerebrovascular events are more likely to be catastrophic and have lower survivorship and recovery outcomes. Due to the remoteness, transportation challenges, and lack of access to medicine and healthcare, preventative health for chronic disease in rural AN communities is of utmost concern. During Phase I of the American Indian, Alaska Native, Native Hawaiian, Pacific Islander (AIAN NHPI) Enrichment Initiative, our Alaska site conducted a pilot implementation of the adapted culturally-grounded and evidence-based intervention known as Qungasvik-Healthy Hearts to assess feasibility and acceptability, as well as preliminary impact on cerebrovascular and cardiovascular disease risk in one rural AN community. The AK Enrichment Phase II project will expand the study in an effectiveness implementation hybrid type 1 trial conducted in three additional rural AN communities utilizing a dynamic waitlisted design (DWLD). Phase II will test intervention impacts with 300 individuals to determine clinical outcomes, including diet measured by nitrogen isotope ratios in hair, physical activity intensity and duration, social connectedness, and blood pressure, all primary risk and protective factors for chronic disease. The study has an intergenerational focus, addressing chronic disease prevention across the lifespan with an emphasis on young people's health and well-being in connection with older adults whose health and well-being is interdependent and connected to their transmission of cultural knowledge and subsistence practices to the upcoming generations of AN people. The primary goal will be to assess the culturally-grounded intervention's impact on the clinical outcome variables of cardiovascular and cerebrovascular disease risk factors, including traditional Yup'ik diet measured through nitrogen isotope ratios in hair, physical activity intensity and duration, social connectedness, and blood pressure.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1 Baseline(B) and 12-month follow-up (T2)
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: Points of Assessment: Baseline(B) and 12-month follow-up (T2)
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), 6-month intervention midpoint(T1), and 12-month follow-up (T2)
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)
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: Day 1 Baseline, 12 months
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.
Time frame: Day 1 Baseline, 12 months post follow-up
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.
Time frame: Day 1 Baseline, 6 months, 12 months
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.
Time frame: Day 1 baseline, 6 months, 12 months
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.
Time frame: Day 1, 6 months, 12 months
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.
Time frame: Day 1, 6 months, 12 months
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.
Time frame: Points of Assessment: Baseline(B), 6-month intervention midpoint(T1), and 12-month follow-up (T2)
Validated behavioral survey measure: NIH PROMIS
Time frame: Points of Assessment: Baseline(B), 6-month intervention midpoint(T1), and 12-month follow-up (T2)
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)
Validated behavioral survey measure PhenX Toolkit
Time frame: Day 1 Baseline, 6 months, 12 months
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, 6 months, 12 months
We include a self-report measure of physical activity that is tailored to normative activities that people engage in rural Alaska Native communities including asking about daily, activities such as walking, cleaning the house, cooking food, fixing a vehicle, chopping wood, processing game, etc.
Contact information is provided by the study sponsor or research team.
Hannah Robinson, MPH
CONTACT
Stacy Rasmus, PhD
CONTACT
University of Alaska Fairbanks
Other
Qungasvik (Toolbox)-Healthy Hearts: An Alaska Enrichment Initiative (AK Enrichment)
Acronym: AK CEAL EI
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