Clinical trial NCT06629610: Diet and Active Lifestyle - Yuuyaraq (The Yup'ik Way of Life)
Official title: A Community-led Intervention (DAiLY) Promoting a Heart-healthy Diet and Active Lifestyle: The Yup&#39;ik Way
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Disease
Keywords: Intervention
Alaska Native
Heart Disease
Community Health
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Bloomberg School of Public Health
name: University of Alabama at Birmingham
name: Marshfield Clinic Research Foundation
name: University of Alaska Fairbanks
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-10-08
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Heart disease is the leading cause of death for Alaska Native men and the second leading cause of death (after cancer) among women and Alaska Native people overall. The overarching goal of the proposed multilevel, multicomponent intervention, Diet and Active Lifestyle - Yuuyaraq (DAiLY), is to reduce consumption of highly processed store-bought foods while promoting intake of subsistence foods, healthy store-bought foods, and a more active lifestyle to reduce heart disease risk. The Yup\&amp;amp;#39;ik word Yuuyaraq means 'the Yup'ik way of life' and encompasses a worldview in which living in harmony with the environment, as well as sharing of subsistence foods and traditional knowledge is central. The proposed DAiLY intervention is grounded in the Yup'ik worldview and Indigenous Food Sovereignty, and supported by a foundation of trust resulting from 22 years of continuous Community Based Participatory Research on heart disease risk andprotective factors with Yup'ik communities. DAiLY is a direct response to the intervention research requests of community partners and input from Yup'ik Community Research Associates and a Yup'ik Community Planning Group during the formative research and community engagement process shaping this proposal. The proposed intervention, based on the Warnecke model of health disparities and social cognitive theory, includes three components: 1) home-based workshops, framed in the Yupik worldview, led by Community Research Associates to facilitate interactive discussions with community members about healthy market foods, as well as the health benefits of locally harvested traditional foods and increased physical activity; 2) local food store interventions to increase access to, and help build demand for, healthy food options; and 3) traditional community activities, including Yuraq (Yup'ik traditional dance), Native sports events, and berry festivals, that provide opportunities to increase physical activity. The three components will be supported and reinforced via community media, including Facebook, text messaging and visual materials. A continuous metabolic syndrome score will be used as the primary outcome to assess changes in heart disease risk, and objective stable isotope biomarkers of diet and a validated food frequency questionnaire will be used to measure intake of traditional and market foods. We will test the DAiLY intervention in four Yupik communities, randomized to immediate and delayed intervention. Aim 1, will determine the effectiveness of the DAiLY intervention on heart disease risk by measuring change in a continuous metabolic syndrome risk score (primary outcome). Aim 2, will assess implementation of the DAiLY intervention using a mixed methods process evaluation to determine fidelity, dose, and reach, as well as barriers and facilitators to implementation of program activities and participant satisfaction and engagement. Aim 3, will determine the impact of the DAiLY intervention on community-level outcomes, including access to, and sales of, healthy foods in local stores, as well as opportunities for physical activity at community venues.

Detailed description: Background Heart disease (HD) is the leading cause of death for Alaska Native men and the second leading cause of death among women. HD mortality among the Yup\&amp;#39;ik Alaska Native people is 30% higher than that for all races in the U.S. The traditional Yup\&amp;#39;ik diet is associated with a reduction in multiple risk factors for HD, but over the past 60 years, this dietary pattern has been replaced by a shift toward ultra-processed foods high in saturated fat, salt and sugar which have been linked to increased risk for HD. At the same time, there has been a shift to a more sedentary lifestyle. The goal of this project is to determine the effectiveness of a culturally adapted intervention to reduce HD risk among Yup\&amp;amp;#39;ik Alaska Native people by encouraging increased consumption of heart healthy traditional and market foods, as well as increased physical activity.

Intervention Approach This work adheres to a Community-Based Participatory Research (CBPR) framework, which depends heavily upon community engagement and partnership throughout the entire research process, and Indigenous Food Sovereignty (IFS), a concept that represents Indigenous peoples\&#39; ability to control their food systems, including the production, distribution, and consumption of food. The Yup\&amp;amp;#39;ik word Yuuyaraq means \&amp;amp;#39;the Yup\&amp;amp;#39;ik way of life\&amp;amp;#39; and it encompasses the Yup\&amp;amp;#39;ik worldview which is founded on traditional values of respect for humans, animals, and the environment in which they live, sharing of resources (including subsistence foods), sharing stories and knowledge, and an interpersonal relationship with nature as a source of wellness. The proposed intervention, Diet and Active Lifestyle- Yuuyaraq (DAiLY), is based on Yup\&amp;amp;#39;ik worldview principles.

DAiLY Intervention Components The intervention will be delivered through three complementary components, each supported and reinforced by community media, including social media (Facebook), texting and visual materials.

1. Home-Based Workshops (HBWs) will be delivered by trained members of the local community. The aim of the HBWs is to increase knowledge, skills and confidence related to to food (e.g., understanding nutrition labels, the benefits of traditional foods, supporting traditional subsistence and harvesting practices, making healthy market food choices, and healthy food preparation and serving methods), as well as participants\&amp;amp;#39; awareness of the importance of physical activity and maintaining a healthy weight. An emphasis is placed on understanding the benefits of consuming traditional subsistence foods, as well as heart-healthy foods from the local stores to complement the traditional diet.
2. Food store modifications will increase access to heart-healthy foods in local stores by working with store managers to stock and promote affordable healthy food options, which will in turn provide participants with the opportunity to implement what they have learned in the HBWs. Point of purchase promotions in stores, including educational displays, taste tests and cooking demonstrations, and temporary price reductions to build demand, will identify and promote these foods to community members.
3. Physical Activity (PA) opportunities will be increased, and will include community-based activities that have been identified by community members. These will emphasize traditional activities, such as Yuraq traditional Yup\&amp;amp;#39;ik Dance, Native sports events, and berry festivals. Fitbits will be given to participants and used as a motivational tool to encourage and allow participants to track their PA progress during and after the intervention.

Implementation and Assessment Community research associates (CRAs) will implement the DAiLY intervention after being trained by the study team, with follow-up booster trainings as needed. The intervention will be carried out in four communities, two of which will participate first (immediate intervention), allowing for comparison of outcomes among those who have and have not yet received the intervention. Once the follow-up data collection is complete, the second two communities (delayed intervention) will receive the intervention. Throughout all phases of the intervention, data will be collected about how well and to what extent the DAiLY intervention was implemented by the study team in each community.

The impact of the DAiLY intervention will be measured through changes in individual participants heart disease risk factors, as well as in the community food stores and in terms of access to increased PA opportunities at the community level. Participants will be asked to donate a fasting blood sample to measure the different factors that affect risk for heart disease, and study investigators (Boyer and Hopkins) will measure participants\&amp;amp;#39; weight, blood pressure and waist circumference. ActiGraph GT3X+, high-resolution triaxial accelerometers will be used to measure physical activity levels, in addition to completing a Yup\&amp;amp;#39;ik Wellness Questionnaire to assess participation in traditional and community activities and confidence to adopt healthy behaviors. In addition, a Yup\&amp;amp;#39;ik Food Frequency Questionnaire will be used to assess how participants report changes in dietary patterns and knowledge of healthy dietary behaviors. In community food stores, data will be collected on stocking and sales of promoted foods in store, as well as food store owners\&amp;amp;#39; and managers\&amp;amp;#39; expectations of sales of healthy food before and after the DAiLY intervention. We will also monitor changes in the availability, use (# people), PA quality and duration of community traditional PA opportunities. Physical activity opportunities in the community will be coordinated with the HBW modules and will include communityevents and subsistence activites. CRAs will receive $2000 per community to sponsor community-wide events. These activities will be initiated and promoted as part of the DAiLY including community campaigns to \&amp;amp;#34;park it and walk\&amp;amp;#34; to limit use of of snow machines and ATVs in the community, Fitbit step challenges, initiation of women\&amp;amp;#39;s \&amp;amp;#34;walking groups\&amp;amp;#34; to gather their children at evening curfew, promotion of cultural events such as Yuraq traditional Yup\&amp;amp;#39;ik dance, holding berry festivals (including picking competitions) and supporting additional sports events (basketball, volleyball and Native games) in the school gyms. All of these community-level activities were suggested by our CPG.

Overall Project Aims Aim 1: Determine the effectiveness of the DAiLY intervention on HD risk by measuring: (1) change in a continuous metabolic syndrome (cMS) risk score (primary outcome) in Yup\&amp;amp;#39;ik adults; and (2) secondary outcomes including PA (using accelerometry), dietary change using objectively measured biomarkers, as well as dietary consumption, and change in psychosocial measures (i.e., knowledge, self-efficacy and intentions).

Aim 2: Assess implementation of the DAiLY intervention using a mixed methods process evaluation using a sequential explanatory design to determine: (1) reach, dose delivered, and fidelity; (2) barriers and facilitators to implementing program activities; and (3) participant satisfaction and engagement. Aim 3: Determine the impact of the DAiLY intervention on community-level outcomes including: (1) access to, and sales of, healthy foods in local stores; (2) access to community venues (e.g., school gyms and community halls for PA); and (3) frequency and level of engagement in subsistence activities and community-wide events.

Sharing Results and Dissemination of Program Materials A major objective of DAiLY is to share the results with the participating communities, as well as others who develop health promotion programs. The study team will continuously share the progress and results of the intervention with local community Tribal governments and healthcare leaders in order to ensure the communities that participated can determine next steps in their best interest. After completion of the trial, all intervention materials will be made available and freely downloadable from the study website.

Eligibility criteria: Inclusion Criteria:

* Participants Inclusion criteria: Self-identify as Yup\&#39;ik Alaska Native, Lives in a participating Yup\&#39;ik community, Does not plan to move out of the community throughout the intervention (24 months), 18 years of age or older.
* Communities Inclusion criteria: Willing to participate in the DAiLY intervention as evidenced by letters of support for the intervention study provided by community Tribal governments; Willing and ready to participate in the Community Based Participatory Research process (Community Planning Group, Home-based Workshops, Food Store Component, review of research outcomes) Food stores Inclusion Criteria: Located within the participating community, Store commonly used by community members, Does not anticipate closing permanently during the intervention period, Tribal Corporation stores (governed by Tribal Council) willing and able to facilitate all of the following intervention components at their food store: allow interactive sessions / taste tests in their food store, increase stocking of healthy foods and beverages, allow display of intervention shelf labels and other educational materials in their store (e.g., posters, flyers)

Exclusion Criteria:

* Participants Exclusion criteria: Currently pregnant (as dietary intake and PA recommendations differ during pregnancy), Anticipates moving out of the community in the next 24 months, Age is under 18 years of age, Participated in the pilot intervention

Primary outcomes:
measure: Continuous metabolic syndrome z score
timeFrame: From enrollment to the completion of post-intervention assessment (2 years)
Secondary outcomes:
measure: Dietary pattern change
timeFrame: From enrollment to the completion of post-intervention assessment (2 years)
measure: Moderate to Vigorous Physical Activity (MVPA)
timeFrame: From enrollment to the completion of post-intervention assessment, with a mid-point assessment (2 years)
measure: Knowledge
timeFrame: From enrollment to the completion of post-intervention assessment (2 years)
measure: Self-efficacy
timeFrame: From enrollment to the completion of post-intervention assessment (2 years)
measure: Intentions
timeFrame: From enrollment to the completion of post-intervention assessment (2 years)
measure: Nitrogen Isotope Ratio (NIR)
timeFrame: From enrollment to the completion of post-intervention assessment (2 years)
measure: Carbon Isotope Ratio (CIR)
timeFrame: From enrollment to the completion of post-intervention assessment (2 years)
measure: Total Physical Activity
timeFrame: From enrollment to the completion of post-intervention assessment, with a mid-point assessment (2 years)
measure: Sedentary Time
timeFrame: From enrollment to the completion of post-intervention assessment, with a mid-point assessment (2 years)
Other outcomes:
measure: Reach
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
measure: Community Impact
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
measure: Dose Delivered
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
measure: Fidelity
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
measure: Barriers to Intervention Implementation
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
measure: Facilitators for intervention implementation
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
measure: Participant Satisfaction
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
measure: Participant Engagement
timeFrame: From beginning of intervention implementation to the completion of the intervention, about 2 years
Locations:
city: Bethel
country: United States
facility: Yukon-Kuskokwim Health Corporation
state: Alaska
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Bert B Boyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fienup-Riordan A. Eskimo Essays: Yup'ik Lives and How We See Them: Rutgers University Press; 1990.
citation: Ayunerak P, Alstrom D, Moses C, Charlie J Sr, Rasmus SM. Yup'ik culture and context in Southwest Alaska: community member perspectives of tradition, social change, and prevention. Am J Community Psychol. 2014 Sep;54(1-2):91-9. doi: 10.1007/s10464-014-9652-4.
citation: 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.
citation: Ray L, Burnett K, Cameron A, Joseph S, LeBlanc J, Parker B, Recollet A, Sergerie C. Examining Indigenous food sovereignty as a conceptual framework for health in two urban communities in Northern Ontario, Canada. Glob Health Promot. 2019 Apr;26(3_suppl):54-63. doi: 10.1177/1757975919831639.
citation: Yu E, Malik VS, Hu FB. Cardiovascular Disease Prevention by Diet Modification: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Aug 21;72(8):914-926. doi: 10.1016/j.jacc.2018.02.085.
citation: Schwarz PEH, Timpel P, Harst L, Greaves CJ, Ali MK, Lambert J, Weber MB, Almedawar MM, Morawietz H. Reprint of: Blood Sugar Regulation for Cardiovascular Health Promotion and Disease Prevention: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt B):3071-3086. doi: 10.1016/j.jacc.2018.10.026.
citation: Micha R, Penalvo JL, Cudhea F, Imamura F, Rehm CD, Mozaffarian D. Association Between Dietary Factors and Mortality From Heart Disease, Stroke, and Type 2 Diabetes in the United States. JAMA. 2017 Mar 7;317(9):912-924. doi: 10.1001/jama.2017.0947.
citation: Nash SH, Bersamin A, Kristal AR, Hopkins SE, Church RS, Pasker RL, Luick BR, Mohatt GV, Boyer BB, O'Brien DM. Stable nitrogen and carbon isotope ratios indicate traditional and market food intake in an indigenous circumpolar population. J Nutr. 2012 Jan;142(1):84-90. doi: 10.3945/jn.111.147595. Epub 2011 Dec 7.
citation: Bersamin A, Luick BR, King IB, Stern JS, Zidenberg-Cherr S. Westernizing diets influence fat intake, red blood cell fatty acid composition, and health in remote Alaskan Native communities in the center for Alaska Native health study. J Am Diet Assoc. 2008 Feb;108(2):266-73. doi: 10.1016/j.jada.2007.10.046.
citation: Boyer BB, Wiener HW, Hopkins SE, Purnell JQ, O'Brien DM, Aliwarga T, Pomeroy JJ, Aslan JE, Thummel KE, Tiwari HK. Obesity-Associated Dyslipidemia Is Moderated by Habitual Intake of Marine-Derived n-3 Polyunsaturated Fatty Acids in Yup'ik Alaska Native People: A Cross-Sectional Mediation-Moderation Analysis. J Nutr. 2023 Jan;153(1):279-292. doi: 10.1016/j.tjnut.2022.10.009. Epub 2022 Dec 21.
citation: Alaska-Native-Epidemiology-Center. Alaska Native Mortality: 1980-2018. Anchorage: Alaska Native Tribal Health Consortium;2021.