Diet and Active Lifestyle - Yuuyaraq (The Yup'ik Way of Life)

NCT06629610 | Recruiting DMC

• 2 other identifiers: R01HL1688541R01HL168854
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 2

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\'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.

Conditions

Heart Disease

Keywords

Intervention; Alaska Native; Heart Disease; Community Health

Outcome Measures

Primary Outcomes (1)

• Continuous metabolic syndrome z score

  Determine the effectiveness of the DAiLY intervention on heart disease risk by measuring: (1) change in a continuous metabolic syndrome risk score (primary outcome) in Yup\'ik adults at least 18 years old. The continuous metabolic syndrome score includes the weighted contributions of waist circumference, triglycerides, high density lipoprotein, glucose and blood pressure. The continuous metabolic syndrome score is a metabolic syndrome-severity Z score that adds predictive utility for future heart disease above and beyond the individual metabolic syndrome components.

  From enrollment to the completion of post-intervention assessment (2 years)

Secondary Outcomes (9)

• Dietary pattern change

  From enrollment to the completion of post-intervention assessment (2 years)

• Moderate to Vigorous Physical Activity (MVPA)

  From enrollment to the completion of post-intervention assessment, with a mid-point assessment (2 years)

• Knowledge

  From enrollment to the completion of post-intervention assessment (2 years)

• Self-efficacy

  From enrollment to the completion of post-intervention assessment (2 years)

• Intentions

  From enrollment to the completion of post-intervention assessment (2 years)

Other Outcomes (8)

• Reach

  From beginning of intervention implementation to the completion of the intervention, about 2 years

• Community Impact

  From beginning of intervention implementation to the completion of the intervention, about 2 years

• Dose Delivered

  From beginning of intervention implementation to the completion of the intervention, about 2 years

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

This arm is made up of two communities that will receive the intervention at the beginning of the trial. The intervention includes three components, all supported by social media. Home-Based Workshops will be delivered by community members to increase knowledge and skills related to food choices, and to emphasize the importance of physical activity. Emphasis is placed on the benefits of consuming subsistence foods, as well as healthy store-bought foods. Food store modifications will increase access to healthy foods in local stores by working with store managers to stock and promote affordable healthy foods, and will provide participants with opportunities to implement what they have learned in workshops. Point of purchase promotions, educational displays, taste tests and cooking demonstrations, will identify and promote these foods. Physical activity promotion will include community-wide traditional activities, such as traditional dance, sports events, and berry festivals.

Behavioral: DAiLY

Delayed Intervention

EXPERIMENTAL

This arm is made up of two communities that will receive the intervention at the after the immediate arm. The intervention includes three components, all supported by social media. Home-Based Workshops will be delivered by community members to increase knowledge and skills related to food choices, and to emphasize the importance of physical activity. Emphasis is placed on the benefits of consuming subsistence foods, as well as healthy store-bought foods. Food store modifications will increase access to healthy foods in local stores by working with store managers to stock and promote affordable healthy foods, and will provide participants with opportunities to implement what they have learned in workshops. Point of purchase promotions, educational displays, taste tests and cooking demonstrations, will identify and promote these foods. Physical activity promotion will include community-wide traditional activities, such as traditional dance, sports events, and berry festivals.

Behavioral: DAiLY

Interventions

DAiLY BEHAVIORAL

The 2-year intervention includes three components, all supported by social media. Home-Based Workshops will be delivered by community members to increase knowledge and skills related to food choices, and to emphasize the importance of physical activity. Emphasis is placed on the benefits of consuming subsistence foods, as well as healthy store-bought foods. Food store modifications will increase access to healthy foods in local stores by working with store managers to stock and promote affordable healthy foods, and will provide participants with opportunities to implement what they have learned in HBWs. Point of purchase promotions, educational displays, taste tests and cooking demonstrations, will identify and promote these foods to community members. Physical activity promotion will include community-wide traditional activities, such as traditional dance, sports events, and berry festivals. Fitbits will be used as a motivational tool for participants to track their progress.

Delayed Intervention; Immediate Intervention

Eligibility Criteria

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Johns Hopkins Bloomberg School of Public Health: collaborator
• University of Alabama at Birmingham: collaborator
• Marshfield Clinic Research Foundation: collaborator
• University of Alaska Fairbanks: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Yukon-Kuskokwim Health Corporation

Bethel, Alaska, 99559, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

NOT YET RECRUITING

Related Publications (12)

• 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.

  PMID: 24598880 BACKGROUND

• Fienup-Riordan A. Eskimo Essays: Yup'ik Lives and How We See Them: Rutgers University Press; 1990.

  BACKGROUND

• 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.

  PMID: 24771075 BACKGROUND

• 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.

  PMID: 17060033 BACKGROUND

• 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.

  PMID: 30964405 BACKGROUND

• 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.

  PMID: 30115231 BACKGROUND

• 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.

  PMID: 30522637 BACKGROUND

• 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.

  PMID: 28267855 BACKGROUND

• 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.

  PMID: 22157543 BACKGROUND

• 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.

  PMID: 18237575 BACKGROUND

• 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.

  PMID: 36913463 BACKGROUND

• Alaska-Native-Epidemiology-Center. Alaska Native Mortality: 1980-2018. Anchorage: Alaska Native Tribal Health Consortium;2021.

  BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Bert B Boyer, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bert B Boyer, PhD

CONTACT

503-494-3368; boyerbe@ohsu.edu

Joel Gittelsohn, PhD

CONTACT

410-274-5310; jgittel1@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 8, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 7, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)