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

ConditionHeart Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorOregon Health and Science University

About this trial

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;#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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants Inclusion criteria: Self-identify as Yup'ik Alaska Native, Lives in a participating Yup'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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

368 Participants

are divided into 2 treatment groups

Group A: Immediate InterventionExperimental treatment 1 intervention

Group B: Delayed InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Dietary pattern change

We will assess dietary consumption with a food frequency questionnaire validated for use in Yup\'ik communities.

Time frame

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

Moderate to Vigorous Physical Activity (MVPA)

We will measure moderate to vigorous physical activity (MVPA) levels using accelerometry. Wrist-worn Actigraph GT3X+ monitors will be used. MVPA will be assessed using established wrist-worn accelerometry cutpoints and calculated as average minutes per day.

Time frame

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

Knowledge

The knowledge score assesses adult participants\' knowledge of nutrition and physical activity (PA) behaviors emphasized in the intervention. Ten multiple choice questions cover topics such as dietary fiber, sugar, and nutrition label reading (alpha=0.63). An example is \"Which kind of bread has the most fiber? a) Fry bread; b) White bread; c) 100% whole wheat bread; d) Don\'t know\"

Time frame

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

Self-efficacy

The self-efficacy scale assesses the confidence that the respondent feels to carry out healthy physical activity and dietary behaviors. Eleven questions ask the respondent to categorize healthy behaviors as either \"easy\" or \"difficult\" within their lives (alpha=0.63). An example question is, \"Would it be difficult or easy for you to choose water instead of regular soda?\"

Time frame

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

Other outcomes

Reach

We will assess implementation of the DAiLY intervention by measuring reach of our trial. Reach refers to the number of individuals in the target audience participating in the intervention. Community Research Associates will document their work using structured Interventionist logs as they conduct each intervention component.

Time frame

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

Community Impact

We will assess impact of the DAiLY intervention on community-level outcomes including: (1) access to, and sales of, healthy foods in local stores; and (2) access to community venues. We will modify a previously developed, successfully used, instrument for assessing the reported stocking and unit sales of promoted foods, outcome expectations of promoted food sales and effect of promotions on overall store sales and will be administered to store managers at two timepoints. A store food availability checklist form will be adapted for use in the Yupik community setting by including the specific foods and beverages that will be promoted for the DAiLY intervention. This instrument assesses availability of key promoted foods in food stores via a simple checklist and will be administered by the comm every two weeks in each of the community stores to allow for immediate midcourse correction where necessary. We will assess engagement in community events and school gym activities.

Time frame

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

Dose Delivered

We will assess implementation of the DAiLY intervention by measuring the dose delivered of the trial. Dose delivered refers to the amount of time or the frequency that each activity is performed. Community Research Associates will document their work using structured Interventionist logs as they conduct each intervention component.

Time frame

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

Fidelity

We will assess implementation of the DAiLY intervention by measuring fidelity. Fidelity refers to the engagement by the target audience in each of these activities. Community Research Associates will document their work using structured Interventionist logs as they conduct each intervention component.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

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

Source ClinicalTrials.gov

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