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Behavioural Intervention

Diet and Active Lifestyle for Heart Disease (DAiLY Trial)

N/A

Waitlist Available

Led By Bert B Boyer, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Store commonly used by community members

18 years of age or older

Must not have

Age is under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the completion of post-intervention assessment (2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce the risk of heart disease among Alaska Native communities by promoting a healthier lifestyle. The intervention, called Diet and Active Lifestyle - Yuuyaraq (DAiLY), focuses on

Who is the study for?

This trial is for Alaska Native men and women at risk of heart disease. Participants should be interested in adopting a diet rich in traditional foods and an active lifestyle, following the Yup'ik way of life. The study seeks individuals willing to engage with home-based workshops, local food store changes, and community activities.

What is being tested?

The DAiLY intervention aims to reduce heart disease by encouraging consumption of subsistence foods and healthy store-bought items while promoting physical activity through workshops, improved food access, and traditional events. Its effectiveness will be measured using metabolic syndrome scores.

What are the potential side effects?

There are no direct side effects from participating as this trial focuses on dietary changes and increased physical activity rather than medication or medical procedures. However, lifestyle adjustments may cause temporary discomfort or require time to adapt.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I shop at stores popular within my community.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the completion of post-intervention assessment (2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the completion of post-intervention assessment (2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the completion of post-intervention assessment (2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Continuous metabolic syndrome z score

Secondary study objectives

Carbon Isotope Ratio (CIR)

Dietary pattern change

Intentions

+6 more

Other study objectives

Barriers to Intervention Implementation

Community Impact

Dose Delivered

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Immediate InterventionExperimental Treatment1 Intervention

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.

Group II: Delayed InterventionExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met