Diet and Active Lifestyle for Heart Disease

(DAiLY Trial)

Recruiting at 1 trial location

Overseen By Joel Gittelsohn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Pregnancy, Moving, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

368 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce heart disease risk among Yup'ik Alaska Native communities by promoting healthier eating and more active lifestyles. It encourages reducing processed foods and increasing the intake of traditional and healthy store-bought foods, along with promoting physical activities such as traditional dance and sports. The trial suits Yup'ik Alaska Natives living in participating communities who plan to stay there for the next two years. As an unphased trial, it offers participants the chance to contribute to community health improvements and benefit from healthier lifestyle changes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the DAiLY intervention is safe for reducing heart disease risk?

Research has shown that lifestyle changes, such as improving diet and increasing exercise, are safe and can effectively lower the risk of heart disease. Studies have found that these changes help reduce weight, blood pressure, and blood sugar levels, all crucial for heart health. The DAiLY program promotes healthy eating and regular physical activity, which most people manage well. Previous research supports that living a heart-healthy lifestyle is not only safe but also beneficial for long-term health. No reports of serious side effects have emerged from similar programs, suggesting that joining the DAiLY program should be a safe option for those seeking to improve heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DAiLY intervention because it offers a holistic and community-driven approach to managing heart disease. Unlike conventional treatments that often focus on medication and clinical settings, DAiLY emphasizes lifestyle changes supported by social media. It incorporates home-based workshops that empower participants with knowledge about food choices and physical activity, while also modifying local food stores to improve access to healthy foods. By engaging communities through traditional activities like dance and sports, it fosters an inclusive and culturally relevant environment for promoting heart health. This innovative approach could lead to sustainable lifestyle changes, potentially reducing heart disease risk on a broader scale.

What evidence suggests that the DAiLY intervention could be effective for reducing heart disease risk?

Research has shown that lifestyle changes, such as healthier eating and increased activity, can lower the risk of heart disease. Studies have found that these changes can result in some weight loss and improved heart health. For instance, some studies reported a 2.23% reduction in the risk of heart and blood vessel problems among those who adopted these habits. The DAiLY program in this trial focuses on promoting healthy eating and physical activity, aligning with these proven methods. This approach aims to reduce heart disease risk by encouraging better diet choices and active living. Participants will join either an Immediate Intervention arm or a Delayed Intervention arm, both designed to implement these lifestyle changes. ^{1 6 7 8 9}

Who Is on the Research Team?

Bert B Boyer, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Self-identify as Yup'ik Alaska Native

Live in a participating Yup'ik community

Do not plan to move out of the community throughout the intervention (24 months)

Exclusion Criteria

Anticipates moving out of the community in the next 24 months

Currently pregnant (as dietary intake and PA recommendations differ during pregnancy)

Participated in the pilot intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

The DAiLY intervention is implemented in the community, including home-based workshops, food store modifications, and physical activity opportunities.

2 years

Ongoing community engagement and activities

Follow-up

Participants are monitored for changes in heart disease risk factors and community-level outcomes after the intervention.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• DAiLY

Trial Overview 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.

How Is the Trial Designed?

Group I: Immediate Intervention Experimental Treatment 1 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 Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials

441

Recruited

2,157,000+

Marshfield Clinic Research Foundation

Collaborator

Trials

15

Recruited

10,200+

University of Alaska Fairbanks

Collaborator

Trials

10

Recruited

14,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 72 participants in a lifestyle modification program, those with elevated cardiovascular disease (CVD) risk factors but no clinical disease showed equal or greater improvements in heart health compared to those with existing CVD.

The results indicate that intensive lifestyle change programs can be effective for primary prevention of CVD, highlighting their importance for individuals at increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Ellsworth, DL., O'Dowd, SC., Salami, B., et al.[2019]

A systematic review of 40 trials involving 35,548 participants found that Mediterranean dietary programmes significantly reduce all-cause mortality, cardiovascular mortality, stroke, and non-fatal myocardial infarction compared to minimal interventions, indicating their efficacy in patients at increased cardiovascular risk.

Low fat dietary programmes also showed effectiveness in reducing all-cause mortality and non-fatal myocardial infarction, but there were no significant differences in outcomes between Mediterranean and low fat diets, suggesting both are beneficial for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of seven popular structured dietary programmes and risk of mortality and major cardiovascular events in patients at increased cardiovascular risk: systematic review and network meta-analysis. Karam, G., Agarwal, A., Sadeghirad, B., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06629610

Diet and Active Lifestyle - Yuuyaraq (The Yup'ik Way of Life) Determine the effectiveness of the DAiLY intervention on heart disease risk by measuring: (1) change in a continuous metabolic syndrome risk score (primary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460604/

Impact of Lifestyle Modifications on Cardiovascular Health It showed that intensive lifestyle interventions resulted in modest weight loss and improved cardiovascular risk factors [41].

3. sciencedirect.com sciencedirect.com/science/article/pii/S0939475325002844

The effectiveness of lifestyle interventions in reducing ... A significant reduction in CVD risk, up to 2.23 %, was observed in the intervention groups in four of the studies [26,41,49,50] while no significant effect was ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001349

Implementation of Evidence-Based Behavioral ... AHA LE8 indicates American Heart Association Life's Essential 8: (1) eat better, (2) be more active, (3) quit tobacco, (4) get healthy sleep, (5) ...

5. withpower.com withpower.com/trial/phase-heart-diseases-9-2024-c47c4

Diet and Active Lifestyle for Heart Disease (DAiLY Trial) What data supports the effectiveness of the treatment DAiLY for heart disease? Research shows that lifestyle changes, including diet and physical activity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10128075/

A Heart-Healthy Diet for Cardiovascular Disease Prevention Lifestyle modifications from exercise and dietary interventions have been well studied and proven effective toward CVD prevention and management ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S003306202100133X

The importance of healthy lifestyle behaviors in ... Obtaining adequate amounts of PA and adhering to a heart-healthy dietary pattern can lead to important reductions in weight, blood pressure, blood glucose, and ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCRESAHA.123.321998

Life Course Cardiovascular Health: Risk Factors ... CVH measured at any point in life is strongly predictive of future cardiovascular disease, dementia, cancer, and mortality as well as a variety of other health ...

9. academic.oup.com academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwaf310/8161061

Diet and nutrition in cardiovascular disease prevention A meta-analysis of 13 cohort studies suggested that a vegetarian diet was associated with ∼15% lower risk of CVD and 20% lower risk of ischaemic ...