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

Trial Summary

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 data supports the effectiveness of the treatment DAiLY for heart disease?

Research shows that lifestyle changes, including diet and physical activity, can reduce the risk of death and major heart problems by 20% to 35% in people with heart disease. This suggests that the DAiLY treatment, which focuses on diet and active lifestyle, could be effective in managing heart disease. ^{1 2 3 4 5}

Is the Diet and Active Lifestyle treatment generally safe for humans?

Research shows that a healthy diet and active lifestyle are generally safe and can help reduce the risk of heart disease. Eating more fruits, vegetables, whole grains, and fish, while reducing unhealthy fats and processed foods, along with regular physical activity, is supported by studies as beneficial for heart health. ^{6 7 8 9 10}

How does the DAiLY treatment for heart disease differ from other treatments?

The DAiLY treatment is unique because it focuses on lifestyle changes, such as a Mediterranean diet and regular physical activity, rather than medication. This approach aims to reduce heart disease risk by improving diet and increasing exercise, which can lower cholesterol and blood pressure, unlike traditional drug treatments. ^{8 9 11 12 13}

What is the purpose of 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\'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.

Research Team

Bert B Boyer, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England 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. [2023]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The potential of lifestyle changes for improving the clinical outcome of patients with coronary heart disease: mechanisms of benefit and clinical results. [2019]

3. Sweden pubmed.ncbi.nlm.nih.gov

Feasibility of, and success in adopting a low-fat diet in coronary patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Home based versus centre based cardiac rehabilitation: Cochrane systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Dietary patterns and the risk of major adverse cardiovascular events in a global study of high-risk patients with stable coronary heart disease. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Diet Bioactive Compounds: Implications for Oxidative Stress and Inflammation in the Vascular System. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular disease: optimal approaches to risk factor modification of diet and lifestyle. [2020]

9. Finland pubmed.ncbi.nlm.nih.gov

Physiological interactions between diet and exercise in the etiology and prevention of ischaemic heart disease. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

New insights into the role of nutrition in CVD prevention. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of sustaining lifestyle modifications (nonsmoking, weight reduction, physical activity, and mediterranean diet) after healing of myocardial infarction, percutaneous intervention, or coronary bypass (from the REasons for Geographic and Racial Differences in Stroke Study). [2022]

12. England pubmed.ncbi.nlm.nih.gov

Lifestyle changes and clinical profile in coronary heart disease patients with an ejection fraction of 40% in the Multicenter Lifestyle Demonstration Project. [2011]

13. England pubmed.ncbi.nlm.nih.gov

The diet and moderate exercise trial (DAMET): results after 24 weeks. [2017]