DASH Diet + Patient Education for Asthma

(ALOHA Trial)

Recruiting at 1 trial location

Overseen By Jun Ma, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Illinois at Chicago

Must be taking: Controller therapy

Must not be taking: Weight-loss products

Disqualifiers: COPD, Cardiovascular disease, Diabetes, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 52 weeks

320 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the ALOHA trial is to investigate the efficacy of improved diet quality following a DASH behavioral intervention that has shown promising results in adults with uncontrolled asthma. DASH stands for Dietary Approaches to Stop Hypertension. This healthy diet is known to help people with high blood pressure manage their health. But physicians do not know if the DASH diet can also benefit patients with uncontrolled asthma. Researchers in the ALOHA study are trying to find out the answer to this important question. Researchers at UIC are studying how 2 asthma care programs compare in terms of helping adults with uncontrolled asthma to improve their quality of life. Researchers also want to learn what might explain the differences in patient outcomes that they may see between the 2 programs. The primary outcome will be asthma-specific quality of life. If the DASH behavioral intervention is found to benefit people with uncontrolled asthma, it would provide a practical, safe, and acceptable public-health intervention in the form of dietary modification to reduce the burden of asthma.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require you to stop using any prescription or non-prescription weight-loss products for the duration of the study.

What data supports the effectiveness of the DASH Diet as a treatment for asthma?

Research suggests that the DASH Diet, which is known for improving heart health, may also help people with asthma by improving diet quality and asthma control. A study showed potential benefits of this diet for adults with uncontrolled asthma, indicating it could be a helpful addition to asthma management. ^{1 2 3 4 5}

Is the DASH diet safe for humans?

The DASH diet is generally safe for most people and is recommended by health guidelines. However, caution is advised for individuals with chronic kidney or liver disease, and those on certain medications, as modifications may be needed. ^{1 2 6 7 8}

How is the DASH Diet treatment different from other asthma treatments?

The DASH Diet treatment for asthma is unique because it focuses on improving diet quality by promoting high intake of fruits, vegetables, and lean proteins while reducing salt and unhealthy fats, which is different from traditional asthma treatments that typically involve medications. This approach aims to improve asthma control by addressing dietary risk factors rather than relying solely on medication. ^{1 2 7 9 10}

Research Team

Jun Ma, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

Adults over 18 with uncontrolled asthma, as indicated by an Asthma Control Test score below 20, and on prescribed controller therapy can join. They must understand English well enough for informed consent. Exclusions include recent cancer treatment, COPD diagnosis, diabetes outside pregnancy, significant weight change or dieting attempts recently, certain cardiovascular diseases, smoking history or current use, cognitive impairments or severe mental health issues within the last two years.

Inclusion Criteria

I am 18 years old or older.

I have asthma and am on a prescribed treatment plan.

My asthma is not well-controlled, with an ACT score below 20.

Exclusion Criteria

I have smoked more than 20 packs of cigarettes in my lifetime or am currently smoking.

Planning to move out of the area during the study period

I have diabetes not related to pregnancy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of two asthma care programs, including patient education and potentially nutrition counseling, over a 1-year period

52 weeks

3 individual sessions, 8 group sessions, 11 phone consultations

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

4 visits (in-person) at baseline, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• DASH Dietary Pattern

Trial Overview The ALOHA trial is testing if a DASH dietary intervention improves quality of life in adults with uncontrolled asthma compared to standard patient education. The DASH diet is known to help with high blood pressure but its effects on asthma are unknown. Group B receives nutrition counseling plus education; Group A gets only education.

Participant Groups

Group I: Group B - Patient Education with Nutrition Counseling Active Control 1 Intervention

If you are assigned to this group, you will receive the same patient education on asthma and health as Group A. In addition, you will receive nutrition counseling from your health coach who is a registered dietitian.

Group II: Group A - Patinet Education Active Control 1 Intervention

If you are assigned to this group, you will receive education on asthma and health from an ALOHA health coach.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Newcastle, Australia

Collaborator

Trials

12

Recruited

6,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Findings from Research

A clinical trial involving 320 adults with uncontrolled asthma will assess the effectiveness of a DASH dietary intervention combined with sodium reduction, aiming to improve asthma-specific quality of life over 12 months.

The study will also explore the mechanisms behind dietary effects on asthma by measuring therapeutic and nutritional biomarkers, potentially providing new insights into how diet quality influences asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the DASH dietary pattern on clinical outcomes and quality of life in adults with uncontrolled asthma: Design and methods of the ALOHA Trial. Nyenhuis, SM., Dixon, A., Wood, L., et al.[2023]

A 6-month DASH dietary intervention improved diet quality and asthma control in 90 adults with uncontrolled asthma, showing a significant difference in Asthma Control Questionnaire scores compared to the usual-care control group.

While the improvements in asthma control and quality of life were modest, they suggest potential clinical significance, indicating that dietary changes could be beneficial for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma. Ma, J., Strub, P., Lv, N., et al.[2018]

A 2-month intervention led by a nurse practitioner for 45 overweight and obese hypertensive patients resulted in significant improvements in diet and lifestyle, as measured by standardized questionnaires.

Participants experienced an average weight loss of 3.6 pounds, indicating that the DASH diet and lifestyle changes were effective in promoting better health outcomes in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. Jarl, J., Tolentino, JC., James, K., et al.[2021]

The DASH Quality (DASH-Q) measure was developed and validated to assess adherence to the DASH diet among adults, showing good internal consistency (α = .77-.83) across two diverse samples totaling 812 participants.

The DASH-Q demonstrated strong correlations with existing nutrition scales and behaviors, indicating its effectiveness as a reliable tool for evaluating diet quality and adherence to the DASH diet, which is important for managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Validation of a Brief Self-report Measure of Diet Quality: The DASH-Q. Warren-Findlow, J., Reeve, CL., Racine, EF.[2018]

The 'DASH for Asthma' trial, involving 90 adults with uncontrolled asthma, showed that a dietary intervention significantly improved diet quality and asthma control over 6 months, indicating its potential as an effective management strategy.

Participants and lifestyle coaches reported high satisfaction with the program, highlighting the importance of personalized feedback, social learning, and engaging activities like food tasting in enhancing self-efficacy and overall program acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of the 'DASH for Asthma' intervention in a randomized controlled trial pilot study. Blonstein, AC., Lv, N., Camargo, CA., et al.[2023]

In a study of adults with poorly controlled asthma, adopting the DASH diet was linked to significant reductions in inflammatory markers associated with asthma, including proinflammatory cytokines and T-helper cell associated proteins, over a 6-month period.

Improved diet quality was correlated with better asthma control, suggesting that dietary interventions like the DASH diet could be an effective strategy for managing asthma symptoms and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved diet quality is associated with decreased concentrations of inflammatory markers in adults with uncontrolled asthma. Nygaard, UC., Xiao, L., Nadeau, KC., et al.[2023]

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

The DASH dietary pattern is linked to a significant reduction in the incidence of cardiovascular disease (CVD) by 20%, coronary heart disease by 21%, stroke by 19%, and diabetes by 18%, based on a review of 15 studies involving over 942,000 participants.

In controlled trials, the DASH diet led to notable improvements in blood pressure, with a decrease in systolic blood pressure by 5.2 mmHg and diastolic blood pressure by 2.6 mmHg, along with reductions in total cholesterol, LDL cholesterol, HbA1c, fasting insulin, and body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DASH Dietary Pattern and Cardiometabolic Outcomes: An Umbrella Review of Systematic Reviews and Meta-Analyses. Chiavaroli, L., Viguiliouk, E., Nishi, SK., et al.[2020]

A study of 2,831 adults in Iran found that adherence to the DASH diet is associated with lower levels of cardiovascular risk factors, including blood pressure, fasting blood sugar, triglycerides, and cholesterol.

Specifically, individuals in the highest quintile of DASH diet adherence had a 28% lower odds of hyperglycemia, suggesting that the DASH diet may be effective in reducing the risk of diabetes and other cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. Shoaibinobarian, N., Danehchin, L., Mozafarinia, M., et al.[2023]

In a study of 144 overweight or obese adults with high blood pressure, those following the DASH diet alone or with weight management experienced significant reductions in blood pressure compared to those on a usual diet, highlighting the diet's efficacy as a nonpharmacologic treatment.

Greater adherence to the DASH diet was linked to larger decreases in blood pressure, and the study found that African Americans had lower adherence rates, suggesting the need for culturally tailored dietary strategies to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. Epstein, DE., Sherwood, A., Smith, PJ., et al.[2022]

References

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

The effects of the DASH dietary pattern on clinical outcomes and quality of life in adults with uncontrolled asthma: Design and methods of the ALOHA Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma. [2018]

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

Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. [2021]

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

Psychometric Validation of a Brief Self-report Measure of Diet Quality: The DASH-Q. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Acceptability and feasibility of the 'DASH for Asthma' intervention in a randomized controlled trial pilot study. [2023]

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

Improved diet quality is associated with decreased concentrations of inflammatory markers in adults with uncontrolled asthma. [2023]

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

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

DASH Dietary Pattern and Cardiometabolic Outcomes: An Umbrella Review of Systematic Reviews and Meta-Analyses. [2020]

9. Iran pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]

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

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. [2022]