Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Feb 11, 2022

Keywords

ClinConnect Summary

The ALOHA trial is a research study designed to explore whether following a specific healthy eating plan, known as the DASH diet, can help adults with uncontrolled asthma improve their quality of life. The DASH diet is often recommended for managing high blood pressure, but researchers want to see if it can also benefit asthma patients. The study will compare two different asthma care programs to see which one leads to better outcomes for those struggling with asthma symptoms.

To be eligible for this study, participants need to be at least 18 years old and have a diagnosis of asthma that isn't well controlled, meaning their symptoms aren't managed effectively with their current medication. They need to be willing to make changes to their diet and be able to provide consent to participate. If you join the study, you will receive support in following the DASH diet and will be monitored for improvements in your asthma and overall well-being. This research could lead to a simple and safe way to help people with asthma manage their condition through dietary changes.

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Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older at study enrollment
• • Diagnosis of asthma with currently prescribed controller therapy (i.e., Step 2 or above) according to the 2020 asthma guideline update (EPR4)
• • Uncontrolled asthma on study screening based on Asthma Control Test (ACT) scores \<20
• • Being able and willing to provide written informed consent and HIPAA authorization
• Exclusion Criteria:
• • Inability to speak, read or understand English sufficiently to provide valid informed consent
• • Primary diagnosis of COPD (emphysema or chronic bronchitis)
• • Previous cardiovascular disease: coronary heart disease (myocardial infarction, angina pectoris, percutaneous coronary intervention, coronary artery bypass graft surgery), cerebrovascular disease (stroke, transient ischemic attack), peripheral vascular disease, heart failure, or aortic aneurysm
• • Diabetes (other than during pregnancy)
• • Diagnosis of cancer (other than non-melanoma skin cancer) within the past year and/or actively receiving cancer treatment
• • Inflammatory bowel disease, colostomy, malabsorption, or major gastrointestinal resection
• • Diagnosis of bipolar or psychotic disorder
• • Hospitalization for psychological or emotional problems within the last 2 years
• • Cognitive impairment based on the Callahan 6-item screener67
• • Terminal illness or in hospice or long-term care
• • Current diet of good quality (DASH concordance index ≥6 out of 9 total)
• • Current/planned participation in another structured program that overtly focuses on diet and nutrition
• • On special diet that precludes changes adherent to the DASH dietary pattern or otherwise unwillingness to modify current diet
• • Current use of prescription or non-prescription weight-loss products and unwillingness to stop taking them for the duration of the study
• • Underweight per body mass index (BMI) below 18.5 kg/m2 based on measured height and weight at study enrollment
• • Actively attempting to lose weight or weight change \>15 lbs during prior 3 months
• • Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)68
• • Current within the past 6-months or former smoker (more than 20-packs of cigarettes in the lifetime, or current smoker)
• • Current or planned pregnancy or currently lactating
• • Planning to move out of the area during the study period
• • Participation in another clinical trial or investigational treatment study
• • Family/household member of an already enrolled participant or of a study team member
• • Investigator discretion for clinical safety or protocol adherence reasons