Improving asthma management through a healthy diet
The ALOHA Trial: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
This study is testing if a healthy diet can help adults with uncontrolled asthma feel better and improve their quality of life.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05251402 on ClinicalTrials.gov |
What this trial studies
The ALOHA trial aims to evaluate the effectiveness of the DASH dietary pattern in improving quality of life and clinical outcomes for adults with uncontrolled asthma. Participants will be randomly assigned to one of two asthma care programs: one focusing solely on patient education and the other combining education with nutrition counseling from a registered dietitian. Over the course of a year, participants will engage in individual and group sessions, as well as phone consultations, to support their asthma management. The primary outcome will be assessed through asthma-specific quality of life measurements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of uncontrolled asthma currently on prescribed controller therapy.
Not a fit: Patients with primary diagnoses of COPD, significant cardiovascular disease, diabetes, or recent cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a practical and safe dietary approach to improve asthma management and quality of life for patients.
How similar studies have performed: Previous studies have shown promising results for dietary interventions in managing chronic conditions, suggesting potential for success in this novel approach for asthma.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Department of Medicine — Chicago, Illinois, United States (Recruiting)
- UIC CCTS Clinical Research Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jun Ma, MD, PhD — University of Illinois at Chicago
- Study coordinator: Jun Ma, MD, PhD
- Email: maj2015@uic.edu
- Phone: 312-413-9830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.