CompletedPhase 2/3

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

United States323 participantsStarted 2022-03-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested the DASH diet — which is typically recommended for blood pressure — in people with uncontrolled asthma, so could following the DASH diet actually help manage my asthma symptoms, and is that something worth trying alongside my current medications?
2The trial is now completed, so has the data been published yet, and if so, what did it show about how many people actually saw a meaningful improvement in their asthma-related quality of life?
3Since this was a Phase 2/3 study, what does that mean for how confident we can be in the safety and effectiveness of using a dietary approach for asthma — is the evidence strong enough to act on it, or is it still preliminary?
4My asthma is currently uncontrolled, so before considering a dietary intervention like DASH, should I first make sure I've tried all the standard medical treatments available to me, like controller inhalers or biologics?
5How realistic would it be for me to follow the DASH dietary pattern given my daily routine and food budget, and would you be able to refer me to a dietitian who could help me figure that out?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants achieving a clinically significant improvement (responders) in asthma-specific quality of life (Aim 1)

Timeframe: Baseline, 3 months, 6 months, 12 months

Trial details

NCT IDNCT05251402

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-24

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