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DASH Diet + Patient Education for Asthma (ALOHA Trial)

Phase 2 & 3

Recruiting

Led By Jun Ma, MD, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Current within the past 6-months or former smoker (more than 20-packs of cigarettes in the lifetime, or current smoker)

Diabetes (other than during pregnancy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether the DASH diet can help improve quality of life for adults with uncontrolled asthma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may be minimal and related to changes in eating habits. However specific side effects aren't listed as it's not a drug trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have asthma and am on a prescribed treatment plan.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have diabetes not related to pregnancy.

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I was diagnosed with cancer, excluding non-melanoma skin cancer, within the last year or am currently receiving treatment.

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I have a condition affecting my digestive system, such as inflammatory bowel disease, or I've had major surgery on it.

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I have been diagnosed with bipolar or psychotic disorder.

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I have been diagnosed with COPD.

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I am not willing to stop taking weight-loss products during the study.

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I have had heart or blood vessel problems, including heart attack, stroke, or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Count of episodes of poorly controlled asthma (Aim 1)

Degree of bronchodilator responsiveness based on pre- and post-bronchodilator percent change in FEV1 (Aim 2)

Level of Blood pressure (BP) (Aim 1)

+16 more

Other study objectives

Level of patient activation

Level of self-efficacy for dietary change

Level of social support for dietary change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Group B - Patient Education with Nutrition CounselingActive Control1 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 EducationActive Control1 Intervention

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

0 / 11Eligibility criteria met