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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 12 months
Awards & highlights
ALOHA Trial 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.Check my eligibility
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.See study design
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.
ALOHA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ALOHA Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving a clinically significant improvement (responders) in asthma-specific quality of life (Aim 1)
Secondary outcome measures
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 moreOther outcome measures
Level of patient activation
Level of self-efficacy for dietary change
Level of social support for dietary change
ALOHA 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.
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
611 Previous Clinical Trials
1,560,245 Total Patients Enrolled
6 Trials studying Asthma
7,534 Patients Enrolled for Asthma
University of Newcastle, AustraliaOTHER
10 Previous Clinical Trials
3,379 Total Patients Enrolled
2 Trials studying Asthma
240 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,846 Previous Clinical Trials
47,817,983 Total Patients Enrolled
278 Trials studying Asthma
112,701 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have smoked more than 20 packs of cigarettes in my lifetime or am currently smoking.I am 18 years old or older.I have diabetes not related to pregnancy.I was diagnosed with cancer, excluding non-melanoma skin cancer, within the last year or am currently receiving treatment.I have asthma and am on a prescribed treatment plan.I have a condition affecting my digestive system, such as inflammatory bowel disease, or I've had major surgery on it.I have been diagnosed with bipolar or psychotic disorder.You have a problem with alcohol or drugs.You have a serious illness and are receiving long-term care or hospice care.You are currently following a healthy diet with a score of at least 6 out of 9.You are currently in or planning to join a specific program that focuses on diet and nutrition.You are too thin based on your height and weight.I have been diagnosed with COPD.My asthma is not well-controlled, with an ACT score below 20.You have been trying to lose weight or have lost more than 15 pounds in the last 3 months.I am not willing to stop taking weight-loss products during the study.I have had heart or blood vessel problems, including heart attack, stroke, or surgery.You have trouble remembering things or thinking clearly, as shown by a special test called the Callahan 6-item screener.
Research Study Groups:
This trial has the following groups:- Group 1: Group B - Patient Education with Nutrition Counseling
- Group 2: Group A - Patinet Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the magnitude of participants enrolled in this experimental endeavor?
"Affirmative. The clinical trial is still recruiting, as evidenced by the data posted on clinicaltrials.gov. It was initially launched on March 9th 2022 and has since been updated May 26th of that same year. This medical experiment seeks to recruit 320 participants from two separate sites."
Answered by AI
Are there still opportunities for participation in this experiment?
"According to clinicaltrials.gov, this experiment is presently in pursuit of participants and was initially published on March 9th 2022; the particulars were last modified on May 26th 2022."
Answered by AI
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