Status:
ACTIVE_NOT_RECRUITING
Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Stanford University
University of Vermont
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 s...
Detailed Description
Approximately 320 subjects who are determined fully eligible will be randomly assigned (by chance, like flipping a coin) to participate in intervention Group A or Group B, where you will receive eithe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT05251402
Start Date
March 9 2022
End Date
September 1 2026
Last Update
June 19 2025
Active Locations (2)
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1
Department of Medicine
Chicago, Illinois, United States, 60608
2
UIC CCTS Clinical Research Center
Chicago, Illinois, United States, 60608