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

NCT ID: NCT05251402

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2026-09-01

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 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.

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 either 1 of the 2 asthma care programs

Both asthma care programs are for a year and offer patient education on asthma and health. In both asthma care programs, you will receive fact-based patient information on asthma and health. Additionally, in one of the programs, a registered dietitian will also provide nutrition counseling on how to follow the USDA recommended DASH diet. Both asthma care programs offer 3 individual sessions, 8 group sessions, and 11 phone consultations. Your first individual session will be in-person with a trained health coach on the ALOHA team. The remaining 2 individual sessions will be either in-person or remote, depending on what you and your coach decide. You will also attend the first 2 (of 8) group sessions in-person to build connection with your coach and peer participants in the group. You and your coach will then decide whether you should attend the remaining group sessions in-person or remotely. Your ALOHA health coach will offer you continued support by phone until you complete your 1-year program.

Study Visits at UIC: Irrespective of your asthma care group, all participants will be expected to visit UIC Study site 4 times over the next year, initially and then at 3 months, at 6 months, and finally at one year. You will meet with an ALOHA study coordinator for 2 hours at the initial and final visits and for 1 hour at 3 and 6 months. Before each visit, you will complete online surveys about your health and phone interviews about your diet. At each visit, you will complete a breathing test, a blood draw, a physical exam, and questions about your asthma, diet and exercise habits, use of asthma medications and dietary supplements.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A - Patinet Education

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

Group Type: ACTIVE_COMPARATOR

Group A - Patient Education

Intervention Type: BEHAVIORAL

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

• In months 1-3, you will attend 3 individual and 8 group sessions. Individual sessions will last ~15 minutes and the first one will be in-person. Group sessions will last ~30 minutes and the first 2 of the 8 will be in person. You and your coach will determine if you may attend the remaining individual and group sessions remotely instead, via Zoom or phone. The purpose of these sessions is to provide you with general information about respiratory health topics, including recommendations for asthma care, inhaler use, and lung health.
• In months 4-12, you will complete 11 phone check-ins for ~10 minutes each. The purpose of these phone calls is to provide you with ongoing support and discuss health topics of your choice.

Group B - Patient Education with Nutrition Counseling

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 Type: ACTIVE_COMPARATOR

Group B - Patient Education with Nutrition Counseling

Intervention Type: BEHAVIORAL

If you are assigned to this group, you will receive the same patient education as Group A. In addition, you will receive nutrition counseling from your health coach who is a registered dietitian.

• In months 1-3, the duration of the sessions will increase to ~30 minutes each for the 3 individual sessions and to ~60 minutes each for the 8 group sessions. This is because in addition to providing the same information on asthma and health as in Group A, your health coach will also counsel you on how to follow the DASH diet by adopting effective behavior change techniques such as goal setting, self-monitoring, and problem solving.
• In months 4-12, your health coach will review your progress, provide you with personalized feedback, assist you in problem solving as you continue to work towards the DASH dietary goals, and help you maintain the changes you have made over the long term.

Interventions

Group A - Patient Education

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

• In months 1-3, you will attend 3 individual and 8 group sessions. Individual sessions will last ~15 minutes and the first one will be in-person. Group sessions will last ~30 minutes and the first 2 of the 8 will be in person. You and your coach will determine if you may attend the remaining individual and group sessions remotely instead, via Zoom or phone. The purpose of these sessions is to provide you with general information about respiratory health topics, including recommendations for asthma care, inhaler use, and lung health.
• In months 4-12, you will complete 11 phone check-ins for ~10 minutes each. The purpose of these phone calls is to provide you with ongoing support and discuss health topics of your choice.

Intervention Type: BEHAVIORAL

Group B - Patient Education with Nutrition Counseling

If you are assigned to this group, you will receive the same patient education as Group A. In addition, you will receive nutrition counseling from your health coach who is a registered dietitian.

• In months 1-3, the duration of the sessions will increase to ~30 minutes each for the 3 individual sessions and to ~60 minutes each for the 8 group sessions. This is because in addition to providing the same information on asthma and health as in Group A, your health coach will also counsel you on how to follow the DASH diet by adopting effective behavior change techniques such as goal setting, self-monitoring, and problem solving.
• In months 4-12, your health coach will review your progress, provide you with personalized feedback, assist you in problem solving as you continue to work towards the DASH dietary goals, and help you maintain the changes you have made over the long term.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: collaborator

University of Newcastle, Australia

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Jun Ma

Beth and George Vitoux Professor of Medicine, Department of Medicine, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Ma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Department of Medicine

Chicago, Illinois, United States

UIC CCTS Clinical Research Center

Chicago, Illinois, United States

Countries

United States

References

Nyenhuis SM, Dixon A, Wood L, Lv N, Wittels N, Ronneberg CR, Xiao L, Dosala S, Marroquin A, Barve A, Harmon W, Poynter M, Parikh A, Camargo CA Jr, Appel L, Ma J. The effects of the DASH dietary pattern on clinical outcomes and quality of life in adults with uncontrolled asthma: Design and methods of the ALOHA Trial. Contemp Clin Trials. 2023 Aug;131:107274. doi: 10.1016/j.cct.2023.107274. Epub 2023 Jun 26.

Reference Type: DERIVED

PMID: 37380019 (View on PubMed)

Other Identifiers

R61HL155160

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021-1375

Identifier Type: -

Identifier Source: org_study_id