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

NCT05251402 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2021-1375R61HL155160
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

  The 15-item Juniper Mini Asthma-Specific Quality of Life Questionnaire (AQLQ) has been shown to have excellent reliability and responsiveness to change in asthma control. It consists of 5 items on symptoms, 4 items on activity limitations, 3 items on emotional function, and 3 items concerning environmental stimuli. Each item is rated on a scale from 1=maximum impairment to 7=no impairment over the last 2 weeks. The overall AQLQ score is an average of the item scores equally weighted. The primary outcome is the percentage of participants achieving the minimal clinically important difference (MCID) of at least a 0.5-point increase in AQLQ scores from baseline to 12 months. The percentages of responders at 3 and 6 months are secondary outcomes.

  Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (19)

• Level of asthma-specific quality of life (Aim 1)

  Baseline, 3 months, 6 months, 12 months

• Level of asthma control (Aim 1)

  Baseline, 3 months, 6 months, 12 months

• Proportion of participants achieving a clinically significant improvement (responders) in asthma control (Aim 1)

  Baseline, 3 months, 6 months, 12 months

• Level of Pre-bronchodilator measurements of FEV1 (Aim 1)

  Baseline, 3 months, 6 months, 12 months

• Level of Pre-bronchodilator measurement of FVC (Aim 1)

  Baseline, 3 months, 6 months, 12 months

Other Outcomes (3)

• Level of self-efficacy for dietary change

  Baseline, 3 months, 6 months, 12 months

• Level of social support for dietary change

  Baseline, 3 months, 6 months, 12 months

• Level of patient activation

  Baseline, 3 months, 6 months, 12 months

Study Arms (2)

Group A - Patinet Education

ACTIVE COMPARATOR

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

Behavioral: Group A - Patient Education

Group B - Patient Education with Nutrition Counseling

ACTIVE COMPARATOR

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.

Behavioral: Group B - Patient Education with Nutrition Counseling

Interventions

Group A - Patient Education 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 A - Patinet Education

Group B - Patient Education with Nutrition Counseling 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.

Group B - Patient Education with Nutrition Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Stanford University: collaborator
• University of Vermont: collaborator
• University of Newcastle, Australia: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Chicago: collaborator

Study Sites (2)

Department of Medicine

Chicago, Illinois, 60608, United States

Location

UIC CCTS Clinical Research Center

Chicago, Illinois, 60608, United States

Location

Related Publications (1)

• 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.

  PMID: 37380019 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jun Ma, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beth and George Vitoux Professor of Medicine, Department of Medicine, Principal Investigator

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 22, 2022
• Study Start: March 9, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (2)