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ACTIVE NOT RECRUITING

NCT05251402

PHASE2/PHASE3

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

Sponsor: University of Illinois at Chicago

View on ClinicalTrials.gov

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.

Official title: The ALOHA Trial: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

323

Start Date

2022-03-09

Completion Date

2026-09-01

Last Updated

2025-06-19

Healthy Volunteers

Conditions

Asthma

Interventions

BEHAVIORAL

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.

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.

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

Locations (2)

Department of Medicine

Chicago, Illinois, United States

UIC CCTS Clinical Research Center