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

NCT05251402 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2025-06-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER
  • University of Vermont

    collaborator OTHER
  • University of Newcastle, Australia

    collaborator OTHER
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of Chicago

    collaborator OTHER
  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Jun Ma, MD, PhD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2026-06-01
Completion
2026-09-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251402 on ClinicalTrials.gov