ACTIVE_NOT_RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-03-09
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05251402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older at study enrollment
  2. * Diagnosis of asthma with currently prescribed controller therapy (i.e., Step 2 or above) according to the 2020 asthma guideline update (EPR4)
  3. * Uncontrolled asthma on study screening based on Asthma Control Test (ACT) scores \<20
  4. * Being able and willing to provide written informed consent and HIPAA authorization
  1. * Inability to speak, read or understand English sufficiently to provide valid informed consent
  2. * Primary diagnosis of COPD (emphysema or chronic bronchitis)
  3. * 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
  4. * Diabetes (other than during pregnancy)
  5. * Diagnosis of cancer (other than non-melanoma skin cancer) within the past year and/or actively receiving cancer treatment
  6. * Inflammatory bowel disease, colostomy, malabsorption, or major gastrointestinal resection
  7. * Diagnosis of bipolar or psychotic disorder
  8. * Hospitalization for psychological or emotional problems within the last 2 years
  9. * Cognitive impairment based on the Callahan 6-item screener67
  10. * Terminal illness or in hospice or long-term care
  11. * Current diet of good quality (DASH concordance index ≥6 out of 9 total)
  12. * Current/planned participation in another structured program that overtly focuses on diet and nutrition
  13. * On special diet that precludes changes adherent to the DASH dietary pattern or otherwise unwillingness to modify current diet
  14. * Current use of prescription or non-prescription weight-loss products and unwillingness to stop taking them for the duration of the study
  15. * Underweight per body mass index (BMI) below 18.5 kg/m2 based on measured height and weight at study enrollment
  16. * Actively attempting to lose weight or weight change \>15 lbs during prior 3 months
  17. * Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID)68
  18. * Current within the past 6-months or former smoker (more than 20-packs of cigarettes in the lifetime, or current smoker)
  19. * Current or planned pregnancy or currently lactating
  20. * Planning to move out of the area during the study period
  21. * Participation in another clinical trial or investigational treatment study
  22. * Family/household member of an already enrolled participant or of a study team member
  23. * Investigator discretion for clinical safety or protocol adherence reasons

Contacts and Locations

Principal Investigator

Jun Ma, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

Department of Medicine
Chicago, Illinois, 60608
United States
UIC CCTS Clinical Research Center
Chicago, Illinois, 60608
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-09
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-03-09
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma