Clinical trial NCT05251402: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
Official title: The ALOHA Trial: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Asthma
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Stanford University
name: University of Vermont
name: University of Newcastle, Australia
name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Chicago
First posted: 2022-02-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of participants achieving a clinically significant improvement (responders) in asthma-specific quality of life (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Level of asthma-specific quality of life (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of asthma control (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Proportion of participants achieving a clinically significant improvement (responders) in asthma control (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of Pre-bronchodilator measurements of FEV1 (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of Pre-bronchodilator measurement of FVC (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of Pre-bronchodilator measurements FEV1/FVC (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of asthma medication adherence (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Count of episodes of poorly controlled asthma (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Measure overall health-related quality of life
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of Blood pressure (BP) (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of psychological distress (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of sleep disturbance (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of sleep-related impairment (Aim 1)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Degree of bronchodilator responsiveness based on pre- and post-bronchodilator percent change in FEV1 (Aim 2)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of plasma short chain fatty acids (propionate, butyrate, and acetate) (Aim 2)
timeFrame: Baseline, 3 months
measure: Level of PBMC cytokines (Interferon-γ, IL-5, IL-17A, IL-10, IL-1β, IL-6, IL-8, TNFα) (Aim 2)
timeFrame: Baseline, 3 months
measure: Level of diet quality based DASH score (Aim 3)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of diet quality based on the dietary inflammatory index (DII) (Aim 3)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of plasma carotenoids (Aim 3)
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
measure: Level of self-efficacy for dietary change
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of social support for dietary change
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Level of patient activation
timeFrame: Baseline, 3 months, 6 months, 12 months
Locations:
city: Chicago
country: United States
facility: Department of Medicine
state: Illinois
city: Chicago
country: United States
facility: UIC CCTS Clinical Research Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jun Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: