DASH Diet + Patient Education for Asthma
(ALOHA Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: University of Illinois at Chicago
Must be taking: Controller therapy
Must not be taking: Weight-loss products
Disqualifiers: COPD, Cardiovascular disease, Diabetes, Cancer, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require you to stop using any prescription or non-prescription weight-loss products for the duration of the study.
What data supports the effectiveness of the DASH Diet as a treatment for asthma?
Research suggests that the DASH Diet, which is known for improving heart health, may also help people with asthma by improving diet quality and asthma control. A study showed potential benefits of this diet for adults with uncontrolled asthma, indicating it could be a helpful addition to asthma management.
12345Is the DASH diet safe for humans?
The DASH diet is generally safe for most people and is recommended by health guidelines. However, caution is advised for individuals with chronic kidney or liver disease, and those on certain medications, as modifications may be needed.
12678How is the DASH Diet treatment different from other asthma treatments?
The DASH Diet treatment for asthma is unique because it focuses on improving diet quality by promoting high intake of fruits, vegetables, and lean proteins while reducing salt and unhealthy fats, which is different from traditional asthma treatments that typically involve medications. This approach aims to improve asthma control by addressing dietary risk factors rather than relying solely on medication.
127910Eligibility Criteria
Adults over 18 with uncontrolled asthma, as indicated by an Asthma Control Test score below 20, and on prescribed controller therapy can join. They must understand English well enough for informed consent. Exclusions include recent cancer treatment, COPD diagnosis, diabetes outside pregnancy, significant weight change or dieting attempts recently, certain cardiovascular diseases, smoking history or current use, cognitive impairments or severe mental health issues within the last two years.Inclusion Criteria
I am 18 years old or older.
I have asthma and am on a prescribed treatment plan.
My asthma is not well-controlled, with an ACT score below 20.
+1 more
Exclusion Criteria
I have smoked more than 20 packs of cigarettes in my lifetime or am currently smoking.
Planning to move out of the area during the study period
I have diabetes not related to pregnancy.
+20 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one of two asthma care programs, including patient education and potentially nutrition counseling, over a 1-year period
52 weeks
3 individual sessions, 8 group sessions, 11 phone consultations
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
4 visits (in-person) at baseline, 3 months, 6 months, and 12 months
Participant Groups
The ALOHA trial is testing if a DASH dietary intervention improves quality of life in adults with uncontrolled asthma compared to standard patient education. The DASH diet is known to help with high blood pressure but its effects on asthma are unknown. Group B receives nutrition counseling plus education; Group A gets only education.
2Treatment groups
Active Control
Group I: Group B - Patient Education with Nutrition CounselingActive Control1 Intervention
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.
Group II: Group A - Patinet EducationActive Control1 Intervention
If you are assigned to this group, you will receive education on asthma and health from an ALOHA health coach.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Department of MedicineChicago, IL
UIC CCTS Clinical Research CenterChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
University of Newcastle, AustraliaCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
University of VermontCollaborator
University of ChicagoCollaborator
Stanford UniversityCollaborator
References
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. [2023]Poor diet quality is an important risk factor for increased asthma prevalence and poor asthma control. To address the question of whether adults with asthma can benefit from following a healthy diet, this trial will test the efficacy and mechanisms of action of a behavioral intervention promoting the Dietary Approaches to Stop Hypertension (DASH) dietary pattern with sodium reduction among patients with uncontrolled asthma.
Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma. [2018]Rigorous research on the benefit of healthy eating patterns for asthma control is lacking.We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores
Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. [2021]To describe an intervention among overweight and obese hypertensive patients, encouraging Dietary Approaches to Stop Hypertension (DASH) diet and lifestyle changes, designed and led by a primary care nurse practitioner (NP).
Psychometric Validation of a Brief Self-report Measure of Diet Quality: The DASH-Q. [2018]The Dietary Approaches to Stop Hypertension (DASH) diet is recommended for primary and secondary prevention of cardiovascular chronic diseases. This study describes the development, internal consistency, and validation (predictive and convergent) of a population-based, self-report measure (the DASH Quality [DASH-Q]) to assess adherence to the DASH diet among adults.
Acceptability and feasibility of the 'DASH for Asthma' intervention in a randomized controlled trial pilot study. [2023]'DASH for Asthma' (n 90) was a 6-month randomized controlled trial that demonstrated potential benefits of a DASH (Dietary Approaches to Stop Hypertension) behavioural intervention for improving diet quality and asthma control by comparing intervention to usual care in adults with uncontrolled asthma. The present study examined acceptability and feasibility of the intervention from the perspective of intervention participants and lifestyle coaches.
Improved diet quality is associated with decreased concentrations of inflammatory markers in adults with uncontrolled asthma. [2023]Asthma has become one of the major public health challenges, and recent studies show promising clinical benefits of dietary interventions, such as the Dietary Approaches to Stop Hypertension (DASH) diet.
The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]The Dietary Approaches to Stop Hypertension (DASH) trial showed that a diet rich in fruits, vegetables, low-fat dairy products with reduced total and saturated fat, cholesterol, and sugar-sweetened products effectively lowers blood pressure in individuals with prehypertension and stage I hypertension. Limited evidence is available on the safety and efficacy of the DASH eating pattern in special patient populations that were excluded from the trial. Caution should be exercised before initiating the DASH diet in patients with chronic kidney disease, chronic liver disease, and those who are prescribed renin-angiotensin-aldosterone system antagonist, but these conditions are not strict contraindications to DASH. Modifications to the DASH diet may be necessary to facilitate its use in patients with chronic heart failure, uncontrolled diabetes mellitus type II, lactose intolerance, and celiac disease. In general, the DASH diet can be adopted by most patient populations and initiated simultaneously with medication therapy and other lifestyle interventions.
DASH Dietary Pattern and Cardiometabolic Outcomes: An Umbrella Review of Systematic Reviews and Meta-Analyses. [2020]The Dietary Approaches to Stop Hypertension (DASH) dietary pattern, which emphasizes fruit, vegetables, fat-free/low-fat dairy, whole grains, nuts and legumes, and limits saturated fat, cholesterol, red and processed meats, sweets, added sugars, salt and sugar-sweetened beverages, is widely recommended by international diabetes and heart association guidelines.
The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]The dietary approaches to stop hypertension (DASH) encourages high fruit, vegetable, and lean protein consumption and low salt, red meat, and fat intake to prevent or treat hypertension. However, besides hypertension, adherence to this diet has been shown to decrease other cardiovascular risk factors.
Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. [2022]Although the Dietary Approaches to Stop Hypertension (DASH) diet is an accepted nonpharmacologic treatment for hypertension, little is known about what patient characteristics affect dietary adherence and what level of adherence is needed to reduce blood pressure (BP).