The ALOHA Trial: Addressing Quality of Life, Clinical Outcomes, and Mechanisms in Uncontrolled Asthma Following the DASH Dietary Pattern
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 4
- 主要终点
- Proportion of participants achieving a clinically significant improvement (responders) in asthma-specific quality of life (Aim 1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group B - Patient Education with Nutrition Counseling
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.
干预措施: Group B - Patient Education with Nutrition Counseling (Behavioral)
Group A - Patinet Education
If you are assigned to this group, you will receive education on asthma and health from an ALOHA health coach.
干预措施: Group A - Patient Education (Behavioral)
结局指标
主要结局
Proportion of participants achieving a clinically significant improvement (responders) in asthma-specific quality of life (Aim 1)
时间窗: Baseline, 3 months, 6 months, 12 months
The 15-item Juniper Mini Asthma-Specific Quality of Life Questionnaire (AQLQ) has been shown to have excellent reliability and responsiveness to change in asthma control. It consists of 5 items on symptoms, 4 items on activity limitations, 3 items on emotional function, and 3 items concerning environmental stimuli. Each item is rated on a scale from 1=maximum impairment to 7=no impairment over the last 2 weeks. The overall AQLQ score is an average of the item scores equally weighted. The primary outcome is the percentage of participants achieving the minimal clinically important difference (MCID) of at least a 0.5-point increase in AQLQ scores from baseline to 12 months. The percentages of responders at 3 and 6 months are secondary outcomes.
次要结局
- Level of Pre-bronchodilator measurements of FEV1 (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Count of episodes of poorly controlled asthma (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of asthma-specific quality of life (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of asthma control (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of Pre-bronchodilator measurement of FVC (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Measure overall health-related quality of life(Baseline, 3 months, 6 months, 12 months)
- Level of psychological distress (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Proportion of participants achieving a clinically significant improvement (responders) in asthma control (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of asthma medication adherence (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of Blood pressure (BP) (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of plasma carotenoids (Aim 3)(Baseline, 3 months, 6 months, 12 months)
- Level of Pre-bronchodilator measurements FEV1/FVC (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of sleep disturbance (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Level of PBMC cytokines (Interferon-γ, IL-5, IL-17A, IL-10, IL-1β, IL-6, IL-8, TNFα) (Aim 2)(Baseline, 3 months)
- Level of sleep-related impairment (Aim 1)(Baseline, 3 months, 6 months, 12 months)
- Degree of bronchodilator responsiveness based on pre- and post-bronchodilator percent change in FEV1 (Aim 2)(Baseline, 3 months, 6 months, 12 months)
- Level of diet quality based on the dietary inflammatory index (DII) (Aim 3)(Baseline, 3 months, 6 months, 12 months)
- Level of plasma short chain fatty acids (propionate, butyrate, and acetate) (Aim 2)(Baseline, 3 months)
- Level of diet quality based DASH score (Aim 3)(Baseline, 3 months, 6 months, 12 months)
研究者
Jun Ma
Beth and George Vitoux Professor of Medicine, Department of Medicine, Principal Investigator
University of Illinois at Chicago