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

ALOHA 试验：按照 DASH 饮食模式解决哮喘失控的生活质量、临床结果和机制

• 批准号: 10515385
• 负责人: Jun Ma
• 金额: $ 79.86万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-20 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10515385
• 关键词: Acetates; Address; Adult; Affect; Age; Airway Disease; American Lung Association; Area; Asthma; Behavior Therapy; Behavioral; Biological; Biological Markers; Blood Pressure; Body Weight Changes; Body Weight decreased; Bronchodilator Agents; Butyrates; Calories; Cardiometabolic Disease; Caring; Carotenoids; Cell physiology; Chicago; Clinical; Clinical Trials; Cohort Studies; Counseling; DASH diet; Data; Diet; Dietary Practices; Disease; Education; Enrollment; Environment; Evaluation; Food; Frequencies; Goals; Health; Health education; Hour; IL8 gene; Immune; Immune response; Immunologic Markers; Inflammatory; Intake; Interferon Type II; Interleukin-1 beta; Interleukin-10; Interleukin-17; Interleukin-5; Interleukin-6; Intervention; Intervention Trial; Length; Life; Link; Measures; Mediation; Mental Health; Modification; Names; National Heart, Lung, and Blood Institute; Natural Immunity; Nutrient; Nutritional; Obesity; Outcome; Participant; Patient Self-Report; Patients; Phase; Physiological; Pilot Projects; Policies; Preparation; Prevalence; Procedures; Process; Production; Property; Propionates; Protocols documentation; Publishing; Pulmonary Function Test/Forced Expiratory Volume 1; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Recommendation; Reporting; Research; Research Priority; Risk; Risk Factors; Role; Serum; Solid; Structure; Symptoms; TNF gene; Therapeutic; Time; Training; Treatment Efficacy; Unhealthy Diet; United States; Volatile Fatty Acids; Wood material; Work; acceptability and feasibility; adaptive immunity; airway inflammation; arm; asthma exacerbation; atopy; base; chronic inflammatory disease; clinically significant; cytokine; dietary; dietary guidelines; disorder control; disorder prevention; efficacy evaluation; efficacy trial; fruits and vegetables; good diet; group intervention; improved; indexing; insight; intervention effect; intervention participants; lung health; metabolomics; novel; patient oriented; pilot trial; primary outcome; pulmonary function; racial and ethnic; response; secondary outcome; sex; sleep health; socioeconomics; systemic inflammatory response; trend; weight maintenance; western diet

PROJECT SUMMARY Asthma is a chronic inflammatory disease of the airways. Asthma prevalence has increased markedly in the United States, with 19 million adults reporting current asthma and 62% of them with uncontrolled asthma. Poor diet quality is an important risk factor implicated in this alarming trend as a typical western diet features processed, energy-dense, nutrient-deficient foods, promoting a proinflammatory host environment. Diet quality in asthma is an emerging area of research; few interventional trials have investigated healthy dietary patterns in adults with asthma, none was adequately powered to determine efficacy, and underlying mechanisms are poorly understood. OBJECTIVE: To fill this gap, the current 2-phase, milestone-driven ALOHA trial will rigorously evaluate the efficacy and mechanisms of a behavioral intervention promoting the Dietary Approaches to Stop Hypertension (DASH). This behavioral intervention showed promising results in a pilot trial among adults with uncontrolled asthma. METHODS: The R61 phase (1 year) will focus on finalizing trial planning and preparation and begin early enrollment; in the R33 phase (4 years) we will conduct a 2-arm randomized clinical trial over 12 months. Adults with uncontrolled asthma (n=320) on standard controller therapy will be equally randomized and assessed at baseline (0), 3, 6 and 12 months. The control and intervention groups will be matched on the number, frequency, and format of sessions over 12 months while the length of each session is proportional to the content delivered. Control participants will receive education on lung health, asthma, and other general health topics using American Lung Association and UpToDate materials. The intervention group will receive the same health education and materials in addition to DASH behavioral counseling. Central hypothesis: Compared with the education-only control, the DASH behavioral intervention will lead to significantly more participants with a clinically significant improvement (responders) in asthma-specific quality of life (primary outcome) and significantly greater improvements in related asthma and non-asthma outcomes, which will be mechanistically linked to improved diet quality. SPECIFIC AIMS: First, to determine intervention efficacy on the primary outcome of clinically significant improvement in asthma-specific quality of life at 12 months and secondary outcomes (asthma control, lung function, generic qualify of life, blood pressure, mental health, sleep health). Second, to examine the intervention effects on metabolomic (circulating short-chain fatty acids: propionate, butyrate, acetate), immune response (interferon-gamma, IL-5, IL-17A, IL-10, IL-1β, IL-6, IL-8, TNFα), and physiologic (bronchodilator responsiveness) biomarkers of asthma. Third, to examine the intervention effects on self- reported and objective indices of diet quality (DASH score, dietary inflammatory index, serum carotenoids). We also will conduct exploratory analyses of causal mediation linking diet quality, biomarkers, and asthma outcomes as well as effect modification by sex and other biological variables (age of asthma onset, atopy). IMPACT: This trial has high potential to advance the clinical and mechanistic understandings of diet quality in asthma.

项目概要 哮喘是一种慢性气道炎症性疾病，哮喘患病率在人群中显着增加。 美国有 1900 万成年人患有哮喘，其中 62% 患有未受控制的哮喘。 作为典型的西方饮食特征，饮食质量是这一令人震惊的趋势所涉及的一个重要风险因素 加工、能量密集、营养缺乏的食品，促进促炎宿主环境的饮食质量。 哮喘是一个新兴的研究领域；很少有干预试验调查了健康饮食模式 患有哮喘的成年人，没有足够的能力来确定疗效，而且潜在的机制也很差 目的：为了填补这一空白，当前的两阶段、里程碑驱动的 ALOHA 试验将严格进行。 评估促进饮食戒烟的行为干预的功效和机制 这种行为干预在针对患有高血压的成年人中进行的一项试点试验中显示出良好的结果。 方法：R61 阶段（1 年）将侧重于最终确定试验计划和准备。 并开始早期入组；在R33阶段（4年），我们将进行超过12年的2臂随机临床试验 接受标准控制治疗但哮喘未得到控制的成人 (n=320) 将被同样随机分组。 对照组和干预组将在基线（0）、3、6和12个月时进行评估。 12 个月内的会议次数、频率和形式，而每次会议的长度与 对照组参与者将接受有关肺部健康、哮喘和其他一般健康的教育。 使用美国肺脏协会和 UpToDate 材料的主题 干预组将收到相同的内容。 除 DASH 行为咨询外的健康教育和材料 中心假设：与相比。 仅教育控制，DASH 行为干预将导致更多的参与者 哮喘特异性生活质量（主要结果）的临床显着改善（有反应者）和 相关哮喘和非哮喘结果的显着改善，这将在机制上 与改善饮食质量相关 具体目标：首先，确定对主要结果的干预效果。 12 个月时哮喘特异性生活质量和次要结局的临床显着改善 （哮喘控制、肺功能、一般生活质量、血压、心理健康、睡眠健康）。 检查对代谢组（循环短链脂肪酸：丙酸、丁酸、 醋酸盐）、免疫反应（干扰素-γ、IL-5、IL-17A、IL-10、IL-1β、IL-6、IL-8、TNFα）和生理学 （支气管扩张剂反应性）哮喘生物标志物第三，检查干预对自我的影响。 饮食质量的报告和客观指标（DASH 评分、饮食炎症指数、血清类胡萝卜素）。 还将对饮食质量、生物标志物和哮喘结果之间的因果关系进行探索性分析 以及性别和其他生物学变量（哮喘发病年龄、特应性）的影响。 该试验具有很大的潜力，可以促进对哮喘饮食质量的临床和机制理解。