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: 10295652
• 负责人: Jun Ma
• 金额: $ 82.61万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10295652
• 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; Lung; 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; 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; 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.

项目摘要 哮喘是气道的慢性炎症性疾病。哮喘患病率在 美国，有1900万成年人报告目前的哮喘，其中62％的哮喘无法控制。贫穷的 饮食质量是在这种令人震惊的趋势中实施的重要危险因素，这是典型的西方饮食特征 加工，能量密集，营养缺乏的食物，促进促炎的宿主环境。饮食质量 哮喘是新兴领域的研究领域；很少有干预试验研究了健康的饮食模式 患有哮喘的成年人，没有足够的动力来确定效率，而潜在的机制则很差 理解齿。目的：为了填补这一空白，当前的2期，里程碑驱动的Aloha试验将严格 评估行为干预的效率和机制，以促进饮食方法停止 高血压（破折号）。这种行为干预显示了有希望的结果，这是成年人的试点试验 不受控制的哮喘。方法：R61阶段（1年）将着重于完成试用计划和准备 并开始早期入学；在R33阶段（4年）中，我们将在12中进行2臂随机临床试验 月份。在标准控制器治疗上患有不受控制的哮喘（n = 320）的成年人将是同样随机的，并且 在基线（0），3、6和12个月时进行评估。控制和干预组将在 每次会议的数量，频率和格式在12个月内，每个会话的长度与 内容交付。控制参与者将接受有关肺部健康，哮喘和其他一般健康的教育 使用美国肺协会和上调材料的主题。干预小组将获得相同的 健康教育和材料除了行为咨询之外。中央假设：与 仅限教育控制，破折号的行为干预将导致更多的参与者 在特定于哮喘的生活质量（主要结果）和 相关的哮喘和非哮喘结局的改善将大大改善，这将是机械上的 与改善饮食质量有关。具体目的：首先，确定主要结果的干预效率 12个月的哮喘特异性生活质量和次要结果的临床显着改善 （哮喘控制，肺功能，仿制药，血压，心理健康，睡眠健康）。第二，到 检查对代谢组学的干预作用（循环短链脂肪酸：丙酸酯，丁酸酯， 乙酸盐），免疫响应（干扰素 - 伽马，IL-5，IL-17A，IL-10，IL-10，IL-1β，IL-6，IL-6，IL-8，TNFα）和生理学 （支气管扩张剂的反应能力）哮喘的生物标志物。第三，检查干预对自我的影响 饮食质量的报告和客观指数（仪表板评分，饮食炎症指数，血清类胡萝卜素）。我们 还将对饮食质量，生物标志物和哮喘结局联系的因果中介进行探索性分析 以及通过性别和其他生物学变量（哮喘发作的年龄，特应性的年龄）进行的效果修饰。影响：这个 试验具有较高的潜力，可以提高哮喘饮食质量的临床和机械理解。

项目成果

Erratum to "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" [Contemporary Clinical Trials 131 (2023) 107274].

“DASH 饮食模式对哮喘不受控制的成人临床结果和生活质量的影响：ALOHA 试验的设计和方法”[当代临床试验 131 (2023) 107274] 的勘误。

• DOI: 10.1016/j.cct.2023.107373
• 发表时间: 2024
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Nyenhuis,SM;Dixon,AE;Wood,L;Lv,N;Wittels,NE;Ronneberg,CR;Xiao,L;Dosala,S;Marroquin,A;Barve,A;Harmon,W;Poynter,ME;Parikh,A;CamargoJr,CA;Appel,LJ;Ma,J
• 通讯作者: Ma,J

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.

DASH 饮食模式对哮喘未受控制的成人临床结果和生活质量的影响：ALOHA 试验的设计和方法。

• DOI: 10.1016/j.cct.2023.107274
• 发表时间: 2023
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Nyenhuis,SM;Dixon,A;Wood,L;Lv,N;Wittels,N;Ronneberg,CR;Xiao,L;Dosala,S;Marroquin,A;Barve,A;Harmon,W;Poynter,M;Parikh,A;CamargoJr,CA;Appel,L;Ma,J
• 通讯作者: Ma,J