Intervention to Reduce Dietary Sodium in Hemodialysis

描述(申请人提供)：心血管疾病是血液透析(HD)患者最常见的死亡原因。大多数HD患者都有左心室肥厚(LVH)，这是这一人群死亡的重要预测因素。左心室肥厚与细胞外体积扩张和高血压有关，两者都容易受到饮食钠限制的影响。然而，众所周知，饮食改变很难实现和持续。对于HD来说，控制饮食中的钠尤其困难，因为许多食物都含有天然的高钠，而且大多数预制/预先包装的食物都添加了大量的钠来提高口感和保质期。能有效减少HD患者膳食钠摄入量的行为方法研究非常有限。这项研究的目的是在200名HD患者的随机临床试验中，测试行为干预结合基于PDA的饮食自我监测，以提高对饮食钠限制的依从性。具体而言，调查者将：(A)评估干预对平均每日透析间期体重增加(IDWGA)的影响。(B)审查干预措施对自我报告的膳食钠摄入量的影响。研究假设是，与对照组相比，干预组将：(1)在4个月的干预期间，IDWGA在统计学上显著下降，(2)饮食钠摄入量下降更大。其次，研究人员将探讨干预措施对以下方面的影响：(A)透析前脉压和平均动脉压，(B)血液透析饮食自我效能，(C)透析中和透析后症状以及与健康相关的一般生活质量。此外，调查人员将通过定性方法确定坚持HD饮食方案的障碍/促进者的特征以及患者对干预的体验。干预的理论基础是社会认知理论。干预背景下的自我监测使用BalanceLog软件作为基于PDA的饮食记录进行操作。随机接受注意力控制的参与者将接受计算机化的饮食教育。在为期4个月的研究结束后，注意力控制参与者将获得干预的简明版本。IDWGA、脉压和平均动脉压之间的差异将使用随机截距线性回归模型来检验。将在基线、6周和4个月评估自我报告的膳食钠、自我效能、症状和生活质量，并使用GEE进行重复测量建模来检验差异。将对叙事数据进行定性分析。公共卫生相关性：终末期肾病(ESRD)的患病率呈指数级增长，主要原因是2型糖尿病、肥胖症和高血压患者的数量不断增加，以及人口老龄化。终末期肾病最常见的治疗方法是血液透析(HD)，这是一种需要严格限制饮食钠以防止液体超负荷的方案。通过这项研究，研究人员将评估行为干预的有效性，其中包括基于技术的饮食自我监控，以帮助HD患者限制他们的饮食钠摄入量。

DESCRIPTION (provided by applicant): Cardiovascular disease is the single most common cause of death in hemodialysis (HD) patients. Most HD patients have left ventricular hypertrophy (LVH), a significant predictor of death in this population. LVH is related to extra cellular volume expansion and hypertension, both of which are amenable to dietary sodium restriction. However, dietary change is widely known to be difficult to achieve and sustain. Controlling dietary sodium is particularly difficult for HD because many foods are naturally high in sodium, and most prepared/prepackaged foods have significant amounts of sodium added to enhance taste and shelf-life. Research on behavioral methods that are effective in reducing dietary sodium intake in HD is very limited. The purpose of this study is to test, in a randomized clinical trial of 200 HD patients, a behavioral intervention, paired with PDA-based dietary self-monitoring, to enhance adherence to dietary sodium restrictions. Specifically the investigators will: (a) Assess the impact of the intervention on average daily interdialytic weight gains (IDWGA). (b) Examine the impact of the intervention on self-reported dietary sodium intake. The study hypotheses are that compared to the control group, the intervention group will: (1) demonstrate a statistically significant decline in IDWGA over the 4-month intervention period, and (2) experience a greater decline in dietary sodium intake. Secondarily, the investigators will explore the impact of the intervention on: (a) pre-dialysis pulse pressure and mean arterial blood pressure, (b) hemodialysis dietary self-efficacy, and (c) intradialytic and postdialytic symptoms and general health-related quality of life. In addition, the investigators will characterize the barriers/facilitators to adherence to the HD dietary regimen and patient experience of the intervention through the use of qualitative methods. The intervention is based on Social Cognitive Theory. Self-monitoring within the context of the intervention is operationalized as PDA-based dietary recording using BalanceLog software. Participants randomized to the attention control will receive computerized dietary education. Attention control participants will be offered an abbreviated version of the intervention after the 4-month study period concludes. Differences in IDWGA, pulse pressure, and mean arterial pressure will be examined using a random intercept linear regression modeling. Self-reported dietary sodium, self-efficacy, symptoms, and quality of life will be assessed at baseline, 6 weeks, and 4 month and differences will be examined using repeated measures modeling using GEE. Qualitative analysis of narrative data will be performed. PUBLIC HEALTH RELEVANCE: The prevalence of end-stage renal disease (ESRD) is growing exponentially, largely due to the growing number of people with type 2 diabetes, obesity, and hypertension, and the aging of the population. The most common treatment approach for ESRD is hemodialysis (HD), a regimen which requires strict dietary sodium limitations to prevent fluid volume overload. With this study the investigators will evaluate the effectiveness of a behavioral intervention that involves technology- based dietary self-monitoring, for helping those on HD limit their dietary sodium intake.