Intervention to Reduce Dietary Sodium in Hemodialysis

描述（由申请方提供）：心血管疾病是血液透析（HD）患者最常见的单一死亡原因。大多数HD患者有左心室肥大（LVH），这是该人群死亡的重要预测因素。LVH与细胞外体积扩张和高血压有关，这两种情况都适用于饮食钠限制。然而，众所周知，饮食变化难以实现和维持。控制饮食中的钠对HD来说特别困难，因为许多食物天然钠含量很高，大多数预制/预包装食品都添加了大量的钠，以增强味道和保质期。关于有效减少HD患者膳食钠摄入量的行为方法的研究非常有限。本研究的目的是在200例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，研究者将：（a）评估干预对平均每日透析间期体重增加（IDWGA）的影响。(b)检查干预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出现统计学显著下降，（2）膳食钠摄入量下降幅度更大。其次，研究者将探讨干预对以下方面的影响：（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一般健康相关生活质量。此外，研究者将通过使用定性方法描述HD饮食方案依从性的障碍/促进因素和患者的干预经验。干预是基于社会认知理论。在干预的背景下，自我监测是可操作的PDA为基础的饮食记录使用BalanceLog软件。被随机分配到注意力控制组的参与者将接受计算机化的饮食教育。在4个月的研究期结束后，将向注意力控制参与者提供干预的简化版本。将使用随机截距线性回归模型检查IDWGA、脉压和平均动脉压的差异。将在基线、6周和4个月时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重复测量建模检查差异。将对叙述性数据进行定性分析。公共卫生相关性：终末期肾病（ESRD）的患病率呈指数级增长，主要是由于2型糖尿病、肥胖和高血压患者数量的增加以及人口老龄化。ESRD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容量超负荷的方案。通过这项研究，研究人员将评估行为干预的有效性，该干预涉及基于技术的饮食自我监测，以帮助HD患者限制饮食钠摄入量。

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.