Intervention to Reduce Dietary Sodium in Hemodialysis (BalanceWise-HD)

• Change in interdialytic weight gain over time [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Weight gain between all treatments are abstracted from dialysis flow sheets for the 16-week duration of the study.
  
  
• Dietary sodium intake [ Time Frame: baseline ] [ Designated as safety issue: No ]
  Three 24-hour dietary recalls are obtained over a 2 week measurement period (i.e. a 1-week window on either side of the measurement time point), including 1 dialysis weekday, 1 nondialysis weekday, and one nondialysis weekend day. Data are entered into the Nutrition Data System for Research.
  
  
• Dietary sodium intake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  Three 24-hour dietary recalls are obtained over a 2 week measurement period (i.e. a 1-week window on either side of the measurement time point), including 1 dialysis weekday, 1 nondialysis weekday, and one nondialysis weekend day. Data are entered into the Nutrition Data System for Research.
  
  
• Dietary sodium intake [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  Three 24-hour dietary recalls are obtained over a 2 week measurement period (i.e. a 1-week window on either side of the measurement time point), including 1 dialysis weekday, 1 nondialysis weekday, and one nondialysis weekend day. Data are entered into the Nutrition Data System for Research.
  
  

• Blood pressure [ Time Frame: Each dialysis treatment over a 4-month time period ] [ Designated as safety issue: No ]
  Standing and sitting blood pressures are obtained prior to and following each dialysis treatment during the 4-month study period.
  
  
• Self-efficacy for restricting dietary sodium in hemodialysis [ Time Frame: baseline, 8 weeks, and 16 weeks ] [ Designated as safety issue: No ]
  An investigator-developed instrument that measures participants' confidence in their ability to limit their intake of dietary sodium.
  
  
• Hemodialysis symptoms [ Time Frame: Baseline, 8, 12, and 16 weeks ] [ Designated as safety issue: No ]
  Participants describe, on an 11-point severity scale (0=no symptoms, 10=severe symptoms), their experience with 11 symptoms related to fluid volume overload between dialysis treatments.
  
  
• Problems with the dialysis diet [ Time Frame: Baseline, 8 and 16 weeks ] [ Designated as safety issue: No ]
  Using an investigator-developed instrument, participants described the frequency with which they experience common barriers to dietary adherence.
  
  
• Self-rated global health [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  Participants describe. on a 5-point scale (1=excellent to 5=poor) participants rate their level of health.
  
  
• Experience with the hemodialysis diet and intervention [ Time Frame: Baseline, 2 weeks, and 16 weeks ] [ Designated as safety issue: No ]
  Qualitative data interview are obtained eliciting participants' experiences with the hemodialysis diet and their experience with the intervention.
  
  

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 extracellular 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 (IDWG-A). (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 IDWG-A, 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.