Intervention to Reduce Dietary Sodium in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.

Detailed Description
-----------------
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 personal digital assistant (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 IDWG-A 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 (SCT). 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.

Official Title
-----------------
Intervention to Reduce Dietary Sodium in Hemodialysis

Conditions
-----------------
Renal Dialysis

Intervention / Treatment
-----------------
* Behavioral: SCT-based behavioral intervention
* Behavioral: Attention Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with end stage renal disease (ESRD) who are 18 years of age or older, Individuals who are literate, Community-dwelling adults who have been receiving maintenance dialysis for at least 3 months. Exclusion Criteria: Individuals who cannot read or write, Individuals who do not speak English, Individuals who plan to move out of the area or change dialysis centers within the next 6 months, Individuals who have a life expectancy of less than 12 months, Individuals who are scheduled for a living donor transplant, Individuals who cannot see the PDA screen or use the stylus to make food selections from the PDA screen, or Individuals who live in an institutional setting in which they would have limited control over their dietary intake.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCT-based behavioral intervention<br>Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring. | Behavioral: SCT-based behavioral intervention<br>* Intervention group continues to receive routine dialysis care. The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targeted counseling and engaged the participant in problem solving around dietary issues.<br>|
| Active Comparator: Attention control<br>Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period. | Behavioral: Attention Control<br>* Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Specific Interdialytic Weight Gain (Baseline) | Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement. | Baseline | 
| Time Specific Interdialytic Weight Gain (8 Weeks) | Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point. | 8 weeks | 
| Time Specific Interdialytic Weight Gain (12 Weeks) | Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point. | 12 weeks | 
| Time Specific Interdialytic Weight Gain (16 Weeks) | Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point. | 16 weeks | 
| Time Specific Dietary Sodium Intake (Baseline) | Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. | Baseline | 
| Time Specific Dietary Sodium Intake (8 Weeks) | Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. | 8 weeks | 
| Time Specific Dietary Sodium Intake (16 Weeks) | Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. | 16 weeks | 
| Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) | Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. The difference between measurement time points was determined. | Baseline to 8 weeks | 
| Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) | Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. | Baseline to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intervention studies, Computers, handheld, Randomized controlled trial, Sodium, dietary