BalanceWise-HD: Intervention to Reduce Dietary Sodium in Hemodialysis

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01125202
• Collaborator: University of Iowa (Other), National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 179
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Behavioral: SCT-based behavioral intervention; Behavioral: Attention Control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intervention to Reduce Dietary Sodium in Hemodialysis
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SCT-based behavioral intervention 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; 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.
Active Comparator: Attention control 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; 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.

Outcome Measures

Primary Outcome Measures

1. Time Specific Interdialytic Weight Gain (Baseline) [Baseline]

   Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.

2. Time Specific Interdialytic Weight Gain (8 Weeks) [8 weeks]

   Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.

3. Time Specific Interdialytic Weight Gain (12 Weeks) [12 weeks]

   Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.

4. Time Specific Interdialytic Weight Gain (16 Weeks) [16 weeks]

   Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.

5. Time Specific Dietary Sodium Intake (Baseline) [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.

6. Time Specific Dietary Sodium Intake (8 Weeks) [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.

7. Time Specific Dietary Sodium Intake (16 Weeks) [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.

8. Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) [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.

9. Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• University of Iowa
• National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mary Ann Sevick, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01125202
• Other Study ID Numbers: PRO08040361; R01NR010135
• First Posted: May 18, 2010
• Last Update Posted: Aug 15, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Mary Ann Sevick, Professor, University of Pittsburgh: Intervention studies; Computers, handheld; Randomized controlled trial; Sodium, dietary

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 17 dialysis centers, from the 3 corporate chains, between September 2009 and September 2012. Of the 848 HD patients available, 257 were eligible, 191 consented, 185 provided baseline data, 179 were randomized, and 160 (89.4%) completed the final 16-week measurement assessment.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Period Title: Overall Study
STARTED	93	86
COMPLETED	81	79
NOT COMPLETED	12	7

Baseline Characteristics

Arm/Group Title	Intervention	Attention Control	Total
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.	Total of all reporting groups
Overall Participants	93	85	178
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (13.5)	60.8 (13.4)	59.5 (13.5)
Sex: Female, Male (Count of Participants)
Female	36 38.7%	41 48.2%	77 43.3%
Male	57 61.3%	44 51.8%	101 56.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 2.2%	2 2.4%	4 2.2%
Not Hispanic or Latino	91 97.8%	83 97.6%	174 97.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	33 35.5%	33 38.8%	66 37.1%
White	59 63.4%	51 60%	110 61.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 1.1%	1 1.2%	2 1.1%
Region of Enrollment (participants) [Number]
United States	93 100%	85 100%	178 100%
Etiology of ESRD (Count of Participants)
Diabetes	37 39.8%	34 40%	71 39.9%
Hypertension	19 20.4%	30 35.3%	49 27.5%
Glomerular disease	14 15.1%	6 7.1%	20 11.2%
Polycystic disease	5 5.4%	1 1.2%	6 3.4%
Neoplasms/tumors	9 9.7%	4 4.7%	13 7.3%
Other	9 9.7%	10 11.8%	19 10.7%

Outcome Measures

1. Primary Outcome

Title	Time Specific Interdialytic Weight Gain (Baseline)
Description	Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	88	80
Mean (Standard Deviation) [kg/day]	1.2 (0.6)	1.2 (0.5)

2. Primary Outcome

Title	Time Specific Interdialytic Weight Gain (8 Weeks)
Description	Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	81	80
Mean (Standard Deviation) [kg/day]	1.1 (0.6)	1.2 (0.5)

3. Primary Outcome

Title	Time Specific Interdialytic Weight Gain (12 Weeks)
Description	Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	80	79
Mean (Standard Deviation) [kg/day]	1.2 (0.5)	1.2 (0.5)

4. Primary Outcome

Title	Time Specific Interdialytic Weight Gain (16 Weeks)
Description	Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	78	79
Mean (Standard Deviation) [kg/day]	1.1 (0.6)	1.2 (0.5)

5. Primary Outcome

Title	Time Specific Dietary Sodium Intake (Baseline)
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Some participants have missing sodium data due to missed dietary recalls.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	92	85
Mean (Standard Deviation) [mg/day]	2555 (2090)	2298 (957)

6. Primary Outcome

Title	Time Specific Dietary Sodium Intake (8 Weeks)
Description	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.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Some participants have missing sodium data due to missed dietary recalls.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	82	80
Mean (Standard Deviation) [mg/day]	2316 (931)	2573 (1139)

7. Primary Outcome

Title	Time Specific Dietary Sodium Intake (16 Weeks)
Description	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.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Some participants have missing sodium data due to missed dietary recalls.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	78	78
Mean (Standard Deviation) [mg/day]	2371 (1483)	2447 (1067)

8. Primary Outcome

Title	Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)
Description	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.
Time Frame	Baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

Some participants have missing sodium data due to missed dietary recalls.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	82	79
Mean (Standard Deviation) [mg/day]	-71 (1027)	237 (991)

9. Primary Outcome

Title	Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)
Description	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.
Time Frame	Baseline to 16 weeks

Outcome Measure Data

Analysis Population Description

Some participants have missing sodium data due to missed dietary recalls.

Arm/Group Title	Intervention	Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.	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. Attention Control: 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.
Measure Participants	78	77
Mean (Standard Deviation) [mg/day]	59 (1483)	131 (993)

Adverse Events

Time Frame	Adverse event data were collected for the duration of the study period (16 weeks).
Arm/Group Title	Intervention		Attention Control
Arm/Group Description	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. Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: 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 targetted counseling and engaged the participant in problem solving around dietary issues.		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. Attention Control: 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.
All Cause Mortality
	Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/93 (1.1%)		2/86 (2.3%)
Serious Adverse Events
	Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/93 (0%)		0/86 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/93 (0%)		0/86 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.