Intervention to Reduce Dietary Sodium in Hemodialysis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125202

Acronym

BalanceWise-HD

Enrollment

179

Registered

2010-05-18

Start date

2009-09-30

Completion date

2012-09-30

Last updated

2017-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

Intervention studies, Computers, handheld, Randomized controlled trial, Sodium, dietary

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.

Interventions

BEHAVIORALSCT-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.

BEHAVIORALAttention 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

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.

Participants by arm

Arm	Count
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. 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.	93
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. 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.	85
Total	178

Baseline characteristics

Characteristic	Attention Control	Total	Intervention
Age, Continuous	60.8 years STANDARD_DEVIATION 13.4	59.5 years STANDARD_DEVIATION 13.5	59.1 years STANDARD_DEVIATION 13.5
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	4 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	83 Participants	174 Participants	91 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Etiology of ESRD Diabetes	34 Participants	71 Participants	37 Participants
Etiology of ESRD Glomerular disease	6 Participants	20 Participants	14 Participants
Etiology of ESRD Hypertension	30 Participants	49 Participants	19 Participants
Etiology of ESRD Neoplasms/tumors	4 Participants	13 Participants	9 Participants
Etiology of ESRD Other	10 Participants	19 Participants	9 Participants
Etiology of ESRD Polycystic disease	1 Participants	6 Participants	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	33 Participants	66 Participants	33 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) White	51 Participants	110 Participants	59 Participants
Region of Enrollment United States	85 participants	178 participants	93 participants
Sex: Female, Male Female	41 Participants	77 Participants	36 Participants
Sex: Female, Male Male	44 Participants	101 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 93	2 / 86
other Total, other adverse events	0 / 93	0 / 86
serious Total, serious adverse events	0 / 93	0 / 86

Outcome results

Primary

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.

Time frame: Baseline to 16 weeks