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

This study has been completed.
Sponsor:
Collaborators:
University of Iowa
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Mary Ann Sevick, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01125202
First received: May 14, 2010
Last updated: August 14, 2017
Last verified: August 2017
May 14, 2010
August 14, 2017
September 2009
September 2012   (Final data collection date for primary outcome measure)
  • Time Specific Interdialytic Weight Gain (Baseline) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
  • Change in interdialytic weight gain over time [ Time Frame: 16 weeks ]
    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 ]
    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 ]
    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 ]
    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.
Complete list of historical versions of study NCT01125202 on ClinicalTrials.gov Archive Site
Not Provided
  • Blood pressure [ Time Frame: Each dialysis treatment over a 4-month time period ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Qualitative data interview are obtained eliciting participants' experiences with the hemodialysis diet and their experience with the intervention.
Not Provided
Not Provided
 
Intervention to Reduce Dietary Sodium in Hemodialysis
Intervention to Reduce Dietary Sodium in Hemodialysis
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Dialysis
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: SCT-based behavioral intervention
  • 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.
    Intervention: Behavioral: Attention Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
September 2012
September 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01125202
PRO08040361
R01NR010135 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Mary Ann Sevick, University of Pittsburgh
University of Pittsburgh
  • University of Iowa
  • National Institute of Nursing Research (NINR)
Not Provided
University of Pittsburgh
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP