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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Iowa
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01125202
First received: May 14, 2010
Last updated: May 17, 2010
Last verified: May 2010
  Purpose

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 Intervention
Renal Dialysis
Behavioral: Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring
Behavioral: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intervention to Reduce Dietary Sodium in Hemodialysis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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: 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.
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125202

Contacts
Contact: Linda J Hough, MPH (412)692-4864 houghlj@upmc.edu
Contact: Susan Stark, MS (412)864-3599 starsa2@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Linda J Hough, MPH    412-692-4864      
Contact: Mary A Sevick, ScD, RN    (412)586-9788    sevick@pitt.edu   
Principal Investigator: Mary A Sevick, ScD, RN         
Sub-Investigator: Beth Piraino, MD         
Sub-Investigator: Joseph Hanlon, PharmD         
Sub-Investigator: Roslyn A Stone, PhD         
Sponsors and Collaborators
University of Pittsburgh
University of Iowa
  More Information

No publications provided

Responsible Party: Mary Ann Sevick, ScD, RN, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier: NCT01125202     History of Changes
Other Study ID Numbers: PRO08040361, R01NR010135
Study First Received: May 14, 2010
Last Updated: May 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Intervention studies
Computers, handheld
Randomized controlled trial
Sodium, dietary

ClinicalTrials.gov processed this record on September 18, 2014