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

August 14, 2017 updated by: Mary Ann Sevick, University of Pittsburgh
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
179

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
8 weeks
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.
12 weeks
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.
16 weeks
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.
Baseline
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.
8 weeks
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.
16 weeks
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.
Baseline to 8 weeks
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.
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO08040361
  • R01NR010135 (U.S. NIH Grant/Contract)

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