Dietary Adherence Enhancement in Peritoneal Dialysis: BalanceWise-PD (BalanceWise-PD)

May 14, 2010 updated by: University of Pittsburgh

Dietary Adherence Enhancement in Peritoneal Dialysis

This randomized study will pilot test an intervention, based on self-efficacy theory and involving personal digital assistant (PDA)-based dietary self-monitoring, to improve adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal dialysis, will be recruited to the study. Participants will be randomized to one of 2 groups. Group A will receive a 4-month active intervention of decreasing intensity over time delivered via mail, telephone, and during regularly scheduled dialysis clinic visits. Group B will receive a 4-month attention control experience in which they receive reinforcement of standard dietary education. With this study the investigators will:

  1. Explore the impact of the intervention on dietary sodium intake,
  2. Explore the intervention on blood pressure,
  3. Explore the impact of the intervention on morning post dialysis weight (i.e. weight after conclusion of continuous cycling peritoneal dialysis (CCPD) or after long dwell for continuous ambulatory peritoneal dialysis (CAPD) patients, AND
  4. Explore the feasibility and acceptability of the intervention

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • 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
        • Dialysis Clinics, Inc.

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The investigators will recruit those individuals:

  • who are 18 years of age or older,
  • who are literate, community-dwelling adults, and
  • who have been receiving maintenance PD for at least 3 months. Individuals on maintenance PD less than 3 months are excluded to allow for patients to adjust to the PD regimen, and for stabilization of nutritional status in the early weeks of dialysis (i.e. they may be considered for the study after 3 months of dialysis)

Exclusion Criteria:

Excluded from the study will be individuals:

  • who are deemed by dialysis center staff to have a problem with cognitive function and to be chronically noncompliant to the dialysis regimen (e.g. misses multiple appointments and dialysis treatments),
  • those who cannot read or write, those who do not speak English,
  • those who plan to move out of the area or change dialysis centers within the next 5 months,
  • those with a terminal illness and life expectancy of less than 12 months,
  • those who are scheduled for a living donor transplant,
  • individuals who cannot see the PDA screen or use the stylus to make selections from the PDA screen, or
  • individuals who are living in a nursing home or personal care facility, who 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Intervention
Behavioral: BalanceWise-PD
Dietary counseling based on Social Cognitive Theory, paired with PDA-based dietary self-monitoring
Other: B
Attention control, standard dietary education
Behavioral: Attention control
Standard peritoneal dialysis dietary education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dietary sodium intake as assessed from 3-day recalls.
Time Frame: baseline and 4 months
baseline and 4 months
Dietary sodium effluent and urine concentration.
Time Frame: baseline and 4 months
baseline and 4 months
Morning blood pressure.
Time Frame: baseline and 4 months
baseline and 4 months
Morning post dialysis weight.
Time Frame: baseline and 4 months
baseline and 4 months
Feasibility and acceptability of PDA-based dietary monitoring.
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Dietary intake of protein, calories, and phosphorus.
Time Frame: baseline and 4 months
baseline and 4 months
Perceived dietary barriers.
Time Frame: baseline and 4 months
baseline and 4 months
Perceived dietary therapeutic efficacy.
Time Frame: baseline and 4 months
baseline and 4 months

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Mary A Sevick, ScD, University of Pittsburgh

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

November 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 17, 2010

Last Update Submitted That Met QC Criteria

May 14, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21DK067181 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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