Impact of a Personal Digital Assistant (PDA) - Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients (BalanceWise-HD)

This study has been completed.
Sponsor:
Collaborator:
Paul Teschan Research Fund
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00447408
First received: March 12, 2007
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

With this study the investigators will test, in a randomised clinical trial (RCT), the efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a 4-month PDA-based dietary counseling intervention or to a 4-month attention control. Potential participants will be stratified by whether or not they have diabetes. Data on primary and secondary outcomes will be obtained at baseline and four months. Primary dependent variables are:

  1. adherence to dietary sodium targets as assessed from 3-day food recalls,
  2. average monthly interdialytic weight gain, and
  3. average pulse pressure. Secondary dependent variables are:
  4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. Laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the Nutrient Data System.

Condition Intervention
End-Stage Renal Disease
Behavioral: Standard hemodialysis dietary instruction
Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • adherence to dietary sodium targets as assessed from 3-day food recalls [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
  • average daily interdialytic weight gain (IDWG) [ Time Frame: IDWG gathered with each dialysis treatment ] [ Designated as safety issue: No ]
  • average pulse pressure from pre-dialysis blood pressures [ Time Frame: with each dialysis treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls [ Time Frame: collected at baseline and 4 months ] [ Designated as safety issue: No ]
  • serum potassium and phosphorus levels [ Time Frame: baseline, and 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]
  • nutritional status as determined from serum albumin [ Time Frame: baseline, 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Education in the hemodialysis diet.
Behavioral: Standard hemodialysis dietary instruction
Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
Experimental: B
Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.
Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet
Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments. In addition they receive behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Those individuals who are 21 years of age or older
  • Literate
  • Community-dwelling adults
  • Receiving maintenance HD for at least 3 months

Exclusion Criteria:

  • Individuals 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 6 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.
  • Those individuals with a score ≤ 26 on the Mini Mental Status Exam.
  • Also excluded will be individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00447408

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Paul Teschan Research Fund
Investigators
Principal Investigator: Mary A Sevick, ScD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Mary Ann Sevick, ScD, School of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00447408     History of Changes
Other Study ID Numbers: 0605006
Study First Received: March 12, 2007
Last Updated: June 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
hemodialysis
dietary adherence
sodium

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Weight Gain
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014