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Completed

NCT Number: NCT00447408

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard hemodialysis dietary instruction

Behavioral

Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.

Behavioral counseling plus PDA-based self-monitoring of diet

Behavioral

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.

Primary outcomes

  1. adherence to dietary sodium targets as assessed from 3-day food recalls

    Time frame: baseline and 4 months

  2. average daily interdialytic weight gain (IDWG)

    Time frame: IDWG gathered with each dialysis treatment

  3. average pulse pressure from pre-dialysis blood pressures

    Time frame: with each dialysis treatment

Secondary outcomes

  1. 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

  2. serum potassium and phosphorus levels

    Time frame: baseline, and 1, 2, 3, and 4 months

  3. nutritional status as determined from serum albumin

    Time frame: baseline, 1, 2, 3, and 4 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Paul Teschan Research Fund

Registry information

Official study title

Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients

Acronym: BalanceWise-HD

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 14, 2007
Registry last updated
Jun 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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