Official Title: “Impact of a 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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Behavioral: Education control - standard hemodialysis dietary instruction
  • Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
• Behavioral: Intervention - behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Education in the hemodialysis diet.
• Experimental: B
  • Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

Primary Measures

• adherence to dietary sodium targets as assessed from 3-day food recalls
  • Time Frame: baseline and 4 months
    Safety Issue?: No
• average daily interdialytic weight gain (IDWG)
  • Time Frame: IDWG gathered with each dialysis treatment
    Safety Issue?: No
• average pulse pressure from pre-dialysis blood pressures
  • Time Frame: with each dialysis treatment
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• serum potassium and phosphorus levels
  • Time Frame: baseline, and 1, 2, 3, and 4 months
    Safety Issue?: No
• nutritional status as determined from serum albumin
  • Time Frame: baseline, 1, 2, 3, and 4 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Mary A Sevick, ScD Principal Investigator University of Pittsburgh  

Overall Contact: Beth M Hall, BA (412)586-9791 hallbm@upmc.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00447408

Study ID Number: 0605006

ClinicalTrials.gov Identifier: NCT00447408

Health Authority: United States: Institutional Review Board