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

Completed · Not applicable

Conditions studied: End-Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT00447408

Run by

University of Pittsburgh

People needed

22

Starts

2007-01-01

Expected to finish

2009-01-01

Last updated by the study team

2010-06-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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