University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT00447408
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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Notify Me21 year and older
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
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.
Time frame: baseline and 4 months
Time frame: IDWG gathered with each dialysis treatment
Time frame: with each dialysis treatment
Time frame: collected at baseline and 4 months
Time frame: baseline, and 1, 2, 3, and 4 months
Time frame: baseline, 1, 2, 3, and 4 months
University of Pittsburgh
Other
Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
Acronym: BalanceWise-HD
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