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

University of Pittsburgh22 enrolled

Overview

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

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

End-Stage Renal Disease

Interventions

Standard hemodialysis dietary instructionBEHAVIORAL

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

Behavioral counseling plus PDA-based self-monitoring of dietBEHAVIORAL

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

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: baseline and 4 months

average daily interdialytic weight gain (IDWG)

Time frame: IDWG gathered with each dialysis treatment

average pulse pressure from pre-dialysis blood pressures

Time frame: with each dialysis treatment

Secondary Outcomes

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

serum potassium and phosphorus levels

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

nutritional status as determined from serum albumin

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