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

University of Pittsburgh

Status

Completed

Conditions

End-Stage Renal Disease

Treatments

Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet

Behavioral: Standard hemodialysis dietary instruction

Study type

Interventional

Funder types

Other

Identifiers

NCT00447408

0605006

Details and patient eligibility

About

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:

adherence to dietary sodium targets as assessed from 3-day food recalls,
average monthly interdialytic weight gain, and
average pulse pressure. Secondary dependent variables are:
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.

Enrollment

22 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.