Clinical trial NCT00447408: Impact of a Personal Digital Assistant (PDA) - Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
Official title: Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: hemodialysis
dietary adherence
sodium
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Paul Teschan Research Fund
First posted: 2007-03-14
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: adherence to dietary sodium targets as assessed from 3-day food recalls
timeFrame: baseline and 4 months
measure: average daily interdialytic weight gain (IDWG)
timeFrame: IDWG gathered with each dialysis treatment
measure: average pulse pressure from pre-dialysis blood pressures
timeFrame: with each dialysis treatment
Secondary outcomes:
measure: adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls
timeFrame: collected at baseline and 4 months
measure: serum potassium and phosphorus levels
timeFrame: baseline, and 1, 2, 3, and 4 months
measure: nutritional status as determined from serum albumin
timeFrame: baseline, 1, 2, 3, and 4 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary A Sevick, ScD
role: PRINCIPAL_INVESTIGATOR
References: