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

NCT00447408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2010-06-28

No results posted yet for this study

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.

Conditions

  • End-Stage Renal Disease

Interventions

BEHAVIORAL

Standard hemodialysis dietary instruction

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

BEHAVIORAL

Behavioral counseling plus PDA-based self-monitoring of diet

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.

Sponsors & Collaborators

  • Paul Teschan Research Fund

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Mary A Sevick, ScD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447408 on ClinicalTrials.gov