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

Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients

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 Overview

• Status: Completed
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Behavioral: Standard hemodialysis dietary instruction; Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Education in the hemodialysis diet.	Behavioral: Standard hemodialysis dietary instruction; Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
Experimental: B; Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
adherence to dietary sodium targets as assessed from 3-day food recalls	baseline and 4 months
average daily interdialytic weight gain (IDWG)	IDWG gathered with each dialysis treatment
average pulse pressure from pre-dialysis blood pressures	with each dialysis treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls	collected at baseline and 4 months
serum potassium and phosphorus levels	baseline, and 1, 2, 3, and 4 months
nutritional status as determined from serum albumin	baseline, 1, 2, 3, and 4 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Paul Teschan Research Fund
• Investigators: Principal Investigator: Mary A Sevick, ScD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: March 12, 2007
• First Submitted That Met QC Criteria: March 12, 2007
• First Posted (Estimate): March 14, 2007

Study Record Updates

• Last Update Posted (Estimate): June 28, 2010
• Last Update Submitted That Met QC Criteria: June 24, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: hemodialysis; dietary adherence; sodium
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Body Weight; Body Weight Changes; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Weight Gain
• Other Study ID Numbers: 0605006