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

End-Stage Renal Disease Clinical Trial

— BalanceWise-HD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447408
• Other study ID #: 0605006
• Status: Completed
• Phase: N/A
• First received: March 12, 2007
• Last updated: June 24, 2010
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: June 2010
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Paul Teschan Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to dietary sodium targets as assessed from 3-day food recalls		baseline and 4 months	No
Primary	average daily interdialytic weight gain (IDWG)		IDWG gathered with each dialysis treatment	No
Primary	average pulse pressure from pre-dialysis blood pressures		with each dialysis treatment	No
Secondary	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	No
Secondary	serum potassium and phosphorus levels		baseline, and 1, 2, 3, and 4 months	No
Secondary	nutritional status as determined from serum albumin		baseline, 1, 2, 3, and 4 months	No