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

Sponsors and Collaborators:	University of Pittsburgh Paul Teschan Research Fund
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00447408

Purpose

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.

Condition	Intervention
End-Stage Renal Disease	Behavioral: Education control - standard hemodialysis dietary instruction Behavioral: Intervention - behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake

MedlinePlus related topics: Dialysis Dietary Sodium Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

adherence to dietary sodium targets as assessed from 3-day food recalls [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ]
average daily interdialytic weight gain (IDWG) [ Time Frame: IDWG gathered with each dialysis treatment ] [ Designated as safety issue: No ]
average pulse pressure from pre-dialysis blood pressures [ Time Frame: with each dialysis treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls [ Time Frame: collected at baseline and 4 months ] [ Designated as safety issue: No ]
serum potassium and phosphorus levels [ Time Frame: baseline, and 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]
nutritional status as determined from serum albumin [ Time Frame: baseline, 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Education in the hemodialysis diet.	Behavioral: Education control - standard hemodialysis dietary instruction Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.
B: Experimental Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.	Behavioral: Intervention - behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447408

Contacts

Contact: Beth M Hall, BA	(412)586-9791	hallbm@upmc.edu
Contact: Debbie Klinvex, BA	(412)586-9853	klinvexdt@upmc.edu

Locations

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

Sponsors and Collaborators

University of Pittsburgh

Paul Teschan Research Fund

Investigators

Principal Investigator:

Mary A Sevick, ScD

University of Pittsburgh

More Information

Responsible Party:	School of Medicine, University of Pittsburgh ( Mary Ann Sevick, ScD )
Study ID Numbers:	0605006
Study First Received:	March 12, 2007
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00447408
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

hemodialysis
dietary adherence
sodium

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Body Weight Changes
Kidney Failure, Chronic
Kidney Diseases
Weight Gain
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009