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

Not Applicable

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Behavioral: Standard hemodialysis dietary instruction; Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet

• Registration Number: NCT00447408
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-14
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Those individuals who are 21 years of age or older
• Literate
• Community-dwelling adults
• Receiving maintenance HD for at least 3 months

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Standard hemodialysis dietary instruction	Education in the hemodialysis diet.
B	Behavioral counseling plus PDA-based self-monitoring of diet	Education in the hemodialysis diet. Behavioral counseling paired with PDA-based self-monitoring of dietary sodium intake.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States