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

Study Overview
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Brief Summary
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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.

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

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Behavioral: Standard hemodialysis dietary instruction
* Behavioral: Behavioral counseling plus PDA-based self-monitoring of diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Education in the hemodialysis diet. | Behavioral: Standard hemodialysis dietary instruction<br>* Participants receive standard hemodialysis dietary instruction via a PowerPoint presentation delivered during routinely scheduled dialysis treatments.<br>|
| Experimental: B<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, dietary adherence, sodium