Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447408
Status:
COMPLETED
Last Update Posted:
2010-06-28
First Post:
2007-03-12
Brief Title:
Impact of a Personal Digital Assistant PDA - Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BalanceWise-HD
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None