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Intervention to Reduce Dietary Sodium in Hemodialysis (BalanceWise-HD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01125202
First Posted: May 18, 2010
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Iowa
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Mary Ann Sevick, University of Pittsburgh
Results First Submitted: June 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Renal Dialysis
Interventions: Behavioral: SCT-based behavioral intervention
Behavioral: Attention Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 17 dialysis centers, from the 3 corporate chains, between September 2009 and September 2012. Of the 848 HD patients available, 257 were eligible, 191 consented, 185 provided baseline data, 179 were randomized, and 160 (89.4%) completed the final 16-week measurement assessment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intervention

Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.

Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues.

Attention Control

Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.

Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.


Participant Flow:   Overall Study
    Intervention   Attention Control
STARTED   93   86 
COMPLETED   81   79 
NOT COMPLETED   12   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One attention control participant was hospitalized after enrollment and did not have a baseline data collection form.

Reporting Groups
  Description
Intervention

Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.

Social Cognitive Theory based dietary counseling paired with personal digital assistant based self-monitoring: The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targetted counseling and engaged the participant in problem solving around dietary issues.

Attention Control

Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.

Attention Control: Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.

Total Total of all reporting groups

Baseline Measures
   Intervention   Attention Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   85   178 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.1  (13.5)   60.8  (13.4)   59.5  (13.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      36  38.7%      41  48.2%      77  43.3% 
Male      57  61.3%      44  51.8%      101  56.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   2.2%      2   2.4%      4   2.2% 
Not Hispanic or Latino      91  97.8%      83  97.6%      174  97.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      33  35.5%      33  38.8%      66  37.1% 
White      59  63.4%      51  60.0%      110  61.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.1%      1   1.2%      2   1.1% 
Region of Enrollment 
[Units: Participants]
     
United States   93   85   178 
Etiology of ESRD [1] 
[Units: Participants]
Count of Participants
     
Diabetes      37  39.8%      34  40.0%      71  39.9% 
Hypertension      19  20.4%      30  35.3%      49  27.5% 
Glomerular disease      14  15.1%      6   7.1%      20  11.2% 
Polycystic disease      5   5.4%      1   1.2%      6   3.4% 
Neoplasms/tumors      9   9.7%      4   4.7%      13   7.3% 
Other      9   9.7%      10  11.8%      19  10.7% 
[1] Etiology of ESRD


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time Specific Interdialytic Weight Gain (Baseline)   [ Time Frame: Baseline ]

2.  Primary:   Time Specific Interdialytic Weight Gain (8 Weeks)   [ Time Frame: 8 weeks ]

3.  Primary:   Time Specific Interdialytic Weight Gain (12 Weeks)   [ Time Frame: 12 weeks ]

4.  Primary:   Time Specific Interdialytic Weight Gain (16 Weeks)   [ Time Frame: 16 weeks ]

5.  Primary:   Time Specific Dietary Sodium Intake (Baseline)   [ Time Frame: Baseline ]

6.  Primary:   Time Specific Dietary Sodium Intake (8 Weeks)   [ Time Frame: 8 weeks ]

7.  Primary:   Time Specific Dietary Sodium Intake (16 Weeks)   [ Time Frame: 16 weeks ]

8.  Primary:   Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)   [ Time Frame: Baseline to 8 weeks ]

9.  Primary:   Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)   [ Time Frame: Baseline to 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary Ann Sevick, ScD
Organization: New York University School of Medicine
phone: 6465012621 ext 646
e-mail: mary.sevick@nyumc.org



Responsible Party: Mary Ann Sevick, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01125202     History of Changes
Other Study ID Numbers: PRO08040361
R01NR010135 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2010
First Posted: May 18, 2010
Results First Submitted: June 14, 2017
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017