CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 179 enrolled
Drug / intervention
SCT-based behavioral intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01125202
NCT01125202N/ACompleted

Intervention to Reduce Dietary Sodium in Hemodialysis

University of Pittsburgh·interventional·Posted May 18, 2010·Updated Aug 15, 2017

In Brief

A clinical study evaluating SCT-based behavioral intervention and Attention Control for Renal Dialysis. Completed, enrolled 179 participants across 1 site.

Detailed Summary

The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Dialysis
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2010
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.1 years ago

Interventions

SCT-based behavioral interventionbehavioral

Intervention group continues to receive routine dialysis care. 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 targeted counseling and engaged the participant in problem solving around dietary issues.

Attention Controlbehavioral

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.