Clinical trial NCT01125202: Intervention to Reduce Dietary Sodium in Hemodialysis
Official title: Intervention to Reduce Dietary Sodium in Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Keywords: Intervention studies
Computers, handheld
Randomized controlled trial
Sodium, dietary
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: National Institute of Nursing Research (NINR)
First posted: 2010-05-18
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cardiovascular disease is the single most common cause of death in hemodialysis (HD) patients. Most HD patients have left ventricular hypertrophy(LVH), a significant predictor of death in this population. LVH is related to extracellular volume expansion and hypertension, both of which are amenable to dietary sodium restriction. However, dietary change is widely known to be difficult to achieve and sustain. Controlling dietary sodium is particularly difficult for HD because many foods are naturally high in sodium, and most prepared/prepackaged foods have significant amounts of sodium added to enhance taste and shelf-life. Research on behavioral methods that are effective in reducing dietary sodium intake in HD is very limited. The purpose of this study is to test, in a randomized clinical trial of 200 HD patients, a behavioral intervention, paired with personal digital assistant (PDA)-based dietary self-monitoring, to enhance adherence to dietary sodium restrictions. Specifically the investigators will: (a) Assess the impact of the intervention on average daily interdialytic weight gains (IDWG-A). (b) Examine the impact of the intervention on self-reported dietary sodium intake. The study hypotheses are that compared to the control group, the intervention group will: (1) demonstrate a statistically significant decline in IDWG-A over the 4-month intervention period, and (2) experience a greater decline in dietary sodium intake. Secondarily, the investigators will explore the impact of the intervention on: (a) pre-dialysis pulse pressure and mean arterial blood pressure, (b) hemodialysis dietary self-efficacy, and (c) intradialytic and postdialytic symptoms and general health-related quality of life. In addition, the investigators will characterize the barriers/facilitators to adherence to the HD dietary regimen and patient experience of the intervention through the use of qualitative methods. The intervention is based on Social Cognitive Theory (SCT). Self-monitoring within the context of the intervention is operationalized as PDA-based dietary recording using BalanceLog software. Participants randomized to the attention control will receive computerized dietary education. Attention control participants will be offered an abbreviated version of the intervention after the 4-month study period concludes. Differences in IDWG-A, pulse pressure, and mean arterial pressure will be examined using a random intercept linear regression modeling. Self-reported dietary sodium, self-efficacy, symptoms, and quality of life will be assessed at baseline, 6 weeks, and 4 month and differences will be examined using repeated measures modeling using GEE. Qualitative analysis of narrative data will be performed.

Eligibility criteria: Inclusion Criteria:

* Individuals with end stage renal disease (ESRD) who are 18 years of age or older,
* Individuals who are literate,
* Community-dwelling adults who have been receiving maintenance dialysis for at least 3 months.

Exclusion Criteria:

* Individuals who cannot read or write,
* Individuals who do not speak English,
* Individuals who plan to move out of the area or change dialysis centers within the next 6 months,
* Individuals who have a life expectancy of less than 12 months,
* Individuals who are scheduled for a living donor transplant,
* Individuals who cannot see the PDA screen or use the stylus to make food selections from the PDA screen, or
* Individuals who live in an institutional setting in which they would have limited control over their dietary intake.

Primary outcomes:
measure: Time Specific Interdialytic Weight Gain (Baseline)
timeFrame: Baseline
measure: Time Specific Interdialytic Weight Gain (8 Weeks)
timeFrame: 8 weeks
measure: Time Specific Interdialytic Weight Gain (12 Weeks)
timeFrame: 12 weeks
measure: Time Specific Interdialytic Weight Gain (16 Weeks)
timeFrame: 16 weeks
measure: Time Specific Dietary Sodium Intake (Baseline)
timeFrame: Baseline
measure: Time Specific Dietary Sodium Intake (8 Weeks)
timeFrame: 8 weeks
measure: Time Specific Dietary Sodium Intake (16 Weeks)
timeFrame: 16 weeks
measure: Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)
timeFrame: Baseline to 8 weeks
measure: Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)
timeFrame: Baseline to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
Study officials:
References:
citation: McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
citation: Sevick MA, Piraino BM, St-Jules DE, Hough LJ, Hanlon JT, Marcum ZA, Zickmund SL, Snetselaar LG, Steenkiste AR, Stone RA. No Difference in Average Interdialytic Weight Gain Observed in a Randomized Trial With a Technology-Supported Behavioral Intervention to Reduce Dietary Sodium Intake in Adults Undergoing Maintenance Hemodialysis in the United States: Primary Outcomes of the BalanceWise Study. J Ren Nutr. 2016 May;26(3):149-58. doi: 10.1053/j.jrn.2015.11.006. Epub 2016 Feb 9.