Original ResearchNo 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
Introduction
Mortality among hemodialysis (HD) patients remains high in the United States, with cardiovascular causes accounting for more than one-third of mortality in incident and prevalent end-stage renal disease (ESRD) patients.1 One factor contributing to poor cardiovascular outcomes is chronic volume overload,2, 3 which is a function of excess fluid intake in relation to residual renal function and fluid removal with dialysis treatments. Interdialytic weight gain (IDWG) is commonly used as an indirect measure of fluid intake in HD patients. Differences in IDWG as small as 0.51 kg (less than 2¼ cups of fluid) have been shown to be independently associated with uncontrolled hypertension in HD patients,4 which contributes to left ventricular hypertrophy.5 According to the US Renal Data System, all-cause mortality is highest on the first treatment day of the week after the 2-day weekend hiatus from HD (when fluid volume for the week is likely at its highest).6 Because rapid fluid removal is associated with cardiovascular morbidity and mortality,7 the focus must be on longer HD treatments (often not well received by patients) and on decreasing IDWGs.
Dietary sodium intake is a modifiable behavior that is associated with higher IDWG8 and all-cause mortality in HD patients. Although sodium restriction is recommended routinely for HD patients,9, 10 the pervasive use of sodium chloride (as salt) by food manufacturers and food service operations and increased reliance on these foods makes sodium restriction difficult.11, 12, 13, 14 Despite long-standing recommendations to limit sodium intakes in the United States, average dietary sodium intake in the general population has remained stable in amounts approximately 1.5 times the tolerable upper intake level.15, 16 Adopting a lower sodium diet may be even more difficult for HD patients, as they may experience greater barriers to dietary change than does the general population (e.g., ill health, a time-consuming treatment regimen, numerous other dietary restrictions). The purpose of the BalanceWise Study was to evaluate the efficacy of a technology-supported behavioral intervention for reducing IDWGs and dietary sodium intake in patients undergoing intermittent HD. Our hypotheses were that, compared with the attention control group, the intervention group would demonstrate a lower average daily interdialytic weight gain (IDWGA) and lower dietary sodium intake at 8 weeks and that these changes would be sustained at 16 weeks.
Section snippets
Design
The BalanceWise Study was a randomized clinical trial of maintenance HD patients recruited from 3 dialysis chains comprising 17 dialysis units in Western Pennsylvania (DaVita HealthCare Partners Inc., Dialysis Clinic Inc., and Fresenius Medical Care North America). Within dialysis units, participants were randomized to either an intervention of 16-week duration or an attention control. The intervention consisted of behavioral counseling paired with dietary self-monitoring using a handheld
Results
Participants were recruited during September 2009 through 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. The CONSORT diagram is shown in Figure 1. The primary reasons for study exclusion for those patients who signed the HIPAA release and participated in baseline screening were: unwillingness to record diet, difficulty reading a newspaper,
Discussion
In this report, we have presented the primary outcomes of the BalanceWise study. No differences were seen in IDWGAs, either between groups at each follow-up time or overtime in within either group. However, the differential change in reported dietary sodium intake at 8 weeks provides some encouragement that the technology-supported behavioral intervention may impact behavior, at least in the short term; this effect was not sustained at 16 weeks.
Despite recommendations to limit sodium intake,
Practical Application
The use of technology-based self-monitoring to support a behavioral intervention targeting dietary sodium restriction appears to be feasible and acceptable to HD patients. Although the intervention did not affect IDWGAs, it was somewhat efficacious in reducing dietary sodium intake at 8 weeks but not at 16 weeks. Additional research is needed to examine the extent to which such an intervention is efficacious for those who are initiating HD, demonstrating consistently excessive IDWGs, and/or
Acknowledgments
The authors thank the management and staff of the participating dialysis units from DaVita HealthCare Partners Inc., Dialysis Clinic Inc., and Fresenius Medical Care North America; research study dietitians Beth Hall, BA, RD, LDN, and Susan Stark, MS, RD, CSR, LDN, for conducting the interventions; Deborah Klinvex, BA, for conducting the dietary recall interviews; D. Scott Obrosky, MS, for developing the data tracking system, and Tienna Luster for data management.
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Support: The work of this article was supported by the following National Institutes of Health (NIH) grants: NINR/R01-NR010135, NINR/NIDDk/NHLBI/NIA-K24-NR012226, NIA/R01-AG02717, NIA/P30-AG024827 & NIA/K07-AG033174. The NIH played no role in study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication.
Financial Disclosure: The authors declare that they have no relevant financial interests.
Trial Registration. Clinicaltrials.gov identifier: NCT01125202.