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

Abstract

Objective: To evaluate the efficacy of behavioral counseling combined with technology-based self-monitoring for sodium restriction in hemodialysis (HD) patients. Design: Randomized clinical trial. Subjects: English literate adults undergoing outpatient, in-center intermittent HD for at least 3 months. Interventions: Over a 16-week period, both the intervention and the attention control groups were shown 6 educational modules on the HD diet. The intervention group also received social cognitive theory-based behavioral counseling and monitored their diets daily using handheld computers. Main Outcome Measures: Average daily interdialytic weight gain (IDWGA) was calculated for every week of HD treatment over the observation period by subtracting the post-dialysis weight at the previous treatment time (t-1) from the pre-dialysis weight at the current treatment time (t), dividing by the number of days between treatments. Three 24-hour dietary recalls were obtained at baseline, 8 weeks, and 16 weeks and evaluated using the Nutrient Data System for Research. Results: A total of 179 participants were randomized, and 160 (89.4%) completed final measurements. IDWGA did not differ significantly by treatment group at any time point considered (P > .79 for each). A significant differential change in dietary sodium intake observed at 8 weeks (-372 mg/day; P = .05) was not sustained at 16 weeks (-191 mg/day; P = .32). Conclusion: The BalanceWise Study intervention appeared to be feasible and acceptable to HD patients although IDWGA was unchanged and the desired behavioral changes observed at 8 weeks were not sustained. Unmeasured factors may have contributed to the mixed findings, and further research is needed to identify the appropriate patients for such interventions.