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Randomized Controlled Trial
. 2016 May;26(3):149-58.
doi: 10.1053/j.jrn.2015.11.006. Epub 2016 Feb 9.

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

Mary Ann Sevick  1 , Beth M Piraino  2 , David E St-Jules  3 , Linda J Hough  4 , Joseph T Hanlon  2 , Zachary A Marcum  2 , Susan L Zickmund  5 , Linda G Snetselaar  6 , Ann R Steenkiste  7 , Roslyn A Stone  8
Affiliations
Randomized Controlled Trial

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

Mary Ann Sevick et al. J Ren Nutr. 2016 May.

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.

Trial registration: ClinicalTrials.gov NCT01125202.

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Figures

Figure 1
Figure 1
CONSORT diagram for the BalanceWise Study (September 2009 – April 2013)
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