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 extra cellular 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 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 (IDWGA). (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 IDWGA 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. 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 IDWGA, 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.

Public Health Relevance

The prevalence of end-stage renal disease (ESRD) is growing exponentially, largely due to the growing number of people with type 2 diabetes, obesity, and hypertension, and the aging of the population. The most common treatment approach for ESRD is hemodialysis (HD), a regimen which requires strict dietary sodium limitations to prevent fluid volume overload. With this study the investigators will evaluate the effectiveness of a behavioral intervention that involves technology- based dietary self-monitoring, for helping those on HD limit their dietary sodium intake.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
5R01NR010135-04
Application #
8101887
Study Section
Nursing Science: Adults and Older Adults Study Section (NSAA)
Program Officer
Mccloskey, Donna J
Project Start
2008-09-24
Project End
2012-12-31
Budget Start
2011-07-01
Budget End
2012-12-31
Support Year
4
Fiscal Year
2011
Total Cost
$449,393
Indirect Cost
Name
University of Pittsburgh
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
St-Jules, David E; Woolf, Kathleen; Pompeii, Mary Lou et al. (2016) Reexamining the Phosphorus-Protein Dilemma: Does Phosphorus Restriction Compromise Protein Status? J Ren Nutr 26:136-40
St-Jules, David E; Woolf, Kathleen; Pompeii, Mary Lou et al. (2016) Exploring Problems in Following the Hemodialysis Diet and Their Relation to Energy and Nutrient Intakes: The BalanceWise Study. J Ren Nutr 26:118-24
St-Jules, David E; Goldfarb, David S; Sevick, Mary Ann (2016) Nutrient Non-equivalence: Does Restricting High-Potassium Plant Foods Help to Prevent Hyperkalemia in Hemodialysis Patients? J Ren Nutr 26:282-7
Sevick, Mary Ann; Piraino, Beth M; St-Jules, David E et al. (2016) 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 t J Ren Nutr 26:149-58
Lo-Ciganic, Wei-Hsuan; Perera, Subashan; Gray, Shelly L et al. (2015) Statin use and decline in gait speed in community-dwelling older adults. J Am Geriatr Soc 63:124-9
Clark-Cutaia, Maya N; Ren, Dianxu; Hoffman, Leslie A et al. (2014) Adherence to hemodialysis dietary sodium recommendations: influence of patient characteristics, self-efficacy, and perceived barriers. J Ren Nutr 24:92-9
Clark-Cutaia, Maya N; Ren, Dianxu; Hoffman, Leslie A et al. (2013) Psychometric Validation of the Self-Efficacy for Restricting Dietary Salt in Hemodialysis Scale. Top Clin Nutr 28:384-391
Hanlon, Joseph T; Boudreau, Robert M; Perera, Subashan et al. (2013) Racial differences in antilipemic use and lipid control in high-risk older adults: post-Medicare Part D. Am Heart J 166:792-7
Lo-Ciganic, Wei-Hsuan; Boudreau, Robert M; Gray, Shelly L et al. (2013) Changes in cholesterol-lowering medications use over a decade in community-dwelling older adults. Ann Pharmacother 47:984-92
Marcum, Zachary A; Sevick, Mary Ann; Handler, Steven M (2013) Medication nonadherence: a diagnosable and treatable medical condition. JAMA 309:2105-6

Showing the most recent 10 out of 46 publications