Intervention to Reduce Dietary Sodium in Hemodialysis

NCT01125202 | Completed Results DMC

• 2 other identifiers: PRO08040361R01NR010135
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis

Keywords

Intervention studies; Computers, handheld; Randomized controlled trial; Sodium, dietary

Outcome Measures

Primary Outcomes (9)

• Time Specific Interdialytic Weight Gain (Baseline)

  Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.

  Baseline

• Time Specific Interdialytic Weight Gain (8 Weeks)

  Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.

  8 weeks

• Time Specific Interdialytic Weight Gain (12 Weeks)

  Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.

  12 weeks

• Time Specific Interdialytic Weight Gain (16 Weeks)

  Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.

  16 weeks

• Time Specific Dietary Sodium Intake (Baseline)

  Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.

  Baseline

• Time Specific Dietary Sodium Intake (8 Weeks)

  Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.

  8 weeks

• Time Specific Dietary Sodium Intake (16 Weeks)

  Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.

  16 weeks

• Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)

  Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. The difference between measurement time points was determined.

  Baseline to 8 weeks

• Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)

  Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.

  Baseline to 16 weeks

Study Arms (2)

SCT-based behavioral intervention

EXPERIMENTAL

Intervention participants continue to receive routine dialysis care, as well as a 16 week dietary counseling intervention based on Social Cognitive Theory. Dietary counseling is paired with Personal Digital Assistant-based dietary self-monitoring.

Behavioral: SCT-based behavioral intervention

Attention control

ACTIVE COMPARATOR

Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.

Behavioral: Attention Control

Interventions

SCT-based behavioral intervention BEHAVIORAL

Intervention group continues to receive routine dialysis care. The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targeted counseling and engaged the participant in problem solving around dietary issues.

SCT-based behavioral intervention

Attention Control BEHAVIORAL

Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.

Attention control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Iowa: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

  PMID: 36472416 DERIVED

• 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.

  PMID: 34164803 DERIVED

• 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.

  PMID: 26868602 DERIVED

Results Point of Contact

• Title: Mary Ann Sevick, ScD
• Organization: New York University School of Medicine

mary.sevick@nyumc.org

6465012621

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 18, 2010
• Study Start: September 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: August 15, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-08

Locations

US (1)