Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?

NCT02130089 | Completed

• 1 other identifier: 13-186
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.

Conditions

End Stage Renal Disease Requiring Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Average Percent Interdialytic Weight Gain

  monthly for 7 months

Secondary Outcomes (2)

• Thirst Intensity

  monthly for 7 months

• Sodium and Fluid Knowledge

  Monthly for 4 months

Study Arms (1)

All patients

OTHER

Intensive tailored education

Behavioral: Intensive Tailored Education

Interventions

Intensive Tailored Education BEHAVIORAL

All patients

Eligibility Criteria

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

You may qualify if:

• Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
• Able to sign the locally approved informed consent
• Willing to receive dietitian education on sodium and fluid control during normal dialysis time
• Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years

You may not qualify if:

• On hospice or international equivalent
• Receiving corticosteroid treatment
• Less than 18 years old
• On interdialytic parenteral nutrition
• Transfer to another facility expected within 3 months
• Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool

Sponsors & Collaborators

• Academy of Nutrition and Dietetics: lead

Study Sites (1)

Auckland Board of Health

Auckland, New Zealand

Location

Study Officials

• Sandra McLellan

  Auckland Board of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 5, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

NZ (1)