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

Sponsor
Academy of Nutrition and Dietetics (Other)
Overall Status
Completed
CT.gov ID
NCT02130089
Collaborator
(none)
50
1
1
19
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intensive Tailored Education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: All patients

Intensive tailored education

Behavioral: Intensive Tailored Education

Outcome Measures

Primary Outcome Measures

  1. Average Percent Interdialytic Weight Gain [monthly for 7 months]

Secondary Outcome Measures

  1. Thirst Intensity [monthly for 7 months]

    will be measured by a 100 mm Visual Analog Scale. Patients are asked to mark the point on the VAS which represents their work thirst since the last dialysis. Zero is considered no thirst and 100 is extremely thirsty. This tool has been shown to correlate to the Thirst Distress tool developed by Welsh in 2002.

  2. Sodium and Fluid Knowledge [Monthly for 4 months]

    Will be assessed using the sodium questions of the tool created by Kim (Korean J Nutr 2001), as modified by Park (J Ren Nutr 2008).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Auckland Board of Health Auckland New Zealand

Sponsors and Collaborators

  • Academy of Nutrition and Dietetics

Investigators

  • Principal Investigator: Sandra McLellan, Auckland Board of Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alison Steiber, Chief Science Officer, Academy of Nutrition and Dietetics
ClinicalTrials.gov Identifier:
NCT02130089
Other Study ID Numbers:
  • 13-186
First Posted:
May 5, 2014
Last Update Posted:
Jan 27, 2016
Last Verified:
Jan 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2016