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

NCT ID: NCT02130089

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All patients

Intensive tailored education

Group Type: OTHER

Intensive Tailored Education

Intervention Type: BEHAVIORAL

Interventions

Intensive Tailored Education

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academy of Nutrition and Dietetics

OTHER

Sponsor Role: lead

Responsible Party

Alison Steiber

Chief Science Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra McLellan

Role: PRINCIPAL_INVESTIGATOR

Auckland Board of Health

Locations

Auckland Board of Health

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

13-186

Identifier Type: -

Identifier Source: org_study_id