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Clinical Trials/NCT04016311
NCT04016311
Completed
Not Applicable

A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions

University of Texas at Austin1 site in 1 country38 target enrollmentJune 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Failure
Sponsor
University of Texas at Austin
Enrollment
38
Locations
1
Primary Endpoint
Interdialytic Weight Gain (IWG)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this pilot study is to find out whether mindful drinking/eating activities can improve quality of life and help make it easier for people on dialysis to follow their fluid restrictions. The pilot study is a randomized controlled trial with an intervention group and a wait list control group, randomized by cohort days. The intervention occurs during dialysis sessions once a week for 4 weeks. During each intervention session, participants are guided through a mindful eating exercise focused on foods recommended for controlling thirst (e.g., hard candy, frozen grapes) and a mindful drinking exercise. Participants are asked to practice mindful drinking/eating at least once daily at home.

Registry
clinicaltrials.gov
Start Date
June 25, 2019
End Date
May 7, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gayle Timmerman,

Associate Professor

University of Texas at Austin

Eligibility Criteria

Inclusion Criteria

  • Receiving hemodialysis
  • Able to speak English

Exclusion Criteria

  • Missed more than one dialysis treatment in the past month

Outcomes

Primary Outcomes

Interdialytic Weight Gain (IWG)

Time Frame: 4 weeks

Average of 3 Interdialytic Weight gain measures taken the week after last intervention section (4 week time frame). Interdialytic weight gain is calculated as the patients' weight at the beginning of each hemodialysis session (pre-weight) minus the weight after the previous hemodialysis session (post-weight). Measured in kilograms. Lower numbers are better. Proxy measure for adhering to fluid restriction.

Total Score for Kidney-Disease Quality of Life Short Form v1.3

Time Frame: 4 weeks

Total Score for Kidney-Disease Quality of Life Short Form v1.3 Higher scores indicate greater quality of life. Score range from 0 to 100

Secondary Outcomes

  • Mindful Eating(4 weeks)

Study Sites (1)

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