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

Primary Purpose

Kidney Failure, Quality of Life, Fluid Restriction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Drinking/Eating Intervention
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Receiving hemodialysis
  • Able to speak English

Exclusion Criteria:

  • Missed more than one dialysis treatment in the past month

Sites / Locations

  • The University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindful Drinking/Eating Group

Wait list control

Arm Description

Behavioral: Mindful Drinking/Eating Intervention Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.

Usual care. Offered intervention after post-test data collected.

Outcomes

Primary Outcome Measures

Total Score for Kidney-Disease Quality of Life Short Form v1.3
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
Interdialytic Weight Gain (IWG)
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.

Secondary Outcome Measures

Mindful Eating
Total score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating.

Full Information

First Posted
July 8, 2019
Last Updated
September 1, 2021
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04016311
Brief Title
A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions
Official Title
A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
May 7, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Quality of Life, Fluid Restriction, Interdialytic Weight Gain, Hemodialysis, Mindfulness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and wait list control groups with rolling admission.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindful Drinking/Eating Group
Arm Type
Experimental
Arm Description
Behavioral: Mindful Drinking/Eating Intervention Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
Usual care. Offered intervention after post-test data collected.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Drinking/Eating Intervention
Intervention Description
Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.
Primary Outcome Measure Information:
Title
Total Score for Kidney-Disease Quality of Life Short Form v1.3
Description
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
Time Frame
4 weeks
Title
Interdialytic Weight Gain (IWG)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mindful Eating
Description
Total score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receiving hemodialysis Able to speak English Exclusion Criteria: Missed more than one dialysis treatment in the past month
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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