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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016311
• Other study ID #: 2019-01-0074
• Status: Completed
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: May 7, 2020

Study information

• Verified date: September 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 7, 2020
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Receiving hemodialysis
• Able to speak English

Exclusion Criteria:

• Missed more than one dialysis treatment in the past month

Related Conditions & MeSH terms

• Fluid Restriction
• Hemodialysis
• Interdialytic Weight Gain
• Kidney Failure
• Mindfulness
• Quality of Life
• Renal Insufficiency
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Primary	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.	4 weeks
Secondary	Mindful Eating	Total score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating.	4 weeks