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

Not Applicable

Completed

• Conditions: Kidney Failure; Quality of Life; Hemodialysis; Mindfulness; Fluid Restriction; Interdialytic Weight Gain

• Registration Number: NCT04016311
• Lead Sponsor: University of Texas at Austin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-11
• Primary Completion: 2020-05-07
• Study Completion: 2020-05-07
• Results First Submitted: 2021-05-04
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Results First Posted: 2021-09-29
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Receiving hemodialysis
• Able to speak English

Exclusion Criteria

• Missed more than one dialysis treatment in the past month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Interdialytic Weight Gain (IWG)	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	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 Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas at Austin; 🇺🇸 Austin, Texas, United States