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

NCT ID: NCT04016311

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2020-05-07

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindful Drinking/Eating Group

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.

Group Type: EXPERIMENTAL

Mindful Drinking/Eating Intervention

Intervention Type: BEHAVIORAL

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.

Wait list control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Receiving hemodialysis
• Able to speak English

Exclusion Criteria

• Missed more than one dialysis treatment in the past month

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

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Gayle Timmerman,

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-01-0074

Identifier Type: -

Identifier Source: org_study_id