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

NCT04016311 | Completed Results

• 1 other identifier: 2019-01-0074
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Mindful Eating

  4 weeks

Study Arms (2)

Mindful Drinking/Eating Group

EXPERIMENTAL

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.

Behavioral: Mindful Drinking/Eating Intervention

Wait list control

NO INTERVENTION

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

Interventions

Mindful Drinking/Eating Intervention 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.

Mindful Drinking/Eating Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving hemodialysis
• Able to speak English

You may not qualify if:

• Missed more than one dialysis treatment in the past month

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Gayle M. Timmerman PhD, Professor
• Organization: The University of Texas at Austin, School of Nursing

gtimmerman@mail.utexas.edu

5124719087

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention and wait list control groups with rolling admission.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: June 25, 2019
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: September 29, 2021
• Results First Posted: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)