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

Sponsor
University of Texas at Austin (Other)
Overall Status
Completed
CT.gov ID
NCT04016311
Collaborator
(none)
38
1
2
10.4
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindful Drinking/Eating Intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Intervention and wait list control groups with rolling admission.Intervention and wait list control groups with rolling admission.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions
Actual Study Start Date :
Jun 25, 2019
Actual Primary Completion Date :
May 7, 2020
Actual Study Completion Date :
May 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: Wait list control

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Secondary Outcome Measures

  1. Mindful Eating [4 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Receiving hemodialysis

  • Able to speak English

Exclusion Criteria:
  • Missed more than one dialysis treatment in the past month

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas at Austin Austin Texas United States 78712

Sponsors and Collaborators

  • University of Texas at Austin

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Gayle Timmerman,, Associate Professor, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT04016311
Other Study ID Numbers:
  • 2019-01-0074
First Posted:
Jul 11, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Recruited from 2 dialysis centers. Assigned randomly by cohort (Tues/Thurs/Sat dialysis patients vs Monday/Wed/Friday) to prevent contamination.
Pre-assignment Detail
Arm/Group Title Mindful Drinking/Eating Group Wait List Control
Arm/Group Description 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 treatment - offered intervention after completion of post-test data collection.
Period Title: Overall Study
STARTED 18 20
COMPLETED 17 20
NOT COMPLETED 1 0

Baseline Characteristics

Arm/Group Title Mindful Drinking/Eating Group Wait List Control Total
Arm/Group Description 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 treatment - offered intervention after completion of post-test data collection. Total of all reporting groups
Overall Participants 18 20 38
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
9
50%
9
45%
18
47.4%
>=65 years
9
50%
11
55%
20
52.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
61.56
(13.85)
61.50
(15.44)
61.53
(14.51)
Sex: Female, Male (Count of Participants)
Female
5
27.8%
7
35%
12
31.6%
Male
13
72.2%
13
65%
26
68.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
8
44.4%
10
50%
18
47.4%
Not Hispanic or Latino
9
50%
10
50%
19
50%
Unknown or Not Reported
1
5.6%
0
0%
1
2.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
1
5%
1
2.6%
Native Hawaiian or Other Pacific Islander
0
0%
1
5%
1
2.6%
Black or African American
7
38.9%
6
30%
13
34.2%
White
9
50%
12
60%
21
55.3%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
2
11.1%
0
0%
2
5.3%
Region of Enrollment (participants) [Number]
United States
18
100%
20
100%
38
100%
Total score Kidney Disease Quality of Life -36 SF (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
68.64
(15.12)
63.92
(14.91)
66.09
(14.99)
Interdialytic Weight Gain (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]
2.46
(1.10)
2.52
(1.10)
2.49
(1.07)
Mindful Eating Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
3.08
(0.32)
2.94
(0.23)
3.00
(0.28)

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mindful Drinking/Eating Group Wait List Control
Arm/Group Description 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 treatment - offered intervention after completion of post-test data collection.
Measure Participants 18 20
Mean (Standard Deviation) [score on a scale]
69.66
(15.79)
66.12
(13.24)
2. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mindful Drinking/Eating Group Wait List Control
Arm/Group Description 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 treatment - offered intervention after completion of post-test data collection.
Measure Participants 17 20
Mean (Standard Deviation) [kilograms]
2.86
(1.51)
2.46
(0.97)
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Mindful Drinking/Eating Group Wait List Control
Arm/Group 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. 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.
Measure Participants 17 20
Mean (Standard Deviation) [score on a scale]
3.12
(0.26)
3.03
(0.30)

Adverse Events

Time Frame Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
Adverse Event Reporting Description
Arm/Group Title Mindful Drinking/Eating Group Wait List Control
Arm/Group Description 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. Intervention offered after post-test data collected.
All Cause Mortality
Mindful Drinking/Eating Group Wait List Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/18 (0%) 0/20 (0%)
Serious Adverse Events
Mindful Drinking/Eating Group Wait List Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/18 (5.6%) 2/20 (10%)
Blood and lymphatic system disorders
Blood clot 0/18 (0%) 0 1/20 (5%) 1
Injury, poisoning and procedural complications
Hospitalized for fall 1/18 (5.6%) 1 0/20 (0%) 0
Surgical and medical procedures
Hospitalized for surgery 0/18 (0%) 0 1/20 (5%) 1
Other (Not Including Serious) Adverse Events
Mindful Drinking/Eating Group Wait List Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/18 (0%) 0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Gayle M. Timmerman PhD, Professor
Organization The University of Texas at Austin, School of Nursing
Phone 5124719087
Email gtimmerman@mail.utexas.edu
Responsible Party:
Gayle Timmerman,, Associate Professor, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT04016311
Other Study ID Numbers:
  • 2019-01-0074
First Posted:
Jul 11, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021