A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions
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 |
---|---|---|
|
N/A |
Study Design
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
- 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
- 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
- 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
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.- 2019-01-0074
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
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)
|
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)
|
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
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 |
gtimmerman@mail.utexas.edu |
- 2019-01-0074