Fluid Restriction, Hemodialysis, Interdialytic Weight Gain, Kidney Failure, Mindfulness, Quality of Life
Conditions
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.
Interventions
BEHAVIORALMindful 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.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intervention and wait list control groups with rolling admission.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receiving hemodialysis * Able to speak English
Exclusion criteria
* Missed more than one dialysis treatment in the past month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mindful Eating | 4 weeks | Total score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Mindful Drinking/Eating Group 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. | 18 |
| Wait List Control Usual treatment - offered intervention after completion of post-test data collection. | 20 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Mindful Drinking/Eating Group | Total | Wait List Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 20 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Continuous | 61.56 years STANDARD_DEVIATION 13.85 | 61.53 years STANDARD_DEVIATION 14.51 | 61.50 years STANDARD_DEVIATION 15.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 18 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Interdialytic Weight Gain | 2.46 kilograms STANDARD_DEVIATION 1.1 | 2.49 kilograms STANDARD_DEVIATION 1.07 | 2.52 kilograms STANDARD_DEVIATION 1.1 |
| Mindful Eating Questionnaire | 3.08 units on a scale STANDARD_DEVIATION 0.32 | 3.00 units on a scale STANDARD_DEVIATION 0.28 | 2.94 units on a scale STANDARD_DEVIATION 0.23 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 21 Participants | 12 Participants |
| Region of Enrollment United States | 18 participants | 38 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
| Total score Kidney Disease Quality of Life -36 SF | 68.64 units on a scale STANDARD_DEVIATION 15.12 | 66.09 units on a scale STANDARD_DEVIATION 14.99 | 63.92 units on a scale STANDARD_DEVIATION 14.91 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 0 / 18 | 0 / 20 |
| serious Total, serious adverse events | 1 / 18 | 2 / 20 |
Outcome results
Primary
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindful Drinking/Eating Group | Interdialytic Weight Gain (IWG) | 2.86 kilograms | Standard Deviation 1.51 |
| Wait List Control | Interdialytic Weight Gain (IWG) | 2.46 kilograms | Standard Deviation 0.97 |
Primary
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
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindful Drinking/Eating Group | Total Score for Kidney-Disease Quality of Life Short Form v1.3 | 69.66 score on a scale | Standard Deviation 15.79 |
| Wait List Control | Total Score for Kidney-Disease Quality of Life Short Form v1.3 | 66.12 score on a scale | Standard Deviation 13.24 |
Secondary
Mindful Eating
Total score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindful Drinking/Eating Group | Mindful Eating | 3.12 score on a scale | Standard Deviation 0.26 |
| Wait List Control | Mindful Eating | 3.03 score on a scale | Standard Deviation 0.3 |