Trial Outcomes & Findings for A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions (NCT NCT04016311)
NCT ID: NCT04016311
Last Updated: 2021-09-29
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
4 weeks
Results posted on
2021-09-29
Participant Flow
Recruited from 2 dialysis centers. Assigned randomly by cohort (Tues/Thurs/Sat dialysis patients vs Monday/Wed/Friday) to prevent contamination.
Participant milestones
| Measure |
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.
|
Wait List Control
Usual treatment - offered intervention after completion of post-test data collection.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
17
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Wait List Control
Usual treatment - offered intervention after completion of post-test data collection.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Baseline for study measures does not include the participant that withdrew
Baseline characteristics by cohort
| Measure |
Mindful Drinking/Eating Group
n=18 Participants
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.
|
Wait List Control
n=20 Participants
Usual treatment - offered intervention after completion of post-test data collection.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=18 Participants
|
9 Participants
n=20 Participants
|
18 Participants
n=38 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=18 Participants
|
11 Participants
n=20 Participants
|
20 Participants
n=38 Participants
|
|
Age, Continuous
|
61.56 years
STANDARD_DEVIATION 13.85 • n=18 Participants
|
61.50 years
STANDARD_DEVIATION 15.44 • n=20 Participants
|
61.53 years
STANDARD_DEVIATION 14.51 • n=38 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=18 Participants
|
7 Participants
n=20 Participants
|
12 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=18 Participants
|
13 Participants
n=20 Participants
|
26 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=18 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=18 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=38 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=18 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=38 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=18 Participants
|
12 Participants
n=20 Participants
|
21 Participants
n=38 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=38 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
20 participants
n=20 Participants
|
38 participants
n=38 Participants
|
|
Total score Kidney Disease Quality of Life -36 SF
|
68.64 units on a scale
STANDARD_DEVIATION 15.12 • n=17 Participants • Baseline for study measures does not include the participant that withdrew
|
63.92 units on a scale
STANDARD_DEVIATION 14.91 • n=20 Participants • Baseline for study measures does not include the participant that withdrew
|
66.09 units on a scale
STANDARD_DEVIATION 14.99 • n=37 Participants • Baseline for study measures does not include the participant that withdrew
|
|
Interdialytic Weight Gain
|
2.46 kilograms
STANDARD_DEVIATION 1.10 • n=17 Participants • Baseline data was analyzed without the data from the participant that withdrew.
|
2.52 kilograms
STANDARD_DEVIATION 1.10 • n=20 Participants • Baseline data was analyzed without the data from the participant that withdrew.
|
2.49 kilograms
STANDARD_DEVIATION 1.07 • n=37 Participants • Baseline data was analyzed without the data from the participant that withdrew.
|
|
Mindful Eating Questionnaire
|
3.08 units on a scale
STANDARD_DEVIATION 0.32 • n=17 Participants • Baseline measure was analyzed without data from the subject that withdrew.
|
2.94 units on a scale
STANDARD_DEVIATION 0.23 • n=20 Participants • Baseline measure was analyzed without data from the subject that withdrew.
|
3.00 units on a scale
STANDARD_DEVIATION 0.28 • n=37 Participants • Baseline measure was analyzed without data from the subject that withdrew.
|
PRIMARY outcome
Timeframe: 4 weeksTotal Score for Kidney-Disease Quality of Life Short Form v1.3 Higher scores indicate greater quality of life. Score range from 0 to 100
Outcome measures
| Measure |
Mindful Drinking/Eating Group
n=18 Participants
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.
|
Wait List Control
n=20 Participants
Usual treatment - offered intervention after completion of post-test data collection.
|
|---|---|---|
|
Total Score for Kidney-Disease Quality of Life Short Form v1.3
|
69.66 score on a scale
Standard Deviation 15.79
|
66.12 score on a scale
Standard Deviation 13.24
|
PRIMARY outcome
Timeframe: 4 weeksAverage 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.
Outcome measures
| Measure |
Mindful Drinking/Eating Group
n=17 Participants
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.
|
Wait List Control
n=20 Participants
Usual treatment - offered intervention after completion of post-test data collection.
|
|---|---|---|
|
Interdialytic Weight Gain (IWG)
|
2.86 kilograms
Standard Deviation 1.51
|
2.46 kilograms
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 4 weeksTotal score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating.
Outcome measures
| Measure |
Mindful Drinking/Eating Group
n=17 Participants
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.
|
Wait List Control
n=20 Participants
Usual treatment - offered intervention after completion of post-test data collection.
|
|---|---|---|
|
Mindful Eating
|
3.12 score on a scale
Standard Deviation 0.26
|
3.03 score on a scale
Standard Deviation 0.30
|
Adverse Events
Mindful Drinking/Eating Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Wait List Control
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mindful Drinking/Eating Group
n=18 participants at risk
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.
|
Wait List Control
n=20 participants at risk
Usual care. Intervention offered after post-test data collected.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hospitalized for fall
|
5.6%
1/18 • Number of events 1 • Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
|
0.00%
0/20 • Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
|
|
Surgical and medical procedures
Hospitalized for surgery
|
0.00%
0/18 • Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
|
5.0%
1/20 • Number of events 1 • Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
|
|
Blood and lymphatic system disorders
Blood clot
|
0.00%
0/18 • Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
|
5.0%
1/20 • Number of events 1 • Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
|
Other adverse events
Adverse event data not reported
Additional Information
Gayle M. Timmerman PhD, Professor
The University of Texas at Austin, School of Nursing
Phone: 5124719087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place