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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Wait list control | No Intervention | Usual care. Offered intervention after post-test data collected. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mindful Eating | Total score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Austin | Austin | Texas | 78712 | United States |
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Recruited from 2 dialysis centers. Assigned randomly by cohort (Tues/Thurs/Sat dialysis patients vs Monday/Wed/Friday) to prevent contamination.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2019 |
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Intervention and wait list control groups with rolling admission.
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| FG001 | Wait List Control | Usual treatment - offered intervention after completion of post-test data collection. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Wait List Control | Usual treatment - offered intervention after completion of post-test data collection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total score Kidney Disease Quality of Life -36 SF | Baseline for study measures does not include the participant that withdrew | Mean | Standard Deviation | units on a scale |
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| Interdialytic Weight Gain | Baseline data was analyzed without the data from the participant that withdrew. | Mean | Standard Deviation | kilograms |
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| Mindful Eating Questionnaire | Baseline measure was analyzed without data from the subject that withdrew. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| 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 | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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| 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. | Posted | Mean | Standard Deviation | kilograms | 4 weeks |
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| Secondary | Mindful Eating | Total score on Mindful Eating Questionnaire Total Scores range from 1 to 4. Higher scores indicate more mindful eating. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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Adverse events were tracked from pre-test to post-test per participant over the 4 weeks that they were enrolled in study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 18 | 1 | 18 | 0 | 18 |
| EG001 | Wait List Control | Usual care. Intervention offered after post-test data collected. | 0 | 20 | 2 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Hospitalized for fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Hospitalized for surgery | Surgical and medical procedures | Non-systematic Assessment | Pacemaker and Heart valve replacement surgery |
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| Blood clot | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayle M. Timmerman PhD, Professor | The University of Texas at Austin, School of Nursing | 5124719087 | gtimmerman@mail.utexas.edu |
| Sep 1, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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