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

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Failure, Quality of Life, Fluid Restriction, Interdialytic Weight Gain, Hemodialysis, Mindfulness

Intervention / Treatment
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* Behavioral: Mindful Drinking/Eating Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving hemodialysis Able to speak English Exclusion Criteria: Missed more than one dialysis treatment in the past month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention and wait list control groups with rolling admission.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Drinking/Eating Group<br>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<br>* 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.<br>|
| No Intervention: Wait list control<br>Usual care. Offered intervention after post-test data collected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |