A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions
Phase: NA
Conditions: Kidney Failure, Quality of Life, Fluid Restriction, Interdialytic Weight Gain, Hemodialysis, Mindfulness
Sponsor: University of Texas at Austin

 
 
A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients with Fluid Restrictions  
 
 
NCT #04016311  
 
 
2/20/2019  
 
 

Study Protocol:  
1. Randomize into intervention or control group by cohort days (M-W-F or T-TH-Sa).  
2. Dialysis staff will identify patients that meet inclusion and exclusion criteria for the targeted 
dialysis session (sessions in which one of the researchers is available to attend) and ask if they 
are interested in talking to a researcher about participating in a research study.  
3. Research staff will talk to interested patients about the study as part of the consent process 
and obtain written, informed consent.  
4. All participants will fill out questionnaires (e.g., Background Information, Kidney Disease 
Quality of Life, Renal Adherence Behavior Questionnaire, Mindful Eating Questionnaire).        
For participants in the intervention group only (items 5-15):  
5. Researcher will introduce the idea about mindful drinking and eating activities and guide the 
participant through mindful eating of frozen grapes and mindful drinking of water.  
6. Researcher will discuss the experience with the participant.  
7. Researcher will provide directions for practicing mindful drinking/eating at home and review 
the activity checklist.  
8. During week 2, the researcher will guide the participant through mindful eating of frozen 
blueberries and mindful drinking with cold juice, followed by a discussion of the experience.  
9. The weekly activity checklist will be collected, and researcher and participant will discuss how 
the mindful drinking/eating practice went at home along with problem solving any barriers that 
occurred.  
10. During week 3, the researcher will guide the participant through mindful eating of hard candy 
and mindful drinking of a hot liquid, followed by discussion of the experience.  
11. The weekly activity checklist will be collected, and the researcher and participant will discuss 
how the mindful drinking/eating practice at home went along with problem solving any barriers 
that occurred.  
12. During week 4, the researcher will guide the participant through mindful eating of a popsicle 
and mindful drinking of water with lemon, followed by discussion of the experience.  
13. The weekly activity checklist will be collected, and the researcher and participant will 
discuss: how the mindful drinking/eating practice went at home, how to handle any barriers that 
occurred, and goals for continuing mindful eating/drinking into the future.  
14. At week 4, all participants will fill out post-intervention questionnaires (e.g., Exit 
Questionnaire, Kidney Disease Quality of Life, Renal Adherence Behavior Questionnaire 
Mindful Eating Questionnaire).  
15. The researcher will ask for feedback from those in the intervention group about the 
interventions sessions and home practice using an Exit interview guide. Answers will be 
recorded in writing.  

16. The researcher receive data from participants’ electronic health record (e.g., pre- and post-
intervention interdialytic weight gain) from dialysis staff.  
17. Wait list control group receives same intervention described in steps 5-15 at the completion 
of the intervention. (OPTIONAL)  
 
Statistical Analysis Plan: This is a small, exploratory pilot study. Data will be analyzed using 
descriptive statistics to describe the sample and the measures. Differences between pre- and 
post- intervention measures will be examined using paired t-tests for each arm of the study.