跳至主要内容
临床试验/NCT04016311
NCT04016311已完成不适用

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

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Interdialytic Weight Gain (IWG)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Receiving hemodialysis
  • •Able to speak English

排除标准

  • •Missed more than one dialysis treatment in the past month

研究组 & 干预措施

Wait list control

No Intervention

Usual care. Offered intervention after post-test data collected.

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.

干预措施: Mindful Drinking/Eating Intervention (Behavioral)

结局指标

主要结局

Interdialytic Weight Gain (IWG)

时间窗: 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.

Total Score for Kidney-Disease Quality of Life Short Form v1.3

时间窗: 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

次要结局

  • Mindful Eating(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gayle Timmerman,

Associate Professor

University of Texas at Austin

研究点 (1)

Loading locations...

相似试验