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临床试验/NCT04702477
NCT04702477已完成不适用

An Innovative Approach With Group Counseling and Mindfulness Training Among Prediabetes Patients

Clemson University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年8月1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
19
试验地点
1
主要终点
Intervention Attendance

研究概览

简要总结

Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.

详细描述

This is a pilot study to examine the feasibility of integrating a mindfulness-based stress reduction (MBSR) intervention in addition to an existing group-based, peer supported clinical care model (JUMP) among patients with pre-diabetes or diabetes using a mixed-method design.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •18 years or older
  • •English speaking
  • •Having a diagnosis of diabetes or prediabetes
  • •Participation in a previous group-based clinical care model-JUMP (as in "JUMPing into Diabetes Control")

排除标准

  • •Under 18 years old
  • •Non-English Speaking
  • •not having a diagnosis of diabetes or prediabetes
  • •No participation in JUMP model

研究组 & 干预措施

Only Arm

Experimental

This is a single-arm, paired-sample pilot intervention study among participants with pre-diabetes or diabetes. Goal to integrate a MBSR intervention into a group-based, lifestyle intervention among patients with prediabetes or diabetes in the primary care setting

干预措施: Mindfulness Based Stress Reduction (Behavioral)

结局指标

主要结局

Intervention Attendance

时间窗: 8-weeks while completing the intervention

How many hours of intervention sessions an individual attended

次要结局

  • Depression(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • Medication Adherence(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • Perceived Stress Scale(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • Perceived Health Status(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • Physical Activity(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • Mindfulness(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • Program satisfaction and barriers for attending sessions(Immediately following intervention)
  • Anxiety(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • Sleep Quality(Up to 3 months before intervention, immediately following intervention, one month after intervention)
  • HbA1C levels(Up to 3 months before intervention, immediately following intervention, one month after intervention)

研究者

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

Heidi Zinzow

Professor of Psychology

Clemson University

研究点 (1)

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