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临床试验/NCT05577169
NCT05577169已完成不适用

Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes

Indiana University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月14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
30
试验地点
2
主要终点
Acceptability of intervention in the study population.

研究概览

简要总结

Adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. The purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.

详细描述

This is a pilot study to learn if adding mind-body skills to diabetes education is useful in helping adolescents manage their type 1 diabetes. Specifically, the investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an A1c >9.0% who have also had the diagnosis of diabetes for at least 12 months. This study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. The investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. Sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. The study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. Participants will continue to attend their regular diabetes clinic appointments every three months. At the end of the study, participants will also partake in a short interview to gather feedback about their experience. The goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.

研究设计

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

入排标准

年龄范围
15 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 15-17 years
  • •Diagnosis of type 1 diabetes for at least 12 months
  • •Uncontrolled diabetes with A1c at least 9.0%
  • •Parent or guardian agrees for adolescent to participate

排除标准

  • •Diagnosed cognitive disabilities
  • •Other uncontrolled chronic diseases as assessed by PI
  • •Inability to attend visits due to individual schedules

研究组 & 干预措施

Mind-body skills + diabetes education

Experimental

Participants randomly assigned to this arm will undergo 20-30 minutes discussing a predetermined diabetes topic followed by 20-30 minutes working on a mind-body skills component. This mind-body skills component will be a combination of deep breathing, self-reflection, and meditation techniques focused on self-awareness to calm the stress-response. Participants will be assigned "homework" designed to encourage practice of the learned skill.

干预措施: Mind-body skills (Behavioral)

Mind-body skills + diabetes education

Experimental

Participants randomly assigned to this arm will undergo 20-30 minutes discussing a predetermined diabetes topic followed by 20-30 minutes working on a mind-body skills component. This mind-body skills component will be a combination of deep breathing, self-reflection, and meditation techniques focused on self-awareness to calm the stress-response. Participants will be assigned "homework" designed to encourage practice of the learned skill.

干预措施: Diabetes education (Behavioral)

Diabetes education alone

Active Comparator

Participants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group.

干预措施: Diabetes education (Behavioral)

结局指标

主要结局

Acceptability of intervention in the study population.

时间窗: 12 months

This will be measured by participant satisfaction surveys.

Feasibility of intervention in the study population.

时间窗: 12 months

Feasibility of recruitment, retention of participants, and intervention completion. This will be measured by considering study participation rate, time to recruit, attendance, study retention rate, study completion rate, participant burden, and data completeness.

次要结局

  • Hemoglobin A1c (HbA1c, %)(12 months)

研究者

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

Tamara S. Hannon

Professor of Pediatrics

Indiana University

研究点 (2)

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