A Mindfulness-based Intervention for Adolescents With Prediabetes or Type 2 Diabetes
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
- Participation
研究概览
简要总结
The purpose of this study is to conduct a mindfulness-based intervention for adolescents referred for prediabetes or type 2 diabetes treatment to 1) evaluate feasibility and acceptability of the intervention for future research and clinical use and 2) explore secondary health outcomes related to diabetes prevention and care.
详细描述
Background and Rationale Mindfulness-based interventions (MBI) may offer additional benefits to traditional health care for youth living with prediabetes or T2D. MBIs teach skills to increase present moment attention and adopt a nonjudgmental attitude towards one's experience which can foster healthy stress coping behaviors and greater self-regulation; both of which are associated with improved diabetes self-care behaviors. MBIs were introduced to the clinical population in the 1970's and have been translated for a variety of populations and health conditions including diabetes. MBIs may be a promising complementary approach for T2D prevention and treatment in youth, and thus, warrant further investigation.
Specific Aims Aim 1: Pilot test the feasibility and acceptability of a mindfulness-based intervention in adolescents with prediabetes or type 2 diabetes.
Aim 2: Explore secondary physical and mental health outcomes of the study cohorts.
Enrollment The investigators aim to recruit 50 individuals with the goal of at least 20 participants to complete the study (two groups of 10 participants).
Recruitment Sites: Diabetes care providers see patients in an outpatient setting at Riley Specialty Care at IU Health Methodist in Indianapolis, Indiana. Additional outreach clinics available for participant recruitment include Riley Specialty Care at Riley Outpatient Center, IU North, Bloomington, Fort Wayne, and South Bend.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-18 years
- •Referred to clinic for treatment of prediabetes or type 2 diabetes
- •English speaking
排除标准
- •• Diagnosed cognitive disabilities
- •Inability to attend visits due to individual schedules
结局指标
主要结局
Participation
时间窗: 3 months
Study Participation Rate: Number of participants who consented to take part in the study divided by the number of patients approached. We will also document reasons for refusal to participate in the study.
Acceptability
时间窗: 12 months
L2B Program Questionnaires Post-study guided interview: 1. What did you like about participating in this study? 2. What did you dislike about participating in this study? 3. What were your expectations from participating in this study? 4. Were those expectations met?
Recruitment
时间窗: 3 months
Time to Recruit: Time required to attain the needed sample for each recruitment wave
Attendance
时间窗: 4 months
Attendance: Attendance at each intervention session will be recorded.
Retention
时间窗: 12 months
Study Retention Rate: Number of participants in a study arm who remain in the study and maintain communication with study staff (regardless of session attendance) divided by the number of participants enrolled in the study.
Completion
时间窗: 12 months
Study Completion Rate: Number of participants who complete all assessments divided by the number of participants enrolled in the study arm.
Data Completeness
时间窗: 12 months
Data Completeness: Percentage of questionnaires/study measures completed.
次要结局
- Height from electronic medical record(12 months)
- HbA1c from electronic medical record(12 months)
- Weight from the electronic medical record(12 months)
研究者
Tamara S. Hannon
Professor of Pediatrics
Indiana University