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临床试验/NCT07270900
NCT07270900
已完成
不适用

A Mindfulness-based Intervention for Adolescents With Prediabetes or Type 2 Diabetes

Indiana University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月1日最近更新:

概览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Participation

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.

Study Procedures Following enrollment, participants will complete baseline surveys and begin attending the 12-week MBI. Participants will complete surveys following completion of the MBI and at the 12-month follow up.

Intervention The MBI will be conducted in a virtual group setting by Zoom, with a target size of 8-12 participants. Groups may vary in size based on session attendance. The MBI will follow the Learning to BREATHE (L2B) curriculum. L2B is a manualized 12-week curriculum that teaches a variety of mindfulness skills including breath awareness, body scanning, mindful eating, sitting meditation, loving kindness practice, and mindful movement. Weekly group sessions will last 45-60 minutes. Participants will be invited to engage in daily practice of mindfulness skills (home practice). This study includes a post-intervention group guided interview at 12-weeks. The facilitator will ask the group for feedback about the intervention with the following questions: 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?

The investigators will describe the results of participants using quantitative data (results of surveys and numerical clinical information from HbA1c and BMI) and qualitative data (results from interviews).

This study will be important to serve as the foundation for a fully powered clinical trial of MBI in type 2 diabetes and prediabetes.

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

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

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 (1)

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