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Finding the Patient's Voice Diabetes Prevention Programs

2019年8月5日 更新者:Tamara S. Hannon、Indiana University

Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs

This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.

研究概览

地位

完全的

详细说明

Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:

  1. helping youth/families understand the importance of prevention,
  2. on-going interest and participation, and
  3. differing personal beliefs.

Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.

研究类型

介入性

注册 (实际的)

146

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Indiana
      • Carmel、Indiana、美国、46032
        • Riley Children's Specialties
      • Indianapolis、Indiana、美国、46202
        • Indiana University School of Medicine
      • Indianapolis、Indiana、美国、46202
        • Riley Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
  2. At least two of the following risk factors:

    • Have been diagnosed with prediabetes;
    • Have a family history of T2DM in first- and second-degree relatives;
    • Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
    • Have conditions associated with insulin resistance; and/or
    • Have had gestational diabetes or were exposed to gestational diabetes in utero.
  3. A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).

Exclusion Criteria:

1. Type 2 diagnosis

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
大体时间:12 months
12 months

次要结果测量

结果测量
措施说明
大体时间
Hemoglobin A1C
大体时间:12 months
12 months
Physical activity
大体时间:12 months
self-report
12 months
Quality of life
大体时间:12 months
Pediatric Quality of Life Inventory
12 months
Intervention group session attendance
大体时间:12 months
12 months
Dietary records
大体时间:12 months
Semi-quantitative food frequency questionniare
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tamara Hannon, MD、Indiana University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年11月1日

初级完成 (实际的)

2019年6月1日

研究完成 (实际的)

2019年6月1日

研究注册日期

首次提交

2016年2月23日

首先提交符合 QC 标准的

2016年3月1日

首次发布 (估计)

2016年3月7日

研究记录更新

最后更新发布 (实际的)

2019年8月7日

上次提交的符合 QC 标准的更新

2019年8月5日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

undecided

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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