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Families Preventing Diabetes Together

2017年8月23日 更新者:University of Minnesota
The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

研究概览

详细说明

The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.

Adult patients and their families will be recruited in two ways:

  1. from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
  2. through MyChart messages informing them about the study.

Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

研究类型

介入性

注册 (实际的)

7

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

    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota, School of Nursing

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

2年 至 55年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Parent with Type 2 diabetes
  • At least 1 child between the ages of 7-12
  • Parent has completed at least some Diabetes Education through Fairview Health System

Exclusion Criteria:

  • Parent with Type 2 diabetes does not speak or read in English
  • No parents with Type 2 diabetes or no children ages 7-12 years
  • Parent with Type 2 diabetes has not completed at least some Diabetes Education

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:随机化
  • 介入模型:并行分配
  • 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 Group
Families in the Families Preventing Diabetes Together intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
Families in the intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
无干预:Measurement Only
No intervention only measurements

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
大体时间:up to 6 months
Ability to successfully recruit 30- 40 families in the study will determine feasibility.
up to 6 months
Feasibility of the study measured via the ability to successfully measure 100% of the adults and 80% of the children in enrolled families at baseline measurements.
大体时间:up to 6 months
Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
up to 6 months
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
大体时间:up to 6 months
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
up to 6 months
Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
大体时间:up to 6 months
Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
up to 6 months
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
大体时间:up to 6 months
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
up to 6 months

次要结果测量

结果测量
措施说明
大体时间
Child BMIz
大体时间:up to 6 months
Objectively measured height and weight will be used to determine child BMIz values to see if the study resulted in any changes in BMIz between baseline measurements and post-intervention measurements.
up to 6 months
Blood glucose control in parent with Type 2 diabetes
大体时间:up to 6 months
Change in type 2 diabetic parent's A1C values over the course of the study will be used to measure parent blood glucose control between baseline measurements and post-intervention measurements.
up to 6 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。

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

2016年2月1日

初级完成 (实际的)

2017年6月30日

研究完成 (实际的)

2017年6月30日

研究注册日期

首次提交

2016年2月16日

首先提交符合 QC 标准的

2016年3月28日

首次发布 (估计)

2016年3月29日

研究记录更新

最后更新发布 (实际的)

2017年8月24日

上次提交的符合 QC 标准的更新

2017年8月23日

最后验证

2017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)?

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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