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临床试验/NCT02462785
NCT02462785已完成不适用

Carbohydrate Counting and Type 1 Diabetes: A Randomized Controlled Trial of Internet-based Teaching for Adolescents Learning to Count

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年7月1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
48
试验地点
1
主要终点
Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education

研究概览

简要总结

Helping individuals with diabetes to control their blood sugars through self-management is an important goal, and counting carbohydrates (CHO) remains a key part of diabetes education and management. There is very little research examining CHO counting education with adolescents who have type 1 diabetes (T1DM). The purpose of this pilot study is to evaluate a newly developed internet-based teaching module of CHO counting for adolescents, ages 12-17 years, with T1DM and who do not regularly CHO count and require instruction. A secondary aim is to assess feasibility for a future, larger-scale clinical trail. An effective web-based CHO counting tutorial could be used to strengthen current diabetes education programs and may serve as a basis for developing other teaching modules. Advantages of web-based teaching include convenience, increased accessibility, and the ability to review and reinforce teaching concepts through repetition. It may also encourage adolescents to take the initiative for their own diabetes care, beginning with a self-directed, active learning experience.

研究设计

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

入排标准

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

入选标准

  • •Adolescents aged 12-17 years with a diagnosis of T1DM for more than 1 year
  • •Followed at the SickKids Diabetes Clinic
  • •Have access to a computer with Internet connection
  • •Able to communicate in English

排除标准

  • •Patients with type 2 diabetes, medication-induced diabetes or other forms of non T1DM
  • •Patients with Celiac disease, due to differences in prescribed dietary regimen
  • •Patients who are unable to communicate in English
  • •No computer or internet access
  • •Patient with cognitive delay impeding their ability to learn CHO counting
  • •Patients who have attended a CHO counting class within the past 6 months
  • •Patients who do not eat the foods presented on the planned meal & snack trays

研究组 & 干预措施

In-Class Instruction

Active Comparator

This group of adolescents will receive carbohydrate counting instruction through an in-person, in class session led by a registered dietician. This represents the usual standard of care at the Diabetes Clinic at The Hospital for Sick Children (SickKids).

干预措施: In-person Carbohydrate Counting Class (Behavioral)

Internet-Based Teaching

Experimental

This group of adolescents will receive carbohydrate counting instruction through an online teaching tutorial.

干预措施: Online Carbohydrate Counting Tutorial (Behavioral)

结局指标

主要结局

Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education

时间窗: Baseline; 3-months post-education

Test trays will comprise foods commonly consumed by adolescents (e.g., hamburger, grilled cheese sandwich). CHO counting accuracy using food trays will be checked against a computerized food analysis. Several tray combinations will be used with randomization to tray order within each group for both pre- and post- assessments.

次要结局

  • Change in Carbohydrate Counting Knowledge Tested Using the PedCarbQuiz (PCQ) at Baseline and 3-months Post-Education(Baseline; 3-months post-education)

研究者

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

Jill Hamilton

Senior Associate Scientist

The Hospital for Sick Children

研究点 (1)

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