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An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
In-person Carbohydrate Counting Class
Online Carbohydrate Counting Tutorial
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Adolescents, Carbohydrate Counting, Glycemic Control, Self-Management, T1DM

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Hospital for Sick Children (SickKids)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-Class Instruction

Internet-Based Teaching

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 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.

Secondary Outcome Measures

Change in Carbohydrate Counting Knowledge Tested Using the PedCarbQuiz (PCQ) at Baseline and 3-months Post-Education
A 52 item assessment of carbohydrate and insulin dose calculating knowledge in youth with T1DM

Full Information

First Posted
May 12, 2015
Last Updated
November 13, 2017
Sponsor
The Hospital for Sick Children
Collaborators
The Lawson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02462785
Brief Title
An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes
Official Title
Carbohydrate Counting and Type 1 Diabetes: A Randomized Controlled Trial of Internet-based Teaching for Adolescents Learning to Count
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
The Lawson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Adolescents, Carbohydrate Counting, Glycemic Control, Self-Management, T1DM

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-Class Instruction
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Internet-Based Teaching
Arm Type
Experimental
Arm Description
This group of adolescents will receive carbohydrate counting instruction through an online teaching tutorial.
Intervention Type
Behavioral
Intervention Name(s)
In-person Carbohydrate Counting Class
Intervention Description
An in-person carbohydrate counting class led by a registered dietician. The in class session covers topics including the role of CHO in nutrition and diabetes, sources of CHO, different CHO and non-CHO foods, resources for CHO counting, label reading, and meal planning. This is the standard procedure for CHO counting education at SickKids.
Intervention Type
Behavioral
Intervention Name(s)
Online Carbohydrate Counting Tutorial
Intervention Description
A web-based CHO counting tutorial that covers the same concepts reviewed during the standard in-person instructional session held at SickKids. A teen delivers the educational messages in short segments using techniques designed to maintain the viewer's attention (e.g., visuals of food portions and short segment highlights to emphasize important points). The online module includes brief interactive question/answer components for reinforcement. The secure online tutorial will be accessible for one week through a link provided by REDCap. Users will be able to repeat sessions, log on and off during sessions, and choose specific modules for repetition/review. The investigators will be able to capture the number of times patients log on and detail frequency and specifics of usage.
Primary Outcome Measure Information:
Title
Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education
Description
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.
Time Frame
Baseline; 3-months post-education
Secondary Outcome Measure Information:
Title
Change in Carbohydrate Counting Knowledge Tested Using the PedCarbQuiz (PCQ) at Baseline and 3-months Post-Education
Description
A 52 item assessment of carbohydrate and insulin dose calculating knowledge in youth with T1DM
Time Frame
Baseline; 3-months post-education

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Hamilton, MD, M.Sc.
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children (SickKids)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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An Evaluation of Internet-based Carbohydrate Counting Education for Adolescents With Type 1 Diabetes

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