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

NCT ID: NCT02462785

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Keywords

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Type 1 Diabetes Mellitus Adolescents Carbohydrate Counting Glycemic Control Self-Management T1DM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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In-Class Instruction

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).

Group Type ACTIVE_COMPARATOR

In-person Carbohydrate Counting Class

Intervention Type BEHAVIORAL

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.

Internet-Based Teaching

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

Group Type EXPERIMENTAL

Online Carbohydrate Counting Tutorial

Intervention Type BEHAVIORAL

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.

Interventions

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In-person Carbohydrate Counting Class

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

Online Carbohydrate Counting Tutorial

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Lawson Foundation

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Jill Hamilton

Senior Associate Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill Hamilton, MD, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000042623

Identifier Type: -

Identifier Source: org_study_id