Carbohydrate Counting and Type 1 Diabetes: A Randomized Controlled Trial of Internet-based Teaching for Adolescents Learning to Count
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: In-person Carbohydrate Counting Class (Behavioral)
Internet-Based Teaching
This group of adolescents will receive carbohydrate counting instruction through an online teaching tutorial.
Intervention: Online Carbohydrate Counting Tutorial (Behavioral)
Outcomes
Primary Outcomes
Change in Carbohydrate Counting Accuracy Measured Using a Standardized Meal & Snack Tray Test at Baseline and 3-months Post-Education
Time Frame: 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.
Secondary Outcomes
- Change in Carbohydrate Counting Knowledge Tested Using the PedCarbQuiz (PCQ) at Baseline and 3-months Post-Education(Baseline; 3-months post-education)
Investigators
Jill Hamilton
Senior Associate Scientist
The Hospital for Sick Children