Back to resultsAssessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
Primary Purpose
Type 1 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
summerlunch+ At Home Food Skills Program
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes for over one year
Exclusion Criteria:
- Type 1 diabetes for less than one year, non-English speaking, do not have access to a computer or internet
Sites / Locations
- The Hospital for Sick ChildrenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
There will be one arm to the study, and all participants will be receiving the intervention.
Outcomes
Primary Outcome Measures
Feasibility and acceptability of the virtual summerlunch+At Home program
Questionnaire
Feasibility and acceptability of the virtual summerlunch+At Home program
Feasibility and acceptability of the virtual summerlunch+At Home program
Questionaire
Secondary Outcome Measures
The impact of the program on food literacy skills children's attitude towards cooking, cooking confidence, food knowledge and food preferences -
Questionnaire to measure the change in food literacy skills before and after the program.
Changes in glycemic control as measured through HbA1C levels
Routine blood work
Full Information
NCT ID
NCT05197114
First Posted
December 29, 2021
Last Updated
January 17, 2022
Sponsor
The Hospital for Sick Children
Collaborators
Toronto Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT05197114
Brief Title
Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
Official Title
Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2022 (Anticipated)
Primary Completion Date
March 25, 2022 (Anticipated)
Study Completion Date
September 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Toronto Metropolitan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Food forms an integral part of diabetes management. As children mature into young adults, they must learn to adopt lifestyle behaviours critical for optimal diabetes care. The development of food preparation and cooking skills at a young age may help to facilitate healthy food choices in children and provide a solid foundation for young adulthood. Food skills workshops are effective interventions that have been shown to improve food literacy and healthy eating in the general pediatric population. However, food skills programs have not been adequately evaluated in children with type 1 diabetes. Further, virtual programs are not well assessed, which can increase the accessibility of food education during the pandemic and in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
There will be one arm to the study, and all participants will be receiving the intervention.
Intervention Type
Other
Intervention Name(s)
summerlunch+ At Home Food Skills Program
Intervention Description
The summerlunch+ At Home program a virtual eight-week food skills program that teaches cooking, nutrition and environmental sustainability to children. The program has been adapted for those with Type 1 Diabetes to teach important food skills specific to diabetes management.
Primary Outcome Measure Information:
Title
Feasibility and acceptability of the virtual summerlunch+At Home program
Description
Questionnaire
Time Frame
Two months
Title
Feasibility and acceptability of the virtual summerlunch+At Home program
Time Frame
Three months
Title
Feasibility and acceptability of the virtual summerlunch+At Home program
Description
Questionaire
Time Frame
Six months
Secondary Outcome Measure Information:
Title
The impact of the program on food literacy skills children's attitude towards cooking, cooking confidence, food knowledge and food preferences -
Description
Questionnaire to measure the change in food literacy skills before and after the program.
Time Frame
Two months, three months and six months
Title
Changes in glycemic control as measured through HbA1C levels
Description
Routine blood work
Time Frame
Two months, three months and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes for over one year
Exclusion Criteria:
Type 1 diabetes for less than one year, non-English speaking, do not have access to a computer or internet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanita Pais
Phone
4168135745
Email
Vanita.Pais@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Goldstein
Phone
4379934018
Email
sarah.goldstein@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanita Pais
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanita Pais
Phone
4168135745
Email
vanita.pais@sickkids.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
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