- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05197114
Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
January 17, 2022 updated by: Vanita Pais, The Hospital for Sick Children
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vanita Pais
- Phone Number: 4168135745
- Email: vanita.pais@sickkids.ca
Study Contact Backup
- Name: Sarah Goldstein
- Phone Number: 4379934018
- Email: sarah.goldstein@sickkids.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X8
- Recruiting
- The Hospital for Sick Children
-
Contact:
- Vanita Pais
- Phone Number: 4168135745
- Email: vanita.pais@sickkids.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
There will be one arm to the study, and all participants will be receiving the intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and acceptability of the virtual summerlunch+At Home program
Time Frame: Two months
|
Questionnaire
|
Two months
|
Feasibility and acceptability of the virtual summerlunch+At Home program
Time Frame: Three months
|
Three months
|
|
Feasibility and acceptability of the virtual summerlunch+At Home program
Time Frame: Six months
|
Questionaire
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The impact of the program on food literacy skills children's attitude towards cooking, cooking confidence, food knowledge and food preferences -
Time Frame: Two months, three months and six months
|
Questionnaire to measure the change in food literacy skills before and after the program.
|
Two months, three months and six months
|
Changes in glycemic control as measured through HbA1C levels
Time Frame: Two months, three months and six months
|
Routine blood work
|
Two months, three months and six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vanita Pais, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 25, 2022
Primary Completion (Anticipated)
March 25, 2022
Study Completion (Anticipated)
September 25, 2022
Study Registration Dates
First Submitted
December 29, 2021
First Submitted That Met QC Criteria
January 17, 2022
First Posted (Actual)
January 19, 2022
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 17, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000076894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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