Type 1 DiabetesNCT05197114
Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
A study testing summerlunch+ At Home Food Skills Program in people with Type 1 Diabetes, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- summerlunch+ At Home Food Skills Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2022to 25 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Type 1 diabetes for over one year
Who cannot join
- Type 1 diabetes for less than one year, non-English speaking, do not have access to a computer or internet
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
Vanita Pais, 4168135745, vanita.pais@sickkids.ca
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- summerlunch+ At Home Food Skills Program
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
summerlunch+ At Home Food Skills ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | There will be one arm to the study, and all participants will be receiving the intervention. Receives: Other: summerlunch+ At Home Food Skills Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the virtual summerlunch+At Home program
Questionnaire
Measured: Two months
Feasibility and acceptability of the virtual summerlunch+At Home program
Measured: Three months
Feasibility and acceptability of the virtual summerlunch+At Home program
Questionaire
Measured: Six months
Secondary outcomes (2)
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.
Measured: Two months, three months and six months
Changes in glycemic control as measured through HbA1C levels
Routine blood work
Measured: Two months, three months and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start25 Jan 2022 (estimated)
- Primary completion25 Mar 2022 (estimated)
- Study completion25 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University
- Responsible party
- Principal investigator, Vanita Pais, The Hospital for Sick Children
- Investigators
- Vanita Pais, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197114
- Sponsor's protocol ID
- 1000076894
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
- ClinicalTrials.gov ID
- NCT05197114
- Acronym / sponsor ID
- 1000076894
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University
- Study start
- 25 Jan 2022 (estimated)
- Primary completion
- 25 Mar 2022 (estimated)
- Study completion
- 25 Sep 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: summerlunch+ At Home Food Skills ProgramThere will be one arm to the study, and all participants will be receiving the intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Type 1 diabetes for over one year
Key exclusion criteria (1 listed)
- Type 1 diabetes for less than one year, non-English speaking, do not have access to a computer or internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| summerlunch+ At Home Food Skills ProgramThe 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. | Other | Intervention |
Primary outcome
Feasibility and acceptability of the virtual summerlunch+At Home program
Time frame: Two months
Questionnaire
Feasibility and acceptability of the virtual summerlunch+At Home program
Time frame: Three months
Feasibility and acceptability of the virtual summerlunch+At Home program
Time frame: Six months
Questionaire
2 secondary outcomes
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
Changes in glycemic control as measured through HbA1C levels
Time frame: Two months, three months and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanita Pais principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing summerlunch+ At Home Food Skills Program in people with Type 1 Diabetes, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanita Pais (4168135745, Vanita.Pais@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the virtual summerlunch+At Home program (time frame: Two months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.