NCT05197114

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

January 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

December 29, 2021

Last Update Submit

January 17, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Feasibility and acceptability of the virtual summerlunch+At Home program

    Questionnaire

    Two months

  • Feasibility and acceptability of the virtual summerlunch+At Home program

    Three months

  • Feasibility and acceptability of the virtual summerlunch+At Home program

    Questionaire

    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 -

    Two months, three months and six months

  • Changes in glycemic control as measured through HbA1C levels

    Two months, three months and six months

Study Arms (1)

Intervention

EXPERIMENTAL

There will be one arm to the study, and all participants will be receiving the intervention.

Other: summerlunch+ At Home Food Skills Program

Interventions

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.

Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Type 1 diabetes for over one year

You may not qualify if:

  • Type 1 diabetes for less than one year, non-English speaking, do not have access to a computer or internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Vanita Pais

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Dietitian

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 19, 2022

Study Start

January 25, 2022

Primary Completion

March 25, 2022

Study Completion

September 25, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations