NCT07780487

Brief Summary

Managing T1D requires a demanding regimen to keep blood sugars in control and stay healthy. Despite recent advances, this remains extremely challenging for children and their families, who usually report having the most difficulty with the healthy eating aspect of the management, sometimes more so than having to administer insulin or monitor sugar levels. In addition to high sugars, the rise in obesity in the last decades has contributed to the risk of long-term complications of T1D such as cardiovascular disease and renal failure. More than a third of youngsters with T1D are now overweight which makes the management of T1D much more challenging. The problem of obesity is much greater in the socially and economically disadvantaged groups as healthy eating is considered expensive. To educate kids with T1D and their families on healthy eating on a reasonable budget, in partnership with Phipps Conservatory's 5210 Let's Move Pittsburgh program, the investigators initiated virtual cooking classes during the early days of the COVID-19 pandemic. This proposal's objective is to start to evaluate the potential medical benefits as the investigators expand this program. The investigators expect the children who participate will show improvement in diabetes control, favorable decrease or maintenance of their weight and BMI when compared to their pre-intervention visit and to the control group, and improved knowledge about nutrition and healthy food choices when comparing pre- and post-intervention assessments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 4, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 7, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

Type 1 DiabetesNutritionCooking classesVirtual interventionAdolescentsDiabetes education

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin A1c

    Metric of glycemic control: change in HbA1c from pre- to post- intervention.

    From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.

Secondary Outcomes (4)

  • Change in Weight

    From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.

  • Change in BMI

    From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.

  • Change in dietary knowledge

    From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.

  • Change in food quality and quantity

    From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.

Study Arms (1)

Virtual cooking classes

EXPERIMENTAL

Two cooking classes monthly (virtual) for three months (in addition to their routine diabetes care) with the support of a diabetes educator, nutritionist, and professional chef.

Other: Virtual cooking classesOther: Routine Diabetes Care

Interventions

Two cooking classes monthly (virtual) for three months (in addition to their routine diabetes care) with the support of a diabetes educator, nutritionist, and professional chef.

Virtual cooking classes

Meet with multidisciplinary diabetes care team, including clinician, nutritionist, and diabetes educator, every 3 months to review glycemic control, general health, and medication management.

Virtual cooking classes

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • be diagnosed with T1D for at least a year
  • be 12 to 17 years of age at time of study enrollment
  • have a BMI ≥ 85th percentile
  • be able to communicate via a virtual platform if needed
  • intend to maintain status as a patient at the Children's Hospital of Pittsburgh Diabetes Center throughout the study duration.

You may not qualify if:

  • \- diagnosis of other types of diabetes (such as type 2 diabetes, MODY, cystic fibrosis related diabetes or diabetes secondary to medications).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

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

  • Ingrid Libman, MD, PhD

    UPMC Children's Hopsital of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 21, 2026

Study Start

December 4, 2023

Primary Completion

March 19, 2025

Study Completion

March 19, 2025

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified IPD that underlies results reported in publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD will be made available after publication of primary results; available indefinitely.
Access Criteria
Investigators whose proposed research has received IRB approval will be able to access de-identified IPD that underlies published results, study protocol, SAP, and ICF.

Locations