Phipps Conservatory's 5210 Let's Move Pittsburgh and Impact on Youth With T1D
2 other identifiers
interventional
46
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2025
CompletedFirst Submitted
Initial submission to the registry
August 7, 2026
CompletedFirst Posted
Study publicly available on registry
August 21, 2026
CompletedAugust 21, 2026
August 1, 2026
1.3 years
August 7, 2026
August 18, 2026
Conditions
Keywords
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
EXPERIMENTALTwo 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.
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.
Meet with multidisciplinary diabetes care team, including clinician, nutritionist, and diabetes educator, every 3 months to review glycemic control, general health, and medication management.
Eligibility Criteria
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
- University of Pittsburghlead
- The Pittsburgh Foundationcollaborator
Study Sites (1)
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingrid Libman, MD, PhD
UPMC Children's Hopsital of Pittsburgh
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
- 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.
De-identified IPD that underlies results reported in publication.