Type 1 Diabetes MellitusNCT07780487
Phipps Conservatory's 5210 Let's Move Pittsburgh and Impact on Youth With T1D
A study testing Virtual cooking classes and Routine Diabetes Care in people with Type 1 Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Virtual cooking classes and Routine Diabetes Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 19 Mar 2025
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- diagnosis of other types of diabetes (such as type 2 diabetes, MODY, cystic fibrosis related diabetes or diabetes secondary to medications).
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
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.
Read more
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.
Read the detailed description
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. The program included 25 adolescents (11-16 years of age) with T1D, 20% Black or biracial and ~30% with socio-economic disadvantage.
This proposal's objective is to start to evaluate the potential medical benefits as the investigators expand this program. Youth with T1D (12 to 17 years of age) who are also overweight (body mass index (BMI) > 85th percentile)will be invited to participate and enroll.
The program will consist of two classes monthly (virtual) for three months (in addition to their routine diabetes care). A total of 60 children will be enrolled (20 per cohort) and "matched" to an equal number of youth from the pediatric diabetes clinic at UPMC CHP who will not participate in the program and will serve as controls. Pre- and post-program assessments will be conducted to include metrics of glycemic control (hemoglobin A1c (HbA1c) and continuous glucose monitor (CGM) parameters), clinical parameters such as weight and BMI, measurements of lipids, questionnaires on dietary knowledge, and quantity and quality of food consumption based on food logs.
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 postintervention assessments.
The aim of this study is to determine whether participation in an innovative community-based nutritional education program in addition to routine care (intervention group) improves glycemic control as assessed by change in HbA1c (primary outcome) as well as change in weight, BMI, and diabetes-related dietary knowledge (secondary outcomes) in youth 12 to 17 years old with T1D.
The investigators hypothesize that those participating in this program will have decrease in HbA1c and decrease or maintenance of BMI following the intervention. Furthermore, these changes will not be seen in the control group. Those in the intervention group will also experience increased dietary knowledge/food choices after undergoing the intervention when comparing pre- and post-assessments. In addition, for those who use CGMS, (Continuous Glucose Monitoring Systems), the investigators will also evaluate the impact of the intervention on CGM parameters.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Virtual cooking classes, Routine Diabetes Care
- Keywords
- Type 1 Diabetes, Nutrition, Cooking classes, Virtual intervention, Adolescents, Diabetes education
- 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.
Virtual cooking classesOther
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.
Routine Diabetes CareOther
Meet with multidisciplinary diabetes care team, including clinician, nutritionist, and diabetes educator, every 3 months to review glycemic control, general health, and medication management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual cooking classes; Other: Routine Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Metric of glycemic control: change in HbA1c from pre- to post- intervention.
Measured: 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
Change in weight (kg) from pre- to post- intervention.
Measured: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
Change in BMI
Change in BMI (kg/m^2) from pre- to post- intervention.
Measured: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
Change in dietary knowledge
Change in dietary knowledge assessed using the Type 1 Diabetes Nutrition Knowledge Survey, validated questionnaire as well as quantity and quality of food consumption based on food logs from pre- to post- intervention. This 23-item measure assesses diabetes \& general nutritional knowledge, scored based on the number of correct items with a range from 0-100%., with a higher percentage indicating more correct answers.
Measured: 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
Based on food logs, which include the food item and quantity for all meals consumed, from pre- to post- intervention.
Measured: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start4 Dec 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Pittsburgh Foundation
- Responsible party
- Principal investigator, Ingrid Libman, University of Pittsburgh
- Investigators
- Ingrid Libman, MD, PhD, Principal investigator, UPMC Children's Hopsital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780487
- Sponsor's protocol ID
- STUDY23060079
- Other IDs
- MR2022-128714
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlies results reported in publication.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phipps Conservatory's 5210 Let's Move Pittsburgh and Impact on Youth With T1D
- ClinicalTrials.gov ID
- NCT07780487
- Acronym / sponsor ID
- STUDY23060079
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes, Nutrition, Cooking classes, Virtual intervention, Adolescents, Diabetes education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Pittsburgh Foundation
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 21 Aug 2026 (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.
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.
Detailed description
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. The program included 25 adolescents (11-16 years of age) with T1D, 20% Black or biracial and ~30% with socio-economic disadvantage.
This proposal's objective is to start to evaluate the potential medical benefits as the investigators expand this program. Youth with T1D (12 to 17 years of age) who are also overweight (body mass index (BMI) > 85th percentile)will be invited to participate and enroll.
The program will consist of two classes monthly (virtual) for three months (in addition to their routine diabetes care). A total of 60 children will be enrolled (20 per cohort) and "matched" to an equal number of youth from the pediatric diabetes clinic at UPMC CHP who will not participate in the program and will serve as controls. Pre- and post-program assessments will be conducted to include metrics of glycemic control (hemoglobin A1c (HbA1c) and continuous glucose monitor (CGM) parameters), clinical parameters such as weight and BMI, measurements of lipids, questionnaires on dietary knowledge, and quantity and quality of food consumption based on food logs.
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 postintervention assessments.
The aim of this study is to determine whether participation in an innovative community-based nutritional education program in addition to routine care (intervention group) improves glycemic control as assessed by change in HbA1c (primary outcome) as well as change in weight, BMI, and diabetes-related dietary knowledge (secondary outcomes) in youth 12 to 17 years old with T1D.
The investigators hypothesize that those participating in this program will have decrease in HbA1c and decrease or maintenance of BMI following the intervention. Furthermore, these changes will not be seen in the control group. Those in the intervention group will also experience increased dietary knowledge/food choices after undergoing the intervention when comparing pre- and post-assessments. In addition, for those who use CGMS, (Continuous Glucose Monitoring Systems), the investigators will also evaluate the impact of the intervention on CGM parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual cooking classes | Experimental | Other: Virtual cooking classes, Other: Routine Diabetes CareTwo 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- diagnosis of other types of diabetes (such as type 2 diabetes, MODY, cystic fibrosis related diabetes or diabetes secondary to medications).
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 |
|---|---|---|
| Virtual cooking classesTwo 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 classes |
| Routine Diabetes CareMeet with multidisciplinary diabetes care team, including clinician, nutritionist, and diabetes educator, every 3 months to review glycemic control, general health, and medication management. | Other | Virtual cooking classes |
Primary outcome
Change in Hemoglobin A1c
Time frame: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
Metric of glycemic control: change in HbA1c from pre- to post- intervention.
4 secondary outcomes
Change in Weight
Time frame: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
Change in BMI
Time frame: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
Change in dietary knowledge
Time frame: 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
Time frame: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD that underlies results reported in publication.
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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.
Ingrid Libman, MD, PhD principal investigator
UPMC Children's Hopsital of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual cooking classes and Routine Diabetes Care in people with Type 1 Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 21 Aug 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.). 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 21 Aug 2026.