Phipps Conservatory's 5210 Let's Move Pittsburgh and Impact on Youth With T1D
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15224
- UPMC Children's Hospital of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- diagnosis of other types of diabetes (such as type 2 diabetes, MODY, cystic fibrosis related diabetes or diabetes secondary to medications).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual cooking classes
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline clinic visit (pre cooking classes) to nearest post clinic visit after last cooking class, up to 8 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 weight (kg) 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.
|
|
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 BMI (kg/m^2) 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.
|
|
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 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.
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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.
|
Based on food logs, which include the food item and quantity for all meals consumed, 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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ingrid Libman, MD, PhD, UPMC Children's Hopsital of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23060079
- MR2022-128714 (Other Grant/Funding Number: The Pittsburgh Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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