Culinary Education for Type 1 Diabetes

(DICE Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help families and communities better manage type 1 diabetes in young people through a special culinary program. The program, Diabetes Inspired Culinary Education (DICE), teaches cooking skills to improve health and address racial, ethnic, and socioeconomic disparities. Participants will either start the program immediately or after a delay to compare its effects. This trial suits English-speaking individuals diagnosed with type 1 diabetes for at least one year. As an unphased trial, it offers a unique opportunity to contribute to innovative educational approaches in diabetes management.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Diabetes Inspired Culinary Education (DICE) intervention is safe?

Research has shown that the Diabetes Inspired Culinary Education (DICE) program offers a new approach to help young people with type 1 diabetes manage their condition. This community program emphasizes improving diet and disease management.

In terms of safety, the DICE program does not involve medication or medical procedures. Instead, it teaches cooking skills, which is generally safe. No reports of negative effects have emerged from the program itself, suggesting it is safe for participants, as it primarily involves learning to cook to enhance health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Diabetes Inspired Culinary Education (DICE) because it offers a fresh approach to managing Type 1 Diabetes through culinary education. Unlike standard treatments that typically focus on medication and insulin management, DICE aims to empower individuals by teaching them how to prepare diabetes-friendly meals. This educational approach could enhance self-management skills and improve dietary habits, which are crucial for maintaining stable blood sugar levels. By emphasizing practical cooking skills and nutrition education, DICE has the potential to transform how people with Type 1 Diabetes manage their condition daily.

What evidence suggests that the Diabetes Inspired Culinary Education (DICE) intervention could be effective for type 1 diabetes?

Research has shown that the Diabetes Inspired Culinary Education (DICE) program can help manage type 1 diabetes in young people at risk. One study found that participants had better control of their blood sugar levels, as measured by hemoglobin A1c, after six months. Participants also improved their skills in managing their condition. In this trial, some participants will receive the DICE intervention during phase 1, focusing on teaching healthy cooking and eating habits, which are important for managing diabetes. This approach aims to reduce health disparities among various racial and economic groups. Overall, early results suggest that DICE could be a useful tool for young people in managing diabetes. ^{1 3 4 6 7}

Who Is on the Research Team?

Catherine R McManus, PhD, RDN, LD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for at-risk youth with Type 1 Diabetes, particularly from diverse racial/ethnic backgrounds and lower socioeconomic status. The aim is to address disparities in treatment outcomes.

Inclusion Criteria

English speaking

I have been diagnosed with Type 1 diabetes for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm receive the DICE culinary medicine intervention

9 months

Waitlist Control

Participants in the waitlist control arm receive usual clinical care during phase 1 and the DICE intervention during phase 2

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Inspired Culinary Education (DICE)

Trial Overview The DICE program consists of two phases of culinary medicine interventions that combine cooking with medical education to help manage diabetes more effectively.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Receive DICE intervention during phase 1 while waitlist control arm receives usual clinical care.

Group II: Waitlist Control Active Control 1 Intervention

Receive DICE intervention during phase 2 while intervention arm receives usual clinical care.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Rainbow Babies and Children's Hospital

Collaborator

Trials

9

Recruited

4,000+

Breakthrough T1D

Collaborator

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Citations

1. case.edu case.edu/news/cooking-solutions-how-one-research-study-supporting-local-kids-t1-diabetes

Cooking up solutions: How one research study is ... Funded by the American Diabetes Association, the DICE program is an evidence- and theory-based behavior change intervention, aiming to set new ...

2. researchgate.net researchgate.net/publication/352718253_907-P_Diabetes-Inspired_Culinary_Education_DICE_An_Innovative_Approach_to_Type_1_Diabetes_Management_through_Culinary_Medicine

907-P: Diabetes-Inspired Culinary Education (DICE): An ... The primary outcome includes change in haemoglobin A1c level at six months follow up. Secondary outcomes include change in self-management ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/548-P/158321/548-P-Evaluating-the-Effectiveness-of-a-Train-the

548-P: Evaluating the Effectiveness of a Train-the-Trainer ... Results: Eighteen RAs completed the baseline and post-test surveys (100%), with significant improvements from baseline to post-test across all ...

4. patlynk.com patlynk.com/trial/NCT07084805

Culinary Education for At-Risk Youth with Type 1 Diabetes The study focuses on improving the management of type 1 diabetes among at-risk youth by using a program called Diabetes Inspired Culinary Education (DICE).

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-8-2023-e1360

Culinary Education for Type 1 Diabetes (DICE Trial) ... Diabetes Inspired Culinary Education (DICE) will have tolerable side effects & efficacy for patients with Type 1 Diabetes. Learn more about the study.

6. app.trialscreen.org app.trialscreen.org/trials/diabetes-inspired-culinary-education-dice-medicine-intervention-risk-youth-trial-nct07084805

Culinary Medicine Intervention for At-Risk Youth With Type ... Diabetes Inspired Culinary Education (DICE) is an innovative family- and community-based culinary medicine intervention designed to mitigate ...

7. diabetes.org diabetes.org/sites/default/files/2023-10/2021-ADA-Research-Report-2-3-22.pdf

Better Outcomes for Life. Yet, there is a complete absence of culinary medicine interventions for youth with type 1 diabetes. Therefore, Diabetes Inspired. Culinary Education (DICE) has ...