Suspended
DICE

Culinary Education for At-Risk Youth with Type 1 Diabetes

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What is being tested

Diabetes Inspired Culinary Education (DICE) - Phase 1

+ Diabetes Inspired Culinary Education (DICE) - Phase 2
Behavioral
Who is being recruted

Autoimmune Diseases
+5

+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
From 8 to 14 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2023
See protocol details

Summary

Principal SponsorCase Western Reserve University
Last updated: December 23, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2023Actual date on which the first participant was enrolled.

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). This program is specially designed to help young people and their families learn about healthy cooking and eating habits. It aims to address and reduce the differences in diabetes care and health outcomes that can be seen among different racial, ethnic, and socioeconomic groups. By teaching culinary skills, the program hopes to provide these young people with better tools and knowledge to manage their condition effectively. Participants in this study will engage in family and community-based culinary education sessions. Through these sessions, they will learn how to prepare meals that support their diabetes management. The study will measure how well this program helps improve the participants' ability to manage their diabetes, although specific outcomes being measured are not detailed. The goal is to see if this approach can lead to better health results for these youths by empowering them with practical skills and knowledge.

Official TitleDiabetes Inspired Culinary Education (DICE): An Innovative Approach to Type 1 Diabetes Management for At-Risk Youth With Type 1 Diabetes 
NCT07084805
Principal SponsorCase Western Reserve University
Last updated: December 23, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
32 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 8 to 14 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Autoimmune Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Endocrine System Diseases
Immune System Diseases
Metabolic Diseases
Nutritional and Metabolic Diseases
Glucose Metabolism Disorders
Criteria

Child Inclusion Criteria: * Type 1 diabetes diagnosis for at least 12 months by study completion * Poor glycemic control (1 HbA1c test results ≥ 7.0 % over the past 12 months or blood sugar levels \> 155 mg/dL 3 or more times a week * 8-14 years old * English speaking Caregiver Inclusion Criteria: * Must be the primary caregiver of the participating child, (i.e., the individual who takes the lead role in helping the child manage their type 1 diabetes (e.g., monitoring blood sugars, planning meals/snacks, carbohydrate counting, etc.) * 18 years of age or older * English speaking Child Exclusion Criteria: * Not aged 8-14 * No demonstration of poor glycemic control * Diagnosis of type 1 diabetes for less than 1 year by program completion * Not English speaking Caregiver Exclusion Criteria: * Not the child's primary caregiver, (i.e., the individual who takes the lead role in helping the child manage their type 1 diabetes) * Less than 18 years of age * Not English speaking

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Receive DICE intervention during phase 1 while waitlist control arm receives usual clinical care.

The DICE intervention is a 10-lesson family-and community-based culinary nutrition and diabetes education program. Intervention Mapping, a protocol for developing theory- and evidence-based health promotion programs, was utilized to develop the DICE intervention. Rooted in the Social Cognitive Theory, the DICE intervention targets key personal, behavioral, and environmental constructs as mechanistic pathways for eliciting change in the consequential health outcomes of poor glycemic control in children and adolescents with type 1 diabetes.
Group II
Active Comparator
Receive DICE intervention during phase 2 while intervention arm receives usual clinical care.

The DICE intervention is a 10-lesson family-and community-based culinary nutrition and diabetes education program. Intervention Mapping, a protocol for developing theory- and evidence-based health promotion programs, was utilized to develop the DICE intervention. Rooted in the Social Cognitive Theory, the DICE intervention targets key personal, behavioral, and environmental constructs as mechanistic pathways for eliciting change in the consequential health outcomes of poor glycemic control in children and adolescents with type 1 diabetes.
Study Objectives
Primary Objectives

Blood glucose management

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Case Western Reserve UniversityCleveland, United StatesSee the location
SuspendedOne Study Center
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