Type 1 DiabetesDICENCT07084805
Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes
A study testing Diabetes Inspired Culinary Education (DICE) - Phase 1 and Diabetes Inspired Culinary Education (DICE) - Phase 2 in people with Type 1 Diabetes, run by Case Western Reserve University at 1 site in United States.
Trial summary
Diabetes Inspired Culinary Education (DICE) is an innovative family- and community-based culinary medicine intervention designed to mitigate racial/ethnic and socioeconomic status disparities in the treatment and health outcomes of at-risk youth with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Diabetes Inspired Culinary Education (DICE) - Phase 1 and Diabetes Inspired Culinary Education (DICE) - Phase 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Diabetes Inspired Culinary Education (DICE): An Innovative Approach to Type 1 Diabetes Management for At-Risk Youth With Type 1 Diabetes
Diabetes Inspired Culinary Education (DICE) is an innovative family- and community-based culinary medicine intervention designed to mitigate racial/ethnic and socioeconomic status disparities in the treatment and health outcomes of at-risk youth with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Diabetes Inspired Culinary Education (DICE) - Phase 1, Diabetes Inspired Culinary Education (DICE) - Phase 2
- Keywords
- Pediatrics, Culinary medicine, Teaching kitchen, Culinary nutrition
- 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.
Diabetes Inspired Culinary Education (DICE) - Phase 1Behavioural
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.
Diabetes Inspired Culinary Education (DICE) - Phase 2Behavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive DICE intervention during phase 1 while waitlist control arm receives usual clinical care. Receives: Behavioral: Diabetes Inspired Culinary Education (DICE) - Phase 1 |
| Waitlist Control | Active comparator | Receive DICE intervention during phase 2 while intervention arm receives usual clinical care. Receives: Behavioral: Diabetes Inspired Culinary Education (DICE) - Phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Blood glucose management
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Sep 2023
- Primary completion30 Oct 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, Rainbow Babies and Children's Hospital, The Cleveland Clinic, Breakthrough T1D
- Responsible party
- Sponsor
- Investigators
- Catherine R McManus, PhD, RDN, LD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084805
- Sponsor's protocol ID
- STUDY20230091
- Acronym
- DICE
- Status last verified
- Dec 2025
- First submitted
- 23 Jul 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Inspired Culinary Education (DICE): An Innovative Approach to Type 1 Diabetes Management for At-Risk Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07084805
- Acronym / sponsor ID
- DICE / STUDY20230091
- Conditions
- Type 1 Diabetes
- Keywords
- Pediatrics, Culinary medicine, Teaching kitchen, Culinary nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association, Rainbow Babies and Children's Hospital, The Cleveland Clinic, Breakthrough T1D
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jul 2025 (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.
Diabetes Inspired Culinary Education (DICE) is an innovative family- and community-based culinary medicine intervention designed to mitigate racial/ethnic and socioeconomic status disparities in the treatment and health outcomes of at-risk youth with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Diabetes Inspired Culinary Education (DICE) - Phase 1Receive DICE intervention during phase 1 while waitlist control arm receives usual clinical care. |
| Waitlist Control | Active comparator | Behavioral: Diabetes Inspired Culinary Education (DICE) - Phase 2Receive DICE intervention during phase 2 while intervention arm receives usual clinical care. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Diabetes Inspired Culinary Education (DICE) - Phase 1The 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. | Behavioural | Intervention |
| Diabetes Inspired Culinary Education (DICE) - Phase 2The 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. | Behavioural | Waitlist Control |
Primary outcome
Hemoglobin A1c
Time frame: 9 months
Blood glucose management
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Catherine R McManus, PhD, RDN, LD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Inspired Culinary Education (DICE) - Phase 1 and Diabetes Inspired Culinary Education (DICE) - Phase 2 in people with Type 1 Diabetes, run by Case Western Reserve University 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?
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: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hemoglobin A1c (time frame: 9 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 22 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.