NCT07084805

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Sep 2023Dec 2026

Study Start

First participant enrolled

September 1, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

July 23, 2025

Last Update Submit

December 16, 2025

Conditions

Type 1 Diabetes

Keywords

PediatricsCulinary medicineTeaching kitchenCulinary nutrition

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Blood glucose management

    9 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

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.

Behavioral: Diabetes Inspired Culinary Education (DICE) - Phase 2

Interventions

Diabetes Inspired Culinary Education (DICE) - Phase 1BEHAVIORAL

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.

Intervention
Diabetes Inspired Culinary Education (DICE) - Phase 2BEHAVIORAL

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.

Waitlist Control

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • years old
  • English speaking
  • 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.)
  • years of age or older
  • English speaking

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Clinical Trials, Phase I as TopicClinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Catherine R McManus, PhD, RDN, LD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Waitlist Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 25, 2025

Study Start

September 1, 2023

Primary Completion

October 30, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)