Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes

NCT ID: NCT07084805

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Keywords

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Pediatrics Culinary medicine Teaching kitchen Culinary nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Waitlist Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Diabetes Inspired Culinary Education (DICE) - Phase 1

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Diabetes Inspired Culinary Education (DICE) - Phase 2

Intervention Type BEHAVIORAL

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.

Interventions

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Diabetes Inspired Culinary Education (DICE) - Phase 1

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 Type BEHAVIORAL

Diabetes Inspired Culinary Education (DICE) - Phase 2

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 Type BEHAVIORAL

Eligibility Criteria

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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


* 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

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


* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Diabetes Association

OTHER

Sponsor Role collaborator

Rainbow Babies and Children's Hospital

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Breakthrough T1D

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine R McManus, PhD, RDN, LD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY20230091

Identifier Type: -

Identifier Source: org_study_id