NCT05160142

Brief Summary

The aim of this study is to assess the feasibility and efficacy of a community-based culinary nutrition education program (Diabetes Inspired Culinary Education, DICE) on improving the diabetes management and dietary intake of 6-14 year old children with type I diabetes mellitus (TIDM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2019

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

May 17, 2019

Last Update Submit

December 15, 2021

Conditions

Type I Diabetes

Outcome Measures

Primary Outcomes (1)

  • % Change in Hemoglobin A1c

    Blood glucose/diabetes management

    Baseline/pretest, 3 months/posttest

Secondary Outcomes (13)

  • Change in daily servings of fruit

    Baseline/pretest, 3 months/posttest

  • Change in daily servings of vegetables

    Baseline/pretest, 3 months/posttest

  • Change in daily servings of whole grains

    Baseline/pretest, 3 months/posttest

  • Change in daily servings of sugar-sweetened beverages

    Baseline/pretest, 3 months/posttest

  • Change in daily total caloric intake

    Baseline/pretest, 3 months/posttest

  • +8 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Participate in the DICE program, which entails culinary and diabetes educational programming delivered weekly for 10 consecutive weeks.

Behavioral: DICE

Interventions

DICEBEHAVIORAL

10-week culinary and nutrition education program for children with type I diabetes

Intervention

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children: 6-14 years old; diagnosed with type I diabetes within the past 5 years; English speaking
  • Adults: primary caregiver of a 6-14 year old child diagnosed with type I diabetes within the past 5 years; English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dave's Grocery Store and Teaching Kitchen

Cleveland, Ohio, 44103, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single group pretest-poshest study design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2019

First Posted

December 16, 2021

Study Start

September 5, 2019

Primary Completion

November 21, 2019

Study Completion

November 21, 2019

Last Updated

January 4, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)