Diabetes Inspired Culinary Education (DICE)

December 15, 2021 updated by: Catherine Rogers, Case Western Reserve University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44103
        • Dave's Grocery Store and Teaching Kitchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participate in the DICE program, which entails culinary and diabetes educational programming delivered weekly for 10 consecutive weeks.
10-week culinary and nutrition education program for children with type I diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Change in Hemoglobin A1c
Time Frame: Baseline/pretest, 3 months/posttest
Blood glucose/diabetes management
Baseline/pretest, 3 months/posttest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in daily servings of fruit
Time Frame: Baseline/pretest, 3 months/posttest
Daily fruit intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Baseline/pretest, 3 months/posttest
Change in daily servings of vegetables
Time Frame: Baseline/pretest, 3 months/posttest
Daily vegetable intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Baseline/pretest, 3 months/posttest
Change in daily servings of whole grains
Time Frame: Baseline/pretest, 3 months/posttest
Daily whole grain intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Baseline/pretest, 3 months/posttest
Change in daily servings of sugar-sweetened beverages
Time Frame: Baseline/pretest, 3 months/posttest
Daily sugar-sweetened beverage intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Baseline/pretest, 3 months/posttest
Change in daily total caloric intake
Time Frame: Baseline/pretest, 3 months/posttest
Daily caloric intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Baseline/pretest, 3 months/posttest
Change in primary caregiver body mass index (kg/m2)
Time Frame: Baseline/pretest, 3 months/posttest
Assessment of weight status using calibrated stadiometer and electronic scale.
Baseline/pretest, 3 months/posttest
Change in child body mass index z-score
Time Frame: Baseline/pretest, 3 months/posttest
Assessment of weight status using calibrated stadiometer and electronic scale.
Baseline/pretest, 3 months/posttest
Change in child blood pressure z-score
Time Frame: Baseline, 3 months, 6 months, 9 months
Includes systolic and diastolic blood pressure z-scores
Baseline, 3 months, 6 months, 9 months
Change in child food preparation attitude, self-efficacy and frequency of involvement
Time Frame: Baseline/pretest, 3 months/posttest
Scale 0-132 (higher score indicates more positive attitude, higher self-efficacy, greater frequency of involvement)
Baseline/pretest, 3 months/posttest
Change in child adherence to TIDM management regimen score
Time Frame: Baseline/pretest, 3 months/posttest
Assessed via Diabetes Management Questionnaire - Scale of 14-70 (higher score indicating greater adherence to management regimen)
Baseline/pretest, 3 months/posttest
Change in child quality of life score
Time Frame: Baseline/pretest, 3 months/posttest
Assessed via Diabetes Quality of Life for Youth questionnaire - Scale of 41-205 (higher score indicating better quality of life)
Baseline/pretest, 3 months/posttest
Change in primary caregiver self-efficacy for diabetes management score
Time Frame: Baseline/pretest, 3 months/posttest
Assessed via Maternal Self-Efficacy for Diabetes Management Scale - Scale of 8-40 (higher score indicating greater self-efficacy for diabetes management)
Baseline/pretest, 3 months/posttest
Change in primary caregiver self-efficacy for healthy meal planning and eating score
Time Frame: Baseline/pretest, 3 months/posttest
Assessed via Parent Mealtime Self-Efficacy Questionnaire - Scale of 11-55 (higher score indicating greater self-efficacy for healthy meal planning and eating)
Baseline/pretest, 3 months/posttest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2019

Primary Completion (Actual)

November 21, 2019

Study Completion (Actual)

November 21, 2019

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

December 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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