- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160142
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
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20190718
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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