Diabetes Inspired Culinary Education

Type I Diabetes Clinical Trial

— DICE  

Official title:

Diabetes Inspired Culinary Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05160142
• Other study ID #: STUDY20190718
• Status: Completed
• Phase: Early Phase 1
• Start date: September 5, 2019
• Est. completion date: November 21, 2019

Study information

• Verified date: December 2021
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type I Diabetes

Intervention

Behavioral:
• DICE
10-week culinary and nutrition education program for children with type I diabetes

Locations

Country	Name	City	State
United States	Dave's Grocery Store and Teaching Kitchen	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Change in Hemoglobin A1c	Blood glucose/diabetes management	Baseline/pretest, 3 months/posttest
Secondary	Change in daily servings of fruit	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
Secondary	Change in daily servings of vegetables	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
Secondary	Change in daily servings of whole grains	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
Secondary	Change in daily servings of sugar-sweetened beverages	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
Secondary	Change in daily total caloric intake	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
Secondary	Change in primary caregiver body mass index (kg/m2)	Assessment of weight status using calibrated stadiometer and electronic scale.	Baseline/pretest, 3 months/posttest
Secondary	Change in child body mass index z-score	Assessment of weight status using calibrated stadiometer and electronic scale.	Baseline/pretest, 3 months/posttest
Secondary	Change in child blood pressure z-score	Includes systolic and diastolic blood pressure z-scores	Baseline, 3 months, 6 months, 9 months
Secondary	Change in child food preparation attitude, self-efficacy and frequency of involvement	Scale 0-132 (higher score indicates more positive attitude, higher self-efficacy, greater frequency of involvement)	Baseline/pretest, 3 months/posttest
Secondary	Change in child adherence to TIDM management regimen score	Assessed via Diabetes Management Questionnaire - Scale of 14-70 (higher score indicating greater adherence to management regimen)	Baseline/pretest, 3 months/posttest
Secondary	Change in child quality of life score	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
Secondary	Change in primary caregiver self-efficacy for diabetes management score	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
Secondary	Change in primary caregiver self-efficacy for healthy meal planning and eating score	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