DICE: Diabetes Inspired Culinary Education

• Sponsor: Case Western Reserve University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05160142
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type I Diabetes	Behavioral: DICE	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single group pretest-poshest study designSingle group pretest-poshest study design
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Diabetes Inspired Culinary Education
• Actual Study Start Date: Sep 5, 2019
• Actual Primary Completion Date: Nov 21, 2019
• Actual Study Completion Date: Nov 21, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. % Change in Hemoglobin A1c [Baseline/pretest, 3 months/posttest]

   Blood glucose/diabetes management

Secondary Outcome Measures

1. Change in daily servings of fruit [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

2. Change in daily servings of vegetables [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

3. Change in daily servings of whole grains [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

4. Change in daily servings of sugar-sweetened beverages [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

5. Change in daily total caloric intake [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

6. Change in primary caregiver body mass index (kg/m2) [Baseline/pretest, 3 months/posttest]

   Assessment of weight status using calibrated stadiometer and electronic scale.

7. Change in child body mass index z-score [Baseline/pretest, 3 months/posttest]

   Assessment of weight status using calibrated stadiometer and electronic scale.

8. Change in child blood pressure z-score [Baseline, 3 months, 6 months, 9 months]

   Includes systolic and diastolic blood pressure z-scores

9. Change in child food preparation attitude, self-efficacy and frequency of involvement [Baseline/pretest, 3 months/posttest]

   Scale 0-132 (higher score indicates more positive attitude, higher self-efficacy, greater frequency of involvement)

10. Change in child adherence to TIDM management regimen score [Baseline/pretest, 3 months/posttest]

    Assessed via Diabetes Management Questionnaire - Scale of 14-70 (higher score indicating greater adherence to management regimen)

11. Change in child quality of life score [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)

12. Change in primary caregiver self-efficacy for diabetes management score [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)

13. Change in primary caregiver self-efficacy for healthy meal planning and eating score [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dave's Grocery Store and Teaching Kitchen	Cleveland	Ohio	United States	44103

Sponsors and Collaborators

• Case Western Reserve University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catherine Rogers, Assistant Professor, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT05160142
• Other Study ID Numbers: STUDY20190718
• First Posted: Dec 16, 2021
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jan 4, 2022