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Diabetes Inspired Culinary Education (DICE)

Primary Purpose

Type I Diabetes

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
DICE
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type I Diabetes

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Dave's Grocery Store and Teaching Kitchen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

% Change in Hemoglobin A1c
Blood glucose/diabetes management

Secondary Outcome Measures

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
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
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
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
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
Change in primary caregiver body mass index (kg/m2)
Assessment of weight status using calibrated stadiometer and electronic scale.
Change in child body mass index z-score
Assessment of weight status using calibrated stadiometer and electronic scale.
Change in child blood pressure z-score
Includes systolic and diastolic blood pressure z-scores
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)
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)
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)
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)
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)

Full Information

First Posted
May 17, 2019
Last Updated
December 15, 2021
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT05160142
Brief Title
Diabetes Inspired Culinary Education
Acronym
DICE
Official Title
Diabetes Inspired Culinary Education
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
November 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single group pretest-poshest study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participate in the DICE program, which entails culinary and diabetes educational programming delivered weekly for 10 consecutive weeks.
Intervention Type
Behavioral
Intervention Name(s)
DICE
Intervention Description
10-week culinary and nutrition education program for children with type I diabetes
Primary Outcome Measure Information:
Title
% Change in Hemoglobin A1c
Description
Blood glucose/diabetes management
Time Frame
Baseline/pretest, 3 months/posttest
Secondary Outcome Measure Information:
Title
Change in daily servings of fruit
Description
Daily fruit intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in daily servings of vegetables
Description
Daily vegetable intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in daily servings of whole grains
Description
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
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in daily servings of sugar-sweetened beverages
Description
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
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in daily total caloric intake
Description
Daily caloric intake assessed via 3, 24-hour dietary recalls collected electronically using the Automated Self-Assessment 24-hour (ASA-24) dietary assessment tool
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in primary caregiver body mass index (kg/m2)
Description
Assessment of weight status using calibrated stadiometer and electronic scale.
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in child body mass index z-score
Description
Assessment of weight status using calibrated stadiometer and electronic scale.
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in child blood pressure z-score
Description
Includes systolic and diastolic blood pressure z-scores
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in child food preparation attitude, self-efficacy and frequency of involvement
Description
Scale 0-132 (higher score indicates more positive attitude, higher self-efficacy, greater frequency of involvement)
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in child adherence to TIDM management regimen score
Description
Assessed via Diabetes Management Questionnaire - Scale of 14-70 (higher score indicating greater adherence to management regimen)
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in child quality of life score
Description
Assessed via Diabetes Quality of Life for Youth questionnaire - Scale of 41-205 (higher score indicating better quality of life)
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in primary caregiver self-efficacy for diabetes management score
Description
Assessed via Maternal Self-Efficacy for Diabetes Management Scale - Scale of 8-40 (higher score indicating greater self-efficacy for diabetes management)
Time Frame
Baseline/pretest, 3 months/posttest
Title
Change in primary caregiver self-efficacy for healthy meal planning and eating score
Description
Assessed via Parent Mealtime Self-Efficacy Questionnaire - Scale of 11-55 (higher score indicating greater self-efficacy for healthy meal planning and eating)
Time Frame
Baseline/pretest, 3 months/posttest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Facility Information:
Facility Name
Dave's Grocery Store and Teaching Kitchen
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diabetes Inspired Culinary Education

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