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Completed

NCT Number: NCT05160142

Diabetes Inspired Culinary Education

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).

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Key information

Conditions

Type I Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dave's Grocery Store and Teaching Kitchen

Cleveland, Ohio, 44103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

DICE

Behavioral

10-week culinary and nutrition education program for children with type I diabetes

Primary outcomes

  1. % Change in Hemoglobin A1c

    Time frame: Baseline/pretest, 3 months/posttest

    Blood glucose/diabetes management

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. Change in child blood pressure z-score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    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)

  12. 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)

  13. 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)

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Acronym: DICE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2021
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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