Type I DiabetesEarly Phase 1DICENCT05160142
Diabetes Inspired Culinary Education
A Early Phase 1 study testing DICE in people with Type I Diabetes, run by Case Western Reserve University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- DICE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 21 Nov 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Dave's Grocery Store and Teaching Kitchen
Cleveland, Ohio, 44103
About this study
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).
- Conditions
- Type I Diabetes
- Being tested
- DICE
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DICEBehavioural
10-week culinary and nutrition education program for children with type I diabetes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participate in the DICE program, which entails culinary and diabetes educational programming delivered weekly for 10 consecutive weeks. Receives: Behavioral: DICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change in Hemoglobin A1c
Blood glucose/diabetes management
Measured: Baseline/pretest, 3 months/posttest
Secondary outcomes (13)
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
Measured: Baseline/pretest, 3 months/posttest
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
Measured: Baseline/pretest, 3 months/posttest
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
Measured: Baseline/pretest, 3 months/posttest
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
Measured: Baseline/pretest, 3 months/posttest
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
Measured: Baseline/pretest, 3 months/posttest
Change in primary caregiver body mass index (kg/m2)
Assessment of weight status using calibrated stadiometer and electronic scale.
Measured: Baseline/pretest, 3 months/posttest
Change in child body mass index z-score
Assessment of weight status using calibrated stadiometer and electronic scale.
Measured: Baseline/pretest, 3 months/posttest
Change in child blood pressure z-score
Includes systolic and diastolic blood pressure z-scores
Measured: Baseline, 3 months, 6 months, 9 months
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)
Measured: Baseline/pretest, 3 months/posttest
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)
Measured: Baseline/pretest, 3 months/posttest
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)
Measured: Baseline/pretest, 3 months/posttest
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)
Measured: Baseline/pretest, 3 months/posttest
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)
Measured: Baseline/pretest, 3 months/posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start5 Sep 2019
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pretest-poshest study design
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Rogers, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160142
- Sponsor's protocol ID
- STUDY20190718
- Acronym
- DICE
- Status last verified
- Dec 2021
- First submitted
- 17 May 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Inspired Culinary Education
- ClinicalTrials.gov ID
- NCT05160142
- Acronym / sponsor ID
- DICE / STUDY20190718
- Conditions
- Type I Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pretest-poshest study design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: DICEParticipate in the DICE program, which entails culinary and diabetes educational programming delivered weekly for 10 consecutive weeks. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DICE10-week culinary and nutrition education program for children with type I diabetes | Behavioural | Intervention |
Primary outcome
% Change in Hemoglobin A1c
Time frame: Baseline/pretest, 3 months/posttest
Blood glucose/diabetes management
13 secondary outcomes
Change in daily servings of fruit
Time frame: Baseline/pretest, 3 months/posttest
Change in daily servings of vegetables
Time frame: Baseline/pretest, 3 months/posttest
Change in daily servings of whole grains
Time frame: Baseline/pretest, 3 months/posttest
Change in daily servings of sugar-sweetened beverages
Time frame: Baseline/pretest, 3 months/posttest
Change in daily total caloric intake
Time frame: Baseline/pretest, 3 months/posttest
Change in primary caregiver body mass index (kg/m2)
Time frame: Baseline/pretest, 3 months/posttest
Change in child body mass index z-score
Time frame: Baseline/pretest, 3 months/posttest
Change in child blood pressure z-score
Time frame: 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
Change in child adherence to TIDM management regimen score
Time frame: Baseline/pretest, 3 months/posttest
Change in child quality of life score
Time frame: Baseline/pretest, 3 months/posttest
Change in primary caregiver self-efficacy for diabetes management score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DICE in people with Type I Diabetes, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Change in Hemoglobin A1c (time frame: Baseline/pretest, 3 months/posttest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.