Diabetes MellitusNCT04152811
Cooking Matters for Diabetes - A 6-Week Program for Practical Application of Diabetes Self-Management Education
A study testing Cooking Matters for Diabetes and Usual Diabetes Care in people with Diabetes Mellitus and Type 1 Diabetes, run by Ohio State University at 1 site in United States.
Trial summary
Our primary objective is to improve glycemic control (Hemoglobin A1c [HbA1c]) over 3 months in individuals with diabetes by teaching practical application of diabetes education through "Cooking Matters" compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Cooking Matters for Diabetes and Usual Diabetes Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 1 Jul 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Interest in cooking education for diabetes
- Diagnosis of diabetes
- Prior diabetes education
- Most recent HbA1c ≥ 7%
- Appropriate for a group class setting
Who cannot join
- Previous participation in Cooking Matters program
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center - Outpatient Care East
Columbus, Ohio, 43203
About this study
Official title: Cooking Matters for Diabetes - Practical Application of Diabetes Self-Management Education
Our primary objective is to improve glycemic control (Hemoglobin A1c [HbA1c]) over 3 months in individuals with diabetes by teaching practical application of diabetes education through "Cooking Matters" compared to usual care.
Our secondary objective is to improve health related quality of life, adherence to diabetes self-management behaviors (physical activity, diet, glucose monitoring, and medication adherence) over 3-months compared to usual care.
We hypothesize that participants in the cooking matters intervention will have significant improvement in glycemic control (HbA1c), HRQOL, and adherence to diabetes self- management compared to usual care. Our study is significant as it examines a novel approach to improving diabetes care and addressing glycemic control in diabetes.
Read the detailed description
We will enroll 60 participants with diabetes and HbA1c ≥ 7% in a Cooking Matters (CM) program using a waitlist control design with 30 participants in the intervention group and 30 participants in the waitlist control group, separated into two arms.Participants will be stratified by sex and randomized using a random number generator program to either the intervention or wait list control group. Each CM course is made up of 6, 2-hour, weekly classes with 15 participants. The curricula is based on the Dietary Guidelines for Americans, MyPlate (the current nutrition guide published by the USDA Center for Nutrition Policy and Promotion, a food circle depicting a place setting with a plate and glass divided into five food groups), the American Diabetes Association Standards of Medical Care in Diabetes 2017 and Medical Nutrition Therapy Evidence Based Guide for Practice/Nutrition Protocol as the foundation for basic nutrition guidelines, then builds upon these ideas using the collective groups' needs and interest to provide interactive lessons to teach cooking, food safety and food resource management with emphasis placed on blood sugar management. Five of the 6 classes will include hands-on cooking instruction and nutrition instruction; one of the 6 classes will be a grocery store tour held in a grocery store of the groups' choosing. This class will provide nutrition instruction with the focus on meal planning for optimal glucose control under the constraints of a budget. Each class will be interactive and provides participants opportunities to demonstrate their understanding of the lesson. Participants are encouraged to ask questions, offer solutions and share their experiences. At the end of each class, when food preparation is highlighted, the class and instructors will gather to sample all recipes and have open discussion. Each participant will take home a bag of groceries with the ingredients to replicate the recipes made in class. At the beginning of each class, participants are encouraged to share with the group how they used of the previous week's groceries and reflect on cooking at home. We will administer validated surveys measuring health-related quality of life, diabetes self-management behaviors, and dietary patterns and perform point of care HbA1c assessment of both groups (intervention and waitlist control) when intervention 1 begins the program in week 1. We will then proceed with the CM intervention with intervention 1 in weeks 1 thru 6 and the post test will be administered to the intervention group at the end of the intervention, 3, 6 and 12 months post intervention. In week 18-23, we will administer CM to the original waitlist control group and they will follow the same protocol as intervention 1. The second arm of the study will follow the same design, beginning in week 12 of the study.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Cooking Matters for Diabetes, Usual Diabetes Care
- Keywords
- nutrition, cooking, diabetes self-management education
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking Matters for DiabetesBehavioural
Each Cooking Matters course is made up of 6, 2-hour, weekly classes with 15 participants. The curricula is based on the Dietary Guidelines for Americans, MyPlate, the American Diabetes Association Standards of Medical Care in Diabetes 2017 and Medical Nutrition Therapy Evidence Based Guide for Practice/Nutrition Protocol as the foundation for basic nutrition guidelines, then builds upon these ideas using the collective groups' needs and interest to provide interactive lessons to teach cooking, food safety and food resource management with emphasis placed on blood sugar management.
Usual Diabetes CareOther
Usual Diabetes Care
| Study group | Role | What they receive |
|---|---|---|
| Waitlist 1 | Active comparator | usual diabetes care Receives: Other: Usual Diabetes Care |
| Intervention 1 | Experimental | 6-weeks of cooking matters for diabetes classes Receives: Behavioral: Cooking Matters for Diabetes |
| Waitlist 2 | Active comparator | usual diabetes care Receives: Other: Usual Diabetes Care |
| Intervention 2 | Experimental | 6-weeks of cooking matters for diabetes classes Receives: Behavioral: Cooking Matters for Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c over 4.5 months
Change in Hemoglobin A1c over 4.5 months
Measured: Change in Hemoglobin A1c from baseline (0 months) to 4.5 months
Secondary outcomes (1)
Change in Health Related Quality of Life over 4.5 months using SF-12 Survey
Change in Health Related Quality of Life over 4.5 months using SF-12 Survey
Measured: Change in Health Related Quality of Life from baseline (0 months) to 4.5 months using SF-12 Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start5 Jul 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist Control Design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Principal investigator, Joshua Joseph, MD, Ohio State University
- Investigators
- Joshua J Joseph, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152811
- Sponsor's protocol ID
- 2019H0095
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams A, Shrodes JC, Radabaugh JN, Braun A, Kline D, Zhao S, Brock G, Nolan TS, Garner JA, Spees CK, Joseph JJ. Outcomes of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention. J Acad Nutr Diet. 2023 Mar;123(3):477-491. doi: 10.1016/j.jand.2022.07.021. Epub 2022 Aug 10.
PubMed 35961614Shrodes JC, Williams A, Nolan TS, Radabaugh JN, Braun A, Kline D, Zhao S, Brock G, Garner JA, Spees CK, Joseph JJ. Feasibility of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention. J Acad Nutr Diet. 2023 Mar;123(3):492-503.e5. doi: 10.1016/j.jand.2022.07.020. Epub 2022 Aug 6.
PubMed 35944873
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooking Matters for Diabetes - Practical Application of Diabetes Self-Management Education
- ClinicalTrials.gov ID
- NCT04152811
- Acronym / sponsor ID
- 2019H0095
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Type 2 Diabetes
- Keywords
- nutrition, cooking, diabetes self-management education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 5 Nov 2019 (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.
Our primary objective is to improve glycemic control (Hemoglobin A1c [HbA1c]) over 3 months in individuals with diabetes by teaching practical application of diabetes education through "Cooking Matters" compared to usual care.
Our secondary objective is to improve health related quality of life, adherence to diabetes self-management behaviors (physical activity, diet, glucose monitoring, and medication adherence) over 3-months compared to usual care.
We hypothesize that participants in the cooking matters intervention will have significant improvement in glycemic control (HbA1c), HRQOL, and adherence to diabetes self- management compared to usual care. Our study is significant as it examines a novel approach to improving diabetes care and addressing glycemic control in diabetes.
Detailed description
We will enroll 60 participants with diabetes and HbA1c ≥ 7% in a Cooking Matters (CM) program using a waitlist control design with 30 participants in the intervention group and 30 participants in the waitlist control group, separated into two arms.Participants will be stratified by sex and randomized using a random number generator program to either the intervention or wait list control group. Each CM course is made up of 6, 2-hour, weekly classes with 15 participants. The curricula is based on the Dietary Guidelines for Americans, MyPlate (the current nutrition guide published by the USDA Center for Nutrition Policy and Promotion, a food circle depicting a place setting with a plate and glass divided into five food groups), the American Diabetes Association Standards of Medical Care in Diabetes 2017 and Medical Nutrition Therapy Evidence Based Guide for Practice/Nutrition Protocol as the foundation for basic nutrition guidelines, then builds upon these ideas using the collective groups' needs and interest to provide interactive lessons to teach cooking, food safety and food resource management with emphasis placed on blood sugar management. Five of the 6 classes will include hands-on cooking instruction and nutrition instruction; one of the 6 classes will be a grocery store tour held in a grocery store of the groups' choosing. This class will provide nutrition instruction with the focus on meal planning for optimal glucose control under the constraints of a budget. Each class will be interactive and provides participants opportunities to demonstrate their understanding of the lesson. Participants are encouraged to ask questions, offer solutions and share their experiences. At the end of each class, when food preparation is highlighted, the class and instructors will gather to sample all recipes and have open discussion. Each participant will take home a bag of groceries with the ingredients to replicate the recipes made in class. At the beginning of each class, participants are encouraged to share with the group how they used of the previous week's groceries and reflect on cooking at home. We will administer validated surveys measuring health-related quality of life, diabetes self-management behaviors, and dietary patterns and perform point of care HbA1c assessment of both groups (intervention and waitlist control) when intervention 1 begins the program in week 1. We will then proceed with the CM intervention with intervention 1 in weeks 1 thru 6 and the post test will be administered to the intervention group at the end of the intervention, 3, 6 and 12 months post intervention. In week 18-23, we will administer CM to the original waitlist control group and they will follow the same protocol as intervention 1. The second arm of the study will follow the same design, beginning in week 12 of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Waitlist Control Design
| Arm | Type | Receives |
|---|---|---|
| Waitlist 1 | Active comparator | Other: Usual Diabetes Careusual diabetes care |
| Intervention 1 | Experimental | Behavioral: Cooking Matters for Diabetes6-weeks of cooking matters for diabetes classes |
| Waitlist 2 | Active comparator | Other: Usual Diabetes Careusual diabetes care |
| Intervention 2 | Experimental | Behavioral: Cooking Matters for Diabetes6-weeks of cooking matters for diabetes classes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Interest in cooking education for diabetes
- Diagnosis of diabetes
- Prior diabetes education
- Most recent HbA1c ≥ 7%
- Appropriate for a group class setting
Key exclusion criteria (2 listed)
- Previous participation in Cooking Matters program
- Non-English speaking
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 |
|---|---|---|
| Cooking Matters for DiabetesEach Cooking Matters course is made up of 6, 2-hour, weekly classes with 15 participants. The curricula is based on the Dietary Guidelines for Americans, MyPlate, the American Diabetes Association Standards of Medical Care in Diabetes 2017 and Medical Nutrition Therapy Evidence Based Guide for Practice/Nutrition Protocol as the foundation for basic nutrition guidelines, then builds upon these ideas using the collective groups' needs and interest to provide interactive lessons to teach cooking, food safety and food resource management with emphasis placed on blood sugar management. | Behavioural | Intervention 1, Intervention 2 |
| Usual Diabetes CareUsual Diabetes Care | Other | Waitlist 1, Waitlist 2 |
Primary outcome
Change in Hemoglobin A1c over 4.5 months
Time frame: Change in Hemoglobin A1c from baseline (0 months) to 4.5 months
Change in Hemoglobin A1c over 4.5 months
1 secondary outcome
Change in Health Related Quality of Life over 4.5 months using SF-12 Survey
Time frame: Change in Health Related Quality of Life from baseline (0 months) to 4.5 months using SF-12 Survey
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 20 Jul 2021.
- Derived from this study: PubMed 35961614Williams A, Shrodes JC, Radabaugh JN, Braun A, Kline D, Zhao S, Brock G, Nolan TS, Garner JA, Spees CK, Joseph JJ. Outcomes of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention. J Acad Nutr Diet. 2023 Mar;123(3):477-491. doi: 10.1016/j.jand.2022.07.021. Epub 2022 Aug 10.
- Derived from this study: PubMed 35944873Shrodes JC, Williams A, Nolan TS, Radabaugh JN, Braun A, Kline D, Zhao S, Brock G, Garner JA, Spees CK, Joseph JJ. Feasibility of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention. J Acad Nutr Diet. 2023 Mar;123(3):492-503.e5. doi: 10.1016/j.jand.2022.07.020. Epub 2022 Aug 6.
- 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.
Joshua J Joseph, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking Matters for Diabetes and Usual Diabetes Care in people with Diabetes Mellitus and Type 1 Diabetes, run by Ohio State 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 5 inclusion and 2 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 20 Jul 2021. 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.
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 over 4.5 months (time frame: Change in Hemoglobin A1c from baseline (0 months) to 4.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04152811, which also lists 2 linked publications.
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 20 Jul 2021.