Cooking Matters for Diabetes - A 6-Week Program for Practical Application of Diabetes Self-Management Education
July 17, 2021 updated by: Joshua Joseph, MD, Ohio State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43203
- The Ohio State University Wexner Medical Center - Outpatient Care East
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- Interest in cooking education for diabetes
- Diagnosis of diabetes
- Prior diabetes education
- Most recent HbA1c ≥ 7%
- Appropriate for a group class setting
Exclusion Criteria
- Previous participation in Cooking Matters program
- Non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Waitlist 1
usual diabetes care
|
Usual Diabetes Care
|
|
Experimental: Intervention 1
6-weeks of cooking matters for diabetes classes
|
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.
|
|
Active Comparator: Waitlist 2
usual diabetes care
|
Usual Diabetes Care
|
|
Experimental: Intervention 2
6-weeks of cooking matters for diabetes classes
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change in Hemoglobin A1c from baseline (0 months) to 4.5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change in Health Related Quality of Life over 4.5 months using SF-12 Survey
|
Change in Health Related Quality of Life from baseline (0 months) to 4.5 months using SF-12 Survey
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua J Joseph, MD, The Ohio State University Wexner Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2019
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
August 21, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (Actual)
November 5, 2019
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 17, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019H0095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.