Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04152811 |
| Other study ID # |
2019H0095 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2019 |
| Est. completion date |
July 1, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
