Clinical trial NCT04152811: Cooking Matters for Diabetes - A 6-Week Program for Practical Application of Diabetes Self-Management Education
Official title: Cooking Matters for Diabetes - Practical Application of Diabetes Self-Management Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Type 1 Diabetes
Type 2 Diabetes
Keywords: nutrition
cooking
diabetes self-management education
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Academy of Nutrition and Dietetics
First posted: 2019-11-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist Control Design
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin A1c over 4.5 months
timeFrame: Change in Hemoglobin A1c from baseline (0 months) to 4.5 months
Secondary outcomes:
measure: Change in Health Related Quality of Life over 4.5 months using SF-12 Survey
timeFrame: Change in Health Related Quality of Life from baseline (0 months) to 4.5 months using SF-12 Survey
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - Outpatient Care East
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joshua J Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References: