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CompletedNCT04152811Updated Jul 20, 2021

Cooking Matters for Diabetes - A 6-Week Program for Practical Application of Diabetes Self-Management Education

An interventional study of Cooking Matters for Diabetes and Usual Diabetes Care in Diabetes Mellitus, Type 1 Diabetes and Type 2 Diabetes, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Ohio State University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Diabetes Mellitus
  • Type 1 Diabetes
  • Type 2 Diabetes

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Keywords

  • nutrition
  • cooking
  • diabetes self-management education
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria

  • Previous participation in Cooking Matters program
  • Non-English speaking
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Waitlist 1

    usual diabetes care

    Other: Usual Diabetes Care

  • Experimental
    Intervention 1

    6-weeks of cooking matters for diabetes classes

    Behavioral: Cooking Matters for Diabetes

  • Active comparator
    Waitlist 2

    usual diabetes care

    Other: Usual Diabetes Care

  • Experimental
    Intervention 2

    6-weeks of cooking matters for diabetes classes

    Behavioral: Cooking Matters for Diabetes

Interventions

  • BehavioralCooking Matters for Diabetes

    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.

  • OtherUsual Diabetes Care

    Usual Diabetes Care

06

What researchers measure

Primary outcomes

  1. Change in Hemoglobin A1c over 4.5 months

    Change in Hemoglobin A1c over 4.5 months

    Time frame: 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

    Time frame: Change in Health Related Quality of Life from baseline (0 months) to 4.5 months using SF-12 Survey

07

Study locations

1 site
  • The Ohio State University Wexner Medical Center - Outpatient Care East
    Columbus, Ohio 43203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04152811
Lead sponsor
Ohio State University
Collaborators
Academy of Nutrition and Dietetics
Responsible party
Joshua Joseph, MD (Assistant Professor of Medicine, Ohio State University) — Principal investigator
First posted
Nov 5, 2019
Start date
Jul 5, 2019
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021
Last update
Jul 20, 2021

Study contacts

Joshua J Joseph, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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