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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Waitlist 1
usual diabetes care
Other: Usual Diabetes Care
Usual Diabetes Care
Experimental: Intervention 1
6-weeks of cooking matters for diabetes classes
Behavioral: Cooking 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.
Active Comparator: Waitlist 2
usual diabetes care
Other: Usual Diabetes Care
Usual Diabetes Care
Experimental: Intervention 2
6-weeks of cooking matters for diabetes classes
Behavioral: Cooking 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academy of Nutrition and Dietetics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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