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

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ClinicalTrials.gov Identifier: NCT04152811
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Academy of Nutrition and Dietetics
Information provided by (Responsible Party):
Joshua Joseph, MD, Ohio State University

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Diabetes Type 2 Diabetes Behavioral: Cooking Matters for Diabetes Other: Usual Diabetes Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Waitlist Control Design
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes Assessor are blinded
Primary Purpose: Supportive Care
Official Title: Cooking Matters for Diabetes - Practical Application of Diabetes Self-Management Education
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152811


Contacts
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Contact: Jennifer Shrodes, RD 614-688-6255 jennifer.shrodes@osumc.edu
Contact: Jessica Radabaugh, MS 614-688-6255 radabaugh.22@osu.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center - Outpatient Care East Recruiting
Columbus, Ohio, United States, 43203
Contact: Jennifer Shrodes, RD    614-688-6255    jennifer.shrodes@osumc.edu   
Contact: Jessica Radabaugh, MS    614-688-6255    radabaugh.22@osu.edu   
Sponsors and Collaborators
Ohio State University
Academy of Nutrition and Dietetics
Investigators
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Principal Investigator: Joshua J Joseph, MD The Ohio State University Wexner Medical Center

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Responsible Party: Joshua Joseph, MD, Assistant Professor of Medicine, Ohio State University
ClinicalTrials.gov Identifier: NCT04152811     History of Changes
Other Study ID Numbers: 2019H0095
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua Joseph, MD, Ohio State University:
nutrition
cooking
diabetes self-management education
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases