NCT04152811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

August 21, 2019

Last Update Submit

July 17, 2021

Conditions

Keywords

nutritioncookingdiabetes self-management education

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin A1c over 4.5 months

    Change in Hemoglobin A1c over 4.5 months

    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 from baseline (0 months) to 4.5 months using SF-12 Survey

Study Arms (4)

Waitlist 1

ACTIVE COMPARATOR

usual diabetes care

Other: Usual Diabetes Care

Intervention 1

EXPERIMENTAL

6-weeks of cooking matters for diabetes classes

Behavioral: Cooking Matters for Diabetes

Waitlist 2

ACTIVE COMPARATOR

usual diabetes care

Other: Usual Diabetes Care

Intervention 2

EXPERIMENTAL

6-weeks of cooking matters for diabetes classes

Behavioral: Cooking Matters for Diabetes

Interventions

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.

Intervention 1Intervention 2

Usual Diabetes Care

Waitlist 1Waitlist 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Interest in cooking education for diabetes
  • Diagnosis of diabetes
  • Prior diabetes education
  • Most recent HbA1c ≥ 7%
  • Appropriate for a group class setting

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center - Outpatient Care East

Columbus, Ohio, 43203, United States

Location

Related Publications (2)

  • Williams A, Shrodes JC, Radabaugh JN, Braun A, Kline D, Zhao S, Brock G, Nolan TS, Garner JA, Spees CK, Joseph JJ. Outcomes of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention. J Acad Nutr Diet. 2023 Mar;123(3):477-491. doi: 10.1016/j.jand.2022.07.021. Epub 2022 Aug 10.

  • Shrodes JC, Williams A, Nolan TS, Radabaugh JN, Braun A, Kline D, Zhao S, Brock G, Garner JA, Spees CK, Joseph JJ. Feasibility of Cooking Matters for Diabetes: A 6-week Randomized, Controlled Cooking and Diabetes Self-Management Education Intervention. J Acad Nutr Diet. 2023 Mar;123(3):492-503.e5. doi: 10.1016/j.jand.2022.07.020. Epub 2022 Aug 6.

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Joshua J Joseph, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor are blinded
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Waitlist Control Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

August 21, 2019

First Posted

November 5, 2019

Study Start

July 5, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations