Cooking and Nutrition Education for Health Among Adults With Diabetes

This study is a multi-dimensional therapeutic lifestyle program that offers cooking and nutrition education as well as email-based health coaching to diabetic patients in an underserved Cleveland community. This is an innovative project as it is one of the first focused efforts within this community to improve diabetes control and prevent diabetes progression through cooking and nutrition as well as to systematically measure both clinical and behavioral outcomes.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Nutrition Education; Other: Cooking Lecture; Other: e-Coaching; Other: Cooking Demo; Other: Hands-on Cooking

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older
• Current State of Ohio Medicaid recipient
• Current diagnosis of diabetes, as reported in the electronic medical record
• Completed at least one diabetes education visit at STJHC
• Have daily access to a functional kitchen in home

Exclusion Criteria:

• Pregnancy or lactation or plans to be pregnant or lactate during study
• Current alcoholism or abuse of recreational drugs
• Self-reported or history of HIV or hepatitis or active tuberculosis
• Travel plans that do not permit full participation especially during the first 8 study visits
• Recent unexplained weight loss (10 pounds or more in past 3 months)
• Any diagnosis that would interfere with or prevent a change in diet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cooking Lecture; Participants in this arm will receive cooking education through lecture/PowerPoint presentation led by our executive chef. Participants will also attend nutrition education classes led by our registered dietician. Lastly, e-coaching with a certified health coach will be offered to participants with access to a personal email account.	Other: Nutrition Education; Nutrition classes will be led by a registered dietician.; Other: Cooking Lecture; Other: e-Coaching
Experimental: Cooking Demo; Participants in this arm will receive cooking education through observation of our executive chef who will explain cooking techniques and healthy food preparation practices as he cooks a healthy recipe(s) for participants to sample. Participants will also attend nutrition education classes led by our registered dietician. Lastly, e-coaching with a certified health coach will be offered to participants with access to a personal email account.	Other: Nutrition Education; Nutrition classes will be led by a registered dietician.; Other: e-Coaching; Other: Cooking Demo
Experimental: Hands-on Cooking; Participants in this arm will receive cooking education through hands on practical experience with our executive chef in a teaching kitchen. Participants will be able to sample what they prepare. Participants will also attend nutrition education classes led by our registered dietician. Lastly, e-coaching with a certified health coach will be offered to participants with access to a personal email account.	Other: Nutrition Education; Nutrition classes will be led by a registered dietician.; Other: e-Coaching; Other: Hands-on Cooking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 8 weeks	Responses to individual questions will be tracked throughout the intervention in order to evaluate basic cooking skills and knowledge of nutrition that can be used to prepare healthy meals and follow recipes.	8 weeks
Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 6 months	Responses to individual questions will be tracked throughout the intervention in order to evaluate basic cooking skills and knowledge of nutrition that can be used to prepare healthy meals and follow recipes.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height (centimeters) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
Height (centimeters) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
Weight (kilograms) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
Weight (kilograms) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
Fasting Blood Glucose (mg/dL) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
Fasting Blood Glucose (mg/dL) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
Blood Pressure - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
Blood Pressure - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
Total Cholesterol (mg/dL) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
Total Cholesterol (mg/dL) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
LDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
LDL Cholesterol (mg/dL) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
HDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
HDL Cholesterol (mg/dL) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
Triglycerides (mg/dL) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
Triglycerides (mg/dL) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
Hemoglobin A1c (%) - Change from Baseline to 8 weeks	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	8 weeks
Hemoglobin A1c (%) - Change from Baseline to 6 months	Each participant's height, weight, fasting glucose, blood pressure, blood lipids (total cholesterol, LDL, HDL, triglycerides), and HgbA1c will be abstracted from their electronic medical record at baseline, 8 weeks and 6 months (+/- 2 weeks) to record changes in values.	6 months
Dietary Fat Consumption Questionnaire - Change from Baseline to 8 weeks	Questionnaire will be given at baseline, 8 weeks and 6 months to assess nutritional consumption of fat. This Block Dietary Data Screener is a validated questionnaire with scoring to show changes over the time of the program.	8 weeks
Dietary Fat Consumption Questionnaire - Change from Baseline to 6 months	Questionnaire will be given at baseline, 8 weeks and 6 months to assess nutritional consumption of fat. This Block Dietary Data Screener is a validated questionnaire with scoring to show changes over the time of the program.	6 months
Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 8 weeks	Questionnaire will be given at baseline, 8 weeks and 6 months to assess nutritional consumption of fiber, fruits and vegetables. This Block Dietary Data Screener is a validated questionnaire generating a single composite score to show changes over the time of the program	8 weeks
Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 6 months	Questionnaire will be given at baseline, 8 weeks and 6 months to assess nutritional consumption of fiber, fruits and vegetables. This Block Dietary Data Screener is a validated questionnaire generating a single composite score to show changes over the time of the program	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: The Honor Project Trust
• Investigators: Principal Investigator: Mladen Golubic, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Nutrition; Lifestyle Medicine; Cooking
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 14-1607