Cooking and Nutrition Education for Health Among Adults With Diabetes

Diabetes Clinical Trial

Official title:

Cooking and Nutrition Education for Health Among Adults With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548299
• Other study ID #: 14-1607
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Nutrition Education
Nutrition classes will be led by a registered dietician.
• Cooking Lecture

• Cooking Demo

• Hands-on Cooking

• e-Coaching

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	The Honor Project Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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