Diabetes
Conditions
Keywords
Diabetes, Cooking, Nutrition, Lifestyle Medicine
Brief 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.
Interventions
OTHERNutrition Education
Nutrition classes will be led by a registered dietician.
OTHERCooking Lecture
OTHERCooking Demo
OTHERHands-on Cooking
OTHERe-Coaching
Sponsors
The Honor Project Trust
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 8 weeks | 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. |
| Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight (kilograms) - Change from Baseline to 8 weeks | 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. |
| Weight (kilograms) - Change from Baseline to 6 months | 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. |
| Fasting Blood Glucose (mg/dL) - Change from Baseline to 8 weeks | 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. |
| Fasting Blood Glucose (mg/dL) - Change from Baseline to 6 months | 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. |
| Blood Pressure - Change from Baseline to 8 weeks | 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. |
| Blood Pressure - Change from Baseline to 6 months | 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. |
| Total Cholesterol (mg/dL) - Change from Baseline to 8 weeks | 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. |
| Total Cholesterol (mg/dL) - Change from Baseline to 6 months | 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. |
| LDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks | 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. |
| LDL Cholesterol (mg/dL) - Change from Baseline to 6 months | 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. |
| Height (centimeters) - Change from Baseline to 8 weeks | 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. |
| HDL Cholesterol (mg/dL) - Change from Baseline to 6 months | 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. |
| Triglycerides (mg/dL) - Change from Baseline to 8 weeks | 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. |
| Triglycerides (mg/dL) - Change from Baseline to 6 months | 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. |
| Hemoglobin A1c (%) - Change from Baseline to 8 weeks | 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. |
| Hemoglobin A1c (%) - Change from Baseline to 6 months | 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. |
| Dietary Fat Consumption Questionnaire - Change from Baseline to 8 weeks | 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. |
| Dietary Fat Consumption Questionnaire - Change from Baseline to 6 months | 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. |
| Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 8 weeks | 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 |
| Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 6 months | 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 |
| HDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks | 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. |
| Height (centimeters) - Change from Baseline to 6 months | 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. |
Outcome results
None listed