Cooking and Nutrition Education for Health Among Adults With Diabetes
- Conditions
- Diabetes
- Registration Number
- NCT02548299
- Lead Sponsor
- The Cleveland Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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.
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.
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 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
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.
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.
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.
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.
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.
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 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 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