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Completed

NCT Number: NCT02548299

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition education

Other

Nutrition classes will be led by a registered dietician.

Cooking Lecture

Other

Cooking Demo

Other

Hands-on Cooking

Other

e-Coaching

Other

Primary outcomes

  1. Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 8 weeks

    Time frame: 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.

  2. Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 6 months

    Time frame: 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 outcomes

  1. Height (centimeters) - Change from Baseline to 8 weeks

    Time frame: 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.

  2. Height (centimeters) - Change from Baseline to 6 months

    Time frame: 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.

  3. Weight (kilograms) - Change from Baseline to 8 weeks

    Time frame: 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.

  4. Weight (kilograms) - Change from Baseline to 6 months

    Time frame: 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.

  5. Fasting Blood Glucose (mg/dL) - Change from Baseline to 8 weeks

    Time frame: 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.

  6. Fasting Blood Glucose (mg/dL) - Change from Baseline to 6 months

    Time frame: 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.

  7. Blood Pressure - Change from Baseline to 8 weeks

    Time frame: 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. Blood Pressure - Change from Baseline to 6 months

    Time frame: 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.

  9. Total Cholesterol (mg/dL) - Change from Baseline to 8 weeks

    Time frame: 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.

  10. Total Cholesterol (mg/dL) - Change from Baseline to 6 months

    Time frame: 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.

  11. LDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks

    Time frame: 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.

  12. LDL Cholesterol (mg/dL) - Change from Baseline to 6 months

    Time frame: 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.

  13. HDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks

    Time frame: 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.

  14. HDL Cholesterol (mg/dL) - Change from Baseline to 6 months

    Time frame: 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.

  15. Triglycerides (mg/dL) - Change from Baseline to 8 weeks

    Time frame: 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.

  16. Triglycerides (mg/dL) - Change from Baseline to 6 months

    Time frame: 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.

  17. Hemoglobin A1c (%) - Change from Baseline to 8 weeks

    Time frame: 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.

  18. Hemoglobin A1c (%) - Change from Baseline to 6 months

    Time frame: 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.

  19. Dietary Fat Consumption Questionnaire - Change from Baseline to 8 weeks

    Time frame: 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.

  20. Dietary Fat Consumption Questionnaire - Change from Baseline to 6 months

    Time frame: 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.

  21. Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 8 weeks

    Time frame: 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

  22. Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 6 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • The Honor Project Trust

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2015
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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