Cooking and Nutrition Education for Health Among Adults With Diabetes

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02548299
Collaborator
The Honor Project Trust (Other)
45
3
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nutrition Education
  • Other: Cooking Lecture
  • Other: Cooking Demo
  • Other: Hands-on Cooking
  • Other: e-Coaching
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cooking and Nutrition Education for Health Among Adults With Diabetes
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

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: Cooking Demo

Other: e-Coaching

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: Hands-on Cooking

Other: e-Coaching

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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

  22. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The Cleveland Clinic
  • The Honor Project Trust

Investigators

  • Principal Investigator: Mladen Golubic, MD, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Linda Libertini, Research Coordinator, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02548299
Other Study ID Numbers:
  • 14-1607
First Posted:
Sep 14, 2015
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Keywords provided by Linda Libertini, Research Coordinator, The Cleveland Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022