Clinical trial NCT02548299: Cooking and Nutrition Education for Health Among Adults With Diabetes
Official title: Cooking and Nutrition Education for Health Among Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Cooking
Nutrition
Lifestyle Medicine
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Honor Project Trust
First posted: 2015-09-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Investigator-Designed Cooking Skills Questionnaire - Change from Baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Height (centimeters) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Height (centimeters) - Change from Baseline to 6 months
timeFrame: 6 months
measure: Weight (kilograms) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Weight (kilograms) - Change from Baseline to 6 months
timeFrame: 6 months
measure: Fasting Blood Glucose (mg/dL) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Fasting Blood Glucose (mg/dL) - Change from Baseline to 6 months
timeFrame: 6 months
measure: Blood Pressure - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Blood Pressure - Change from Baseline to 6 months
timeFrame: 6 months
measure: Total Cholesterol (mg/dL) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Total Cholesterol (mg/dL) - Change from Baseline to 6 months
timeFrame: 6 months
measure: LDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: LDL Cholesterol (mg/dL) - Change from Baseline to 6 months
timeFrame: 6 months
measure: HDL Cholesterol (mg/dL) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: HDL Cholesterol (mg/dL) - Change from Baseline to 6 months
timeFrame: 6 months
measure: Triglycerides (mg/dL) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Triglycerides (mg/dL) - Change from Baseline to 6 months
timeFrame: 6 months
measure: Hemoglobin A1c (%) - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Hemoglobin A1c (%) - Change from Baseline to 6 months
timeFrame: 6 months
measure: Dietary Fat Consumption Questionnaire - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Dietary Fat Consumption Questionnaire - Change from Baseline to 6 months
timeFrame: 6 months
measure: Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 8 weeks
timeFrame: 8 weeks
measure: Dietary Fiber, Fruit and Vegetable Consumption Questionnaire - Change from Baseline to 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Mladen Golubic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: