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| Name | Class |
|---|---|
| Rouxbe Online Culinary School | UNKNOWN |
| Carl T. Hayden Medical Research Foundation | UNKNOWN |
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The purpose of this study is to conduct a preliminary test of the effectiveness of various educational interventions to promote adoption of a whole-food, plant-strong diet and reduce specific cardiovascular risk factors in Veterans, and subsequently perform a preliminary pilot study on whether this dietary approach will change plaque inflammation and endothelial function.
The purpose of this study is to conduct a preliminary test of the effectiveness of various educational interventions to promote adoption of a whole-food, plant-strong diet and reduce specific cardiovascular risk factors in Veterans, and subsequently perform a preliminary pilot study on whether this dietary approach will change plaque inflammation and endothelial function. The specific aims are to conduct a preliminary examination of:
The feasibility of Veterans to adopt a whole-food, plant-strong diet within five weeks, following a plant-strong protocol, or within 90 days following a Plant Strong Diet (PSD) using Culinary Rx, or by TeleMOVE! (standard of care control). Feasibility factors will evaluate acceptability and practicality by a measure of the recruitment process, attrition rate, reasons for dropping, perceived benefit, and comparison of dietary pattern changes before and after the intervention.
a. Acceptability of a plant-strong diet.
(Part 1) The effectiveness of a five-week whole-food, plant-strong diet on participants':
(Part 3) The effectiveness of completing Culinary Rx as compared to TeleMOVE! for 90 days on participants':
Establish the ability of Positron Emission Tomography 18F-fluorodeoxyglucose radiopharmaceutical and magnetic resonance imaging (PET FDG-MRI) to assess serial change in plaque inflammation and plaque volume (Part 2) and then perform a pilot test to assess whether a 90-day PSD using Culinary Rx, or TeleMOVE! reduces plaque inflammation using FDG uptake on PET scan and structural changes on MRI (Part 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TeleMOVE! | Active Comparator | Veterans randomized to the control arm will participate in TeleMOVE!, an arm of the Management of Overweight Veterans (MOVE!) program. TeleMOVE! is telehealth treatment program within the VA designed to improve the lives of Veterans by assisting with weight management and health promotion. This program includes daily interaction with in-home messaging technologies and clinician contact as needed |
|
| Culinary Rx | Experimental | Veterans randomized to the experimental arm will participate in Culinary Rx. Culinary Rx is an online instructional cooking and nutrition course that healthcare professionals can prescribe to patients who need to transition away from a Standard American Diet to a more health-supportive, whole foods, plant-based lifestyle. In partnership with The Plantrician Project, this course will focus on teaching the foundational cooking skills needed for long-term behavioral change, coupled with lifestyle education around nutrition and resources that will help users successfully face the many challenges inherent to dietary change. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TeleMOVE! | Behavioral | Active comparator- telehealth treatment program for weight management and health promotion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low-density lipoprotein (LDL) | Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl) | 90 days, 6 months and one year from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary pattern | Degree to which meat, fish, dairy and added oils are decreased or eliminated from the dietary pattern; as well as the degree to which the consumption of fruits and vegetables (particularly whole-foods) are increased from baseline intake. | 90 days, 6 months and one year from baseline |
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Inclusion Criteria:
Inclusion criteria: U.S. Veterans only
For the FDG-PET-MRI subset/portion of the study, there are additional inclusion criteria:
Inclusion criteria:
Exclusion Criteria:
For the FDG-PET-MRI subset/portion of the study, there are additional exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane J Parrington, PhD | Phoenix VA Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Health Care System | Phoenix | Arizona | 85012 | United States |
The study start date was before January 18, 2017, so no plan is in place.
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050177 | Overweight |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Subjects will be randomized 2:1 into Culinary Rx or TeleMOVE! prior to baseline measures. We plan to enroll a subset of the 80 participants to undergo a PET-MRI sub-study (total of 21 participants). This cohort requires participants to have a pooled cohort risk score of ≥ 7.5%, be willing and able to undergo FDG-PET-MRI. [The ACC/AHA pooled risk calculator utilizes information such as age, lipid profile, hypertension to estimate 10 year risk of ASCVD.](streamdown:incomplete-link)
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The assessor for the imaging studies will be blinded to the study arms of the subjects.
| Culinary Rx | Behavioral | Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle. |
|
| Change in carotid plaque |
Plaque volume |
| 90 days from baseline |
| Change in aortic pulse wave velocity | aortic pulse wave velocity | 90 days from baseline |
| Change in Total Cholesterol | Fasting total cholesterol measured in milligrams per deciliter (mg/dl) | 90 days, 6 months and one year from baseline |
| Change in Weight | Weight in kilograms measured with subject in light clothing without shoes | 90 days, 6 months and one year from baseline |
| Change in Hemoglobin A1C (HgbA1c) | Hemoglobin A1c measured as % | 90 days, 6 months and one year from baseline |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |