An interventional study of TeleMOVE! and Culinary Rx in Hyperlipidemias, Overweight and Obesity and Diabetes, sponsored by Phoenix VA Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Phoenix VA Health Care System · Not applicable, Interventional, and Treatment
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).
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:
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
Behavioral: TeleMOVE!
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.
Behavioral: Culinary Rx
Active comparator- telehealth treatment program for weight management and health promotion
Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.
Change in Low-density lipoprotein (LDL)
Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)
Time frame: 90 days, 6 months and one year from baseline
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.
Time frame: 90 days, 6 months and one year from baseline
Change in carotid plaque
Plaque volume
Time frame: 90 days from baseline
Change in aortic pulse wave velocity
aortic pulse wave velocity
Time frame: 90 days from baseline
Change in Total Cholesterol
Fasting total cholesterol measured in milligrams per deciliter (mg/dl)
Time frame: 90 days, 6 months and one year from baseline
Change in Weight
Weight in kilograms measured with subject in light clothing without shoes
Time frame: 90 days, 6 months and one year from baseline
Change in Hemoglobin A1C (HgbA1c)
Hemoglobin A1c measured as %
Time frame: 90 days, 6 months and one year from baseline
Plan to share: No — The study start date was before January 18, 2017, so no plan is in place.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Phoenix VA Health Care System