Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
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|ClinicalTrials.gov Identifier: NCT03330548|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemias Overweight and Obesity Diabetes||Behavioral: TeleMOVE! Behavioral: Culinary Rx||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The assessor for the imaging studies will be blinded to the study arms of the subjects.|
|Official Title:||Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors|
|Actual Study Start Date :||July 9, 2015|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Active Comparator: TeleMOVE!
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
Active comparator- telehealth treatment program for weight management and health promotion
Experimental: Culinary Rx
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
Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.
- Change in Low-density lipoprotein (LDL) [ Time Frame: 90 days, 6 months and one year from baseline ]Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)
- Change in Dietary pattern [ Time Frame: 90 days, 6 months and one year from baseline ]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.
- Change in carotid plaque [ Time Frame: 90 days from baseline ]Plaque volume
- Change in aortic pulse wave velocity [ Time Frame: 90 days from baseline ]aortic pulse wave velocity
- Change in Total Cholesterol [ Time Frame: 90 days, 6 months and one year from baseline ]Fasting total cholesterol measured in milligrams per deciliter (mg/dl)
- Change in Weight [ Time Frame: 90 days, 6 months and one year from baseline ]Weight in kilograms measured with subject in light clothing without shoes
- Change in Hemoglobin A1C (HgbA1c) [ Time Frame: 90 days, 6 months and one year from baseline ]Hemoglobin A1c measured as %
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330548
|Contact: Diane J Parrington, PhD||602-277-5551 ext firstname.lastname@example.org|
|United States, Arizona|
|Phoenix VA Health Care System||Recruiting|
|Phoenix, Arizona, United States, 85012|
|Contact: Diane J Parrington, PhD 602-277-5551 ext 7532|
|Principal Investigator:||Diane J Parrington, PhD||Phoenix VA Health Care System|