Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
Condition: Hyperlipidemias; Overweight and Obesity; Diabetes
MeSH terms: Overweight; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        1. 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.

        2. (Part 1) The effectiveness of a five-week whole-food, plant-strong diet on
           participants':

             1. Cardiovascular risk factors: Low-Density Lipoprotein, (LDL-C), High-Density
                Lipoprotein (HDL), Triglycerides (TG), Total Cholesterol (T Chol), C-Reactive
                Protein (CRP), basic chemistry panel, blood pressure, weight, waist circumference,
                and percent body fat.

             2. Dietary pattern, particularly the 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-food) are
                increased from baseline intake, and the nutrient composition (percent of calories
                from protein, fat, carbohydrate, and amount of fiber) of the diet changes.

        3. (Part 3) The effectiveness of completing Culinary Rx as compared to TeleMOVE! for 90
           days on participants':

             1. Cardiovascular risk factors: Low-Density Lipoprotein, (LDL-C), High-Density
                Lipoprotein (HDL), Triglycerides (TG), Total Cholesterol (T Chol), HgbA1c, blood
                pressure, body mass index, weight, waist to hip ratio, and. medication usage (e.g.,
                blood pressure, hypoglycemic, lipid lowering and anti-depressants).

             2. Dietary pattern, particularly the 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-food) are
                increased from baseline intake, and the nutrient composition (percent of calories
                from protein, fat, carbohydrate, and amount of fiber) of the diet changes.

             3. Long-term lifestyle changes as measured by sustainability of dietary pattern and
                cardiovascular risk changes that occurred at 90 days and were still present at six
                months and one year, (excluding change in plaque inflammation and endothelial
                function).

        4. 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).

             1. Correlation analysis of aortic/carotid FDG uptake versus Framingham risk score from
                consecutive subjects who underwent PET FDG for clinical indications at Phoenix VA
                from January 1, 2010-May 31, 2015.

             2. Change in aortic/carotid plaque FDG uptake, plaque volume and aortic pulse wave
                velocity (measure of aortic/arterial stiffness) at baseline and following 90-day
                PSD using Culinary Rx, or TeleMOVE! (pilot prospective study).
    

Intervention name(s): TeleMOVE!; Culinary Rx
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
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)
Primary purpose: Treatment
Keywords: Plant-based diet; Hyperlipidemia; Diabetes; Overweight; Veterans