Assessment of Plant-based Program Using Shared Medical Appointment

Study Overview
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Brief Summary
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Evaluation of the impact of a whole food, plant-based (WFPB) program using shared medical appointments (SMAs) on reducing cardiovascular risk factors and weight loss in overweight/obese adults with at least one chronic disease

Detailed Description
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The study will use a single-arm with participants enrolled in three groups of 15 each (n=45) into the Green Wellness Program: Plants-2-Plate, an established program focusing on WFPB predominant eating pattern in an academic primary care setting. The program will offer 14 SMAs in a period of 6 months. Participants will attend the SMA weekly for 3 months, followed by a monthly SMA for the last 3 months of the intervention period. In the first session, participants will receive information about the program, and establish a health goal to be met at the end of the program. Each weekly SMA will have a nutrition education lesson, and feedback from the FNP, RN and RD after a brief assessment on health, medication adjustment, food choices, and shared ideas and experiences among the participants. At the end of the session, participants will set a small health goal to be followed during the week with assistance from the inter-professional team. The WFPB dietary approach includes vegetables, fruits, legumes, whole grains, seeds, nuts in small portion, elimination of all or most of animal foods, and reduction of processed food. Participants will eat ad libitum. In addition, they will receive support to manage stress, improve quality of sleep, and increase physical activity during the SMA.

Official Title
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An Interprofessional-led Model of Care to Prevent and Treat Chronic Diseases Using a Whole Food, Plant-based Nutrition Program in a Primary Care Setting

Conditions
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Chronic Disease, Nutrition, Healthy

Intervention / Treatment
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* Other: Green Wellness Program: Plants-2-Plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women >18 years Either overweight (BMI > 25kgm-2) or obese (BMI >30 kgm-2) Diagnosis of one or more chronic diseases Own a smartphone or tablet that has reliable interned/data access Agrees to comply with all study requirements Can speak and understand English Exclusion Criteria: Diagnosis of cancer Previous participant in Green Wellness program: Plants-2-Plate Pregnant or planning to become pregnant Breastfeeding Concurrent weight loss program Plans to leave the city or USA for over 2 weeks within 6 months of enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The study will use a single-arm with participants to be enrolled in three groups of 15 each (n=45) into the Green Wellness Program: Plants-2-Plate
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green Wellness Program: Plants-2-Plate<br>The Green Wellness Program:Plants-2-Plate is an established program focusing on whole food plant-based predominant eating pattern in academic primary care setting.The dietary approach includes vegetables, fruits, legumes, whole grains, seeds, nuts in small portion, elimination of all or most of animal foods, and reduction of processed foods. Participants will eat ad libitum. In addition, they will receive support to manage stress, improve quality of sleep, and increase physical activity during the SMA. | Other: Green Wellness Program: Plants-2-Plate<br>* A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern<br>* Other names: Whole food, plant-based program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol from blood chemistry panel | Change in Total Cholesterol from program beginning to end | Baseline to 6 months | 
| Low Density Lipoprotein (LDL) from blood chemistry panel | Change in LDL-cholesterol from program beginning to end | Baseline to 6 months | 
| HDL-Cholesterol from blood chemistry panel | Change in HDL-cholesterol from program beginning to end | Baseline to 6 months | 
| Triglycerides from blood chemistry panel | Change in triglycerides from program beginning to end | Baseline to 6 months | 
| Tumor necrosis factor-alfa (TNF-α) from blood inflammatory biomarker | Change in TNF-α from program beginning to end | Baseline to 6 months | 
| Interleukin (IL)-18 measurement from blood test | Change in Interleukin (IL)-18 from program beginning to end | Baseline to 6 months | 
| C-reactive protein (HsCRP) measurement from blood test | Change in HsCRP from program beginning to end | Baseline to 6 months | 
| Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test | Change in sICAM1 from program beginning to end | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to WFPB measurement | Pattern of adherence is tracked by a mobile health device by number of days of adherence to program | Baseline to 6 months | 
| Physical activity measurement | Time spent daily on physical activity daily | Baseline to 6 months | 
| Systolic Blood pressure measurement | Change in Systolic blood pressure from program beginning to end | Baseline to 6 months | 
| Diastolic Blood pressure measurement | Change in Diastolic blood pressure from program beginning to end | Baseline to 6 months | 
| Waist circumference measurement | Change in waist circumference from program beginning to end | Baseline to 6 months | 
| Weight measurement | Change in weight from program beginning to end | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whole food plant-based nutrition, Primary care setting