Assessment of Plant-based Program Using Shared Medical Appointment

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

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

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.

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

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.

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

Individual participant data (IPD) collected during the trial that underlie the results reported will be shared after de-identification.

Willett WC, Koplan JP, Nugent R, Dusenbury C, Puska P, Gaziano TA. Prevention of Chronic Disease by Means of Diet and Lifestyle Changes. In: Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, editors. Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2006. Chapter 44. Available from http://www.ncbi.nlm.nih.gov/books/NBK11795/

US Burden of Disease Collaborators; Mokdad AH, Ballestros K, Echko M, Glenn S, Olsen HE, Mullany E, Lee A, Khan AR, Ahmadi A, Ferrari AJ, Kasaeian A, Werdecker A, Carter A, Zipkin B, Sartorius B, Serdar B, Sykes BL, Troeger C, Fitzmaurice C, Rehm CD, Santomauro D, Kim D, Colombara D, Schwebel DC, Tsoi D, Kolte D, Nsoesie E, Nichols E, Oren E, Charlson FJ, Patton GC, Roth GA, Hosgood HD, Whiteford HA, Kyu H, Erskine HE, Huang H, Martopullo I, Singh JA, Nachega JB, Sanabria JR, Abbas K, Ong K, Tabb K, Krohn KJ, Cornaby L, Degenhardt L, Moses M, Farvid M, Griswold M, Criqui M, Bell M, Nguyen M, Wallin M, Mirarefin M, Qorbani M, Younis M, Fullman N, Liu P, Briant P, Gona P, Havmoller R, Leung R, Kimokoti R, Bazargan-Hejazi S, Hay SI, Yadgir S, Biryukov S, Vollset SE, Alam T, Frank T, Farid T, Miller T, Vos T, Barnighausen T, Gebrehiwot TT, Yano Y, Al-Aly Z, Mehari A, Handal A, Kandel A, Anderson B, Biroscak B, Mozaffarian D, Dorsey ER, Ding EL, Park EK, Wagner G, Hu G, Chen H, Sunshine JE, Khubchandani J, Leasher J, Leung J, Salomon J, Unutzer J, Cahill L, Cooper L, Horino M, Brauer M, Breitborde N, Hotez P, Topor-Madry R, Soneji S, Stranges S, James S, Amrock S, Jayaraman S, Patel T, Akinyemiju T, Skirbekk V, Kinfu Y, Bhutta Z, Jonas JB, Murray CJL. The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk Factors Among US States. JAMA. 2018 Apr 10;319(14):1444-1472. doi: 10.1001/jama.2018.0158.

Campbell EK, Fidahusain M, Campbell Ii TM. Evaluation of an Eight-Week Whole-Food Plant-Based Lifestyle Modification Program. Nutrients. 2019 Sep 3;11(9):2068. doi: 10.3390/nu11092068.

Wright N, Wilson L, Smith M, Duncan B, McHugh P. The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. Nutr Diabetes. 2017 Mar 20;7(3):e256. doi: 10.1038/nutd.2017.3.

Yokoyama Y, Levin SM, Barnard ND. Association between plant-based diets and plasma lipids: a systematic review and meta-analysis. Nutr Rev. 2017 Sep 1;75(9):683-698. doi: 10.1093/nutrit/nux030.

Springmann M, Clark MA, Rayner M, Scarborough P, Webb P. The global and regional costs of healthy and sustainable dietary patterns: a modelling study. Lancet Planet Health. 2021 Nov;5(11):e797-e807. doi: 10.1016/S2542-5196(21)00251-5. Epub 2021 Oct 27. Erratum In: Lancet Planet Health. 2021 Dec;5(12):e861.

Quek J, Lim G, Lim WH, Ng CH, So WZ, Toh J, Pan XH, Chin YH, Muthiah MD, Chan SP, Foo RSY, Yip J, Neelakantan N, Chong MFF, Loh PH, Chew NWS. The Association of Plant-Based Diet With Cardiovascular Disease and Mortality: A Meta-Analysis and Systematic Review of Prospect Cohort Studies. Front Cardiovasc Med. 2021 Nov 5;8:756810. doi: 10.3389/fcvm.2021.756810. eCollection 2021.

Baden MY, Liu G, Satija A, Li Y, Sun Q, Fung TT, Rimm EB, Willett WC, Hu FB, Bhupathiraju SN. Changes in Plant-Based Diet Quality and Total and Cause-Specific Mortality. Circulation. 2019 Sep 17;140(12):979-991. doi: 10.1161/CIRCULATIONAHA.119.041014. Epub 2019 Aug 12.

Scrafford CG, Bi X, Multani JK, Murphy MM, Schmier JK, Barraj LM. Health Economic Evaluation Modeling Shows Potential Health Care Cost Savings with Increased Conformance with Healthy Dietary Patterns among Adults in the United States. J Acad Nutr Diet. 2019 Apr;119(4):599-616. doi: 10.1016/j.jand.2018.10.002. Epub 2018 Dec 24.

Bolori P, Setaysh L, Rasaei N, Jarrahi F, Yekaninejad MS, Mirzaei K. Adherence to a healthy plant diet may reduce inflammatory factors in obese and overweight women-a cross-sectional study. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2795-2802. doi: 10.1016/j.dsx.2019.07.019. Epub 2019 Jul 26.

Menzel J, Biemann R, Longree A, Isermann B, Mai K, Schulze MB, Abraham K, Weikert C. Associations of a vegan diet with inflammatory biomarkers. Sci Rep. 2020 Feb 6;10(1):1933. doi: 10.1038/s41598-020-58875-x.

Brathwaite N, Fraser HS, Modeste N, Broome H, King R. Obesity, diabetes, hypertension, and vegetarian status among Seventh-Day Adventists in Barbados: preliminary results. Ethn Dis. 2003 Winter;13(1):34-9.

Kirsh SR, Aron DC, Johnson KD, Santurri LE, Stevenson LD, Jones KR, Jagosh J. A realist review of shared medical appointments: How, for whom, and under what circumstances do they work? BMC Health Serv Res. 2017 Feb 4;17(1):113. doi: 10.1186/s12913-017-2064-z.

Kirsh S, Watts S, Pascuzzi K, O'Day ME, Davidson D, Strauss G, Kern EO, Aron DC. Shared medical appointments based on the chronic care model: a quality improvement project to address the challenges of patients with diabetes with high cardiovascular risk. Qual Saf Health Care. 2007 Oct;16(5):349-53. doi: 10.1136/qshc.2006.019158.

Harland, J., and L. Garton. An update of the evidence relating to plant-based diets and cardiovascular disease, type 2 diabetes and overweight. Nutrition Bulletin. 2016; 41.4 : 323-338.

Jaacks LM, Kapoor D, Singh K, Narayan KM, Ali MK, Kadir MM, Mohan V, Tandon N, Prabhakaran D. Vegetarianism and cardiometabolic disease risk factors: Differences between South Asian and US adults. Nutrition. 2016 Sep;32(9):975-84. doi: 10.1016/j.nut.2016.02.011. Epub 2016 Mar 4.

http://www.sanantonio.gov/Portals/0/Files/health/News/Reports/StrategicPlan5-27-2017.pdf?ver=2017-05-30-162509-187

https://www.cdc.gov/nceh/tracking/topics/LifestyleRiskFactors.htm#:%7E:text=Four%20personal%20behaviors%20that%20can,use%2C%20and%20excessive%20alcohol%20use