Assessment of Plant-based Program Using Shared Medical Appointment

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05889715
• Other study ID #: HSC20220903H
• Status: Completed
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: February 7, 2024

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• Green Wellness Program: Plants-2-Plate
A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern

Locations

Country	Name	City	State
United States	UT Health San Antonio, School of Nursing	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Louise L Morrison Trust

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. Epu — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/s12913-017-206 — View Citation

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. — View Citation

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 Rev — View Citation

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. 20 — View Citation

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. Er — View Citation

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, Sant — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol from blood chemistry panel	Change in Total Cholesterol from program beginning to end	Baseline to 6 months
Primary	Low Density Lipoprotein (LDL) from blood chemistry panel	Change in LDL-cholesterol from program beginning to end	Baseline to 6 months
Primary	HDL-Cholesterol from blood chemistry panel	Change in HDL-cholesterol from program beginning to end	Baseline to 6 months
Primary	Triglycerides from blood chemistry panel	Change in triglycerides from program beginning to end	Baseline to 6 months
Primary	Tumor necrosis factor-alfa (TNF-a) from blood inflammatory biomarker	Change in TNF-a from program beginning to end	Baseline to 6 months
Primary	Interleukin (IL)-18 measurement from blood test	Change in Interleukin (IL)-18 from program beginning to end	Baseline to 6 months
Primary	C-reactive protein (HsCRP) measurement from blood test	Change in HsCRP from program beginning to end	Baseline to 6 months
Primary	Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test	Change in sICAM1 from program beginning to end	Baseline to 6 months
Secondary	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
Secondary	Physical activity measurement	Time spent daily on physical activity daily	Baseline to 6 months
Secondary	Systolic Blood pressure measurement	Change in Systolic blood pressure from program beginning to end	Baseline to 6 months
Secondary	Diastolic Blood pressure measurement	Change in Diastolic blood pressure from program beginning to end	Baseline to 6 months
Secondary	Waist circumference measurement	Change in waist circumference from program beginning to end	Baseline to 6 months
Secondary	Weight measurement	Change in weight from program beginning to end	Baseline to 6 months

External Links

•   CDC website
•   CDC website
•   CDC website
•   Strategic Health Plan of the City of San Antonio