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
Verified date | March 2024 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Health San Antonio, School of Nursing | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | Louise L Morrison Trust |
United States,
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
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 |
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