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Chronic DiseaseNCT05889715

Assessment of Plant-based Program Using Shared Medical Appointment

A study testing Green Wellness Program: Plants-2-Plate in people with Chronic Disease and Nutrition, Healthy, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Disease, Nutrition, Healthy
What is being tested?
Green Wellness Program: Plants-2-Plate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited States
Study dates
10 May 2023to 7 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT Health San Antonio, School of Nursing

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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

Read the detailed 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.

Being tested
Green Wellness Program: Plants-2-Plate
Keywords
Whole food plant-based nutrition, Primary care setting
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Green Wellness Program: Plants-2-PlateOther

    Also called Whole food, plant-based program

    A 6-month, intensive interprofessional program focused on a WFPB predominant eating pattern

Study groups in NCT05889715
Study groupRoleWhat they receive
Green Wellness Program: Plants-2-PlateExperimentalThe 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.
Receives: Other: Green Wellness Program: Plants-2-Plate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Cholesterol from blood chemistry panel

    Change in Total Cholesterol from program beginning to end

    Measured: Baseline to 6 months

  2. Low Density Lipoprotein (LDL) from blood chemistry panel

    Change in LDL-cholesterol from program beginning to end

    Measured: Baseline to 6 months

  3. HDL-Cholesterol from blood chemistry panel

    Change in HDL-cholesterol from program beginning to end

    Measured: Baseline to 6 months

  4. Triglycerides from blood chemistry panel

    Change in triglycerides from program beginning to end

    Measured: Baseline to 6 months

  5. Tumor necrosis factor-alfa (TNF-α) from blood inflammatory biomarker

    Change in TNF-α from program beginning to end

    Measured: Baseline to 6 months

  6. Interleukin (IL)-18 measurement from blood test

    Change in Interleukin (IL)-18 from program beginning to end

    Measured: Baseline to 6 months

  7. C-reactive protein (HsCRP) measurement from blood test

    Change in HsCRP from program beginning to end

    Measured: Baseline to 6 months

  8. Soluble Intercellular Adhesion Molecule-1 (sICAM1) measurement from blood test

    Change in sICAM1 from program beginning to end

    Measured: Baseline to 6 months

Secondary outcomes (6)

  1. Adherence to WFPB measurement

    Pattern of adherence is tracked by a mobile health device by number of days of adherence to program

    Measured: Baseline to 6 months

  2. Physical activity measurement

    Time spent daily on physical activity daily

    Measured: Baseline to 6 months

  3. Systolic Blood pressure measurement

    Change in Systolic blood pressure from program beginning to end

    Measured: Baseline to 6 months

  4. Diastolic Blood pressure measurement

    Change in Diastolic blood pressure from program beginning to end

    Measured: Baseline to 6 months

  5. Waist circumference measurement

    Change in waist circumference from program beginning to end

    Measured: Baseline to 6 months

  6. Weight measurement

    Change in weight from program beginning to end

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start10 May 2023
  3. Primary completion7 Feb 2024
  4. Study completion7 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889715
Sponsor's protocol ID
HSC20220903H
Status last verified
Mar 2024
First submitted
22 May 2023
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) collected during the trial that underlie the results reported will be shared after de-identification.

Publications

  • 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/

    PubMed 21250366

  • 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.

    PubMed 29634829

  • 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.

    PubMed 31484341

  • 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.

    PubMed 28319109

  • 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.

    PubMed 28938794

  • 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.

    PubMed 34715058

  • 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.

    PubMed 34805312

  • 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.

    PubMed 31401846

  • 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.

    PubMed 30591404

  • 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.

    PubMed 31405709

  • 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.

    PubMed 32029816

  • 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.

    PubMed 12723010

  • 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.

    PubMed 28160771

  • 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.

    PubMed 17913775

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Green Wellness Program: Plants-2-Plate in people with Chronic Disease and Nutrition, Healthy, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Cholesterol from blood chemistry panel (time frame: Baseline to 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889715, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.

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