Plant-Based Diet Program for Chronic Disease

Overseen By Heidi Benavides, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Cancer, Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 6 months

47 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Green Wellness Program: Plants-2-Plate for chronic disease?

Research shows that a whole-food, plant-based diet can improve health outcomes for people with chronic diseases like diabetes, heart disease, and obesity. Studies have found that such diets can lower blood pressure, reduce cholesterol levels, and help with weight loss, which are all beneficial for managing chronic conditions. ^{1 2 3 4 5}

Is a plant-based diet program safe for humans?

Research on plant-based diet programs, like the Open Source Wellness model and other similar interventions, shows they are generally safe for humans. Participants in these programs have experienced health benefits such as weight loss, reduced blood pressure, and improved cholesterol levels, with no significant safety concerns reported. ^{2 5 6 7 8}

How does the Green Wellness Program: Plants-2-Plate treatment differ from other treatments for chronic disease?

The Green Wellness Program: Plants-2-Plate is unique because it focuses on a whole-food, plant-based diet, which has been shown to improve health outcomes like weight loss and reduced blood pressure and cholesterol levels. Unlike other treatments that may rely on medication, this program emphasizes lifestyle changes and dietary habits to manage chronic diseases. ^{2 7 9 10 11}

What is the purpose of this trial?

This trial tests a plant-based diet program with group medical meetings to help overweight or obese adults with chronic diseases improve their health. Participants eat mostly plants and whole foods, get regular support from healthcare professionals, and work on managing stress, sleeping better, and being more active.

Research Team

Christiane L Meireles, PhD

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

This trial is for men and women over 18 who are overweight or obese, have at least one chronic disease, can use a smartphone or tablet with internet, and will follow the study rules. They must speak English.

Inclusion Criteria

I am older than 18 years.

Agrees to comply with all study requirements

Own a smartphone or tablet that has reliable interned/data access

Exclusion Criteria

Breastfeeding

I have been diagnosed with cancer.

I am currently enrolled in a weight loss program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Green Wellness Program: Plants-2-Plate, attending weekly shared medical appointments for 3 months, followed by monthly appointments for another 3 months.

6 months

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Green Wellness Program: Plants-2-Plate

Trial Overview The trial tests the 'Plants-2-Plate' program which promotes whole food, plant-based nutrition through group medical appointments to see if it lowers heart risk factors and helps with weight loss in adults.

Participant Groups

Group I: Green Wellness Program: Plants-2-Plate Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Louise L Morrison Trust

Collaborator

Trials

1

Recruited

50+

Findings from Research

A whole-foods, plant-based nutrition intervention significantly improved metabolic markers in 31 patients with chronic disease, showing reductions in BMI, systolic blood pressure, total cholesterol, and LDL levels, all with high statistical significance (P < .01).

The intervention was particularly effective for patients with abnormal preintervention metrics, indicating that group visits promoting this dietary approach can help reduce chronic disease burden in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Whole-Foods, Plant-Based Nutrition Intervention on Patients Living with Chronic Disease in an Underserved Community. Bansal, S., Connolly, M., Harder, T.[2022]

A study involving 200 medical trainees and 52 patients found that nearly half of the patients were open to trying a whole-foods, plant-based (WFPB) diet for managing chronic diseases, indicating a potential for dietary intervention in improving health outcomes.

While over half of the trainees were willing to recommend a WFPB diet, they expressed concerns about its acceptability and feasibility, highlighting the need for medical providers to address their assumptions and provide better support for patients considering dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Foods, Plant-Based Diet Perceptions of Medical Trainees Compared to Their Patients: A Cross-Sectional Pilot Study. Morton, KF., Pantalos, DC., Ziegler, C., et al.[2023]

In a pilot program involving 17 participants, the adoption of a Whole Food Plant-based (WFPB) diet resulted in significant weight loss (4.3 kg) and improvements in cholesterol levels, including a decrease in total cholesterol and triglycerides, and an increase in HDL (good cholesterol).

The program, which included educational sessions led by a gastroenterologist, demonstrated the potential effectiveness of WFPB diets in a clinical setting, particularly for patients with conditions like hyperlipidemia and hypertension, suggesting a need for larger-scale studies to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. Ganguli, SC., Russell, LA., Tsoi, KS.[2023]

Participants in the Full Plate Living (FPL) program, which promotes a whole food plant-predominant diet, showed significant improvements in eating behaviors and health measures over 16 weeks, including increased fruit and vegetable intake and an average weight loss of 3.5 pounds.

The program positively affected self-perceived health, energy levels, and confidence in making healthy food choices, with benefits observed across different generational cohorts, suggesting its effectiveness as a corporate wellness initiative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Benefits of a 16-Week Whole Food, High Fiber, Plant Predominant Diet among U.S. Employees. Kelly, R., Hanus, A., Payne-Foster, P., et al.[2023]

In a study of 8041 middle-aged adults over a median follow-up of 13 years, adherence to plant-based diet indices (oPDI, hPDI, and provegetarian diet) was linked to a 12-16% lower risk of developing hypertension, indicating their potential protective effect against this condition.

Conversely, higher adherence to the unhealthy PDI (uPDI) was associated with a 13% increased risk of hypertension, highlighting the importance of diet quality in managing health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operational Differences in Plant-Based Diet Indices Affect the Ability to Detect Associations with Incident Hypertension in Middle-Aged US Adults. Kim, H., Rebholz, CM., Garcia-Larsen, V., et al.[2023]

The Healthy Eating Lifestyle Program (HELP) showed no excess weight gain in overweight or obese Hispanic/Latino children aged 5-12, indicating its potential effectiveness in weight management.

Parents and guardians participating in the program experienced a significant decrease in BMI, particularly among men, suggesting that culturally tailored, family-centered plant-based diet interventions can enhance pediatric weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating an Increase in Plant-Based Food Choices into a Model of Culturally Responsive Care for Hispanic/Latino Children and Adults Who Are Overweight/Obese. Singh, PN., Steinbach, J., Nelson, A., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of a Whole-Foods, Plant-Based Nutrition Intervention on Patients Living with Chronic Disease in an Underserved Community. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A whole-food, plant-based program in an African American faith-based population. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Whole-Foods, Plant-Based Diet Perceptions of Medical Trainees Compared to Their Patients: A Cross-Sectional Pilot Study. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Implementation of a Whole Food Plant Based Diet in a Food as Prevention Program in a Resource Constrained Environment. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Group Medical Visits 2.0: The Open Source Wellness Behavioral Pharmacy Model. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Health Benefits of a 16-Week Whole Food, High Fiber, Plant Predominant Diet among U.S. Employees. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of an Eight-Week Whole-Food Plant-Based Lifestyle Modification Program. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Operational Differences in Plant-Based Diet Indices Affect the Ability to Detect Associations with Incident Hypertension in Middle-Aged US Adults. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Meal Planning Program to Reduce Barriers and Improve Diet Quality in Worksite Wellness Center Members. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Massachusetts General Hospital Revere Food Pantry: Addressing hunger and health at an academic medical center community clinic. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Incorporating an Increase in Plant-Based Food Choices into a Model of Culturally Responsive Care for Hispanic/Latino Children and Adults Who Are Overweight/Obese. [2021]