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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a whole food, plant-based diet affects weight loss and reduces heart disease risks in adults who are overweight or obese and have a chronic disease. Participants will follow a diet rich in vegetables, fruits, grains, and nuts while minimizing animal and processed foods. The trial also provides support for stress management, better sleep, and physical activity. It suits individuals who own a smartphone, are overweight, and have a chronic condition such as high blood pressure or diabetes. This program is part of the Green Wellness Program: Plants-2-Plate initiative. As an unphased trial, it offers participants the chance to contribute to valuable research on lifestyle changes that could improve health outcomes.

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 prior data suggests that the Green Wellness Program: Plants-2-Plate is safe for participants?

Research has shown that a plant-based diet, like the one in the Green Wellness Program, is generally easy for most people to follow. Studies have found that it can significantly improve health measures, such as body weight, for those with long-term health issues. This suggests the diet can aid in weight loss and enhance overall health without major safety concerns.

Participants have reported positive changes, particularly in consuming more healthy plant-based foods. The program also provides support for managing stress, improving sleep, and increasing exercise, all of which enhance overall well-being. No specific reports of negative effects from the diet itself have emerged, indicating it is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Green Wellness Program: Plants-2-Plate because it takes a fresh approach to managing chronic diseases through dietary changes. Unlike traditional treatments that often rely on medications, this program focuses on a whole food, plant-based eating pattern, emphasizing vegetables, fruits, legumes, whole grains, seeds, and nuts while minimizing animal and processed foods. Participants are encouraged to eat freely from these plant-based options, which could lead to improved health outcomes by naturally reducing inflammation and promoting heart health. Additionally, the program includes support for stress management, better sleep, and increased physical activity, offering a comprehensive lifestyle change rather than just a dietary shift. This holistic approach is what sets it apart and holds promise for long-term health benefits.

What evidence suggests that the Green Wellness Program: Plants-2-Plate is effective for reducing cardiovascular risk factors and weight loss?

Research has shown that plant-based diets can help manage long-term health issues like diabetes, heart disease, and obesity. One study found that a diet focused on whole, plant-based foods improved health markers and lowered Body Mass Index (BMI) in people with chronic illnesses. Additionally, a review of 32 studies found that plant-based diets can prevent chronic diseases and boost overall health. This trial will evaluate the Green Wellness Program: Plants-2-Plate, which emphasizes vegetables, fruits, beans, and whole grains while reducing animal and processed foods. Early results suggest that this way of eating not only aids in weight loss but also lowers heart disease risks. ^{1 2 6 7 8}

Who Is on the Research Team?

Christiane L Meireles, PhD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. wellness360.uthealthsa.org wellness360.uthealthsa.org/green-wellness-program-plants-2-plate/

Green Wellness Program: Plants-2-Plate People living with chronic conditions such as diabetes type 2, heart disease, hypertension or obesity may benefit from a plant-based diet. All individuals ...

2. withpower.com withpower.com/trial/phase-chronic-disease-6-2023-834c3

Plant-Based Diet Program for Chronic Disease A whole-foods, plant-based nutrition intervention significantly improved metabolic markers in 31 patients with chronic disease, showing reductions in BMI, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11890674/

Plant-Based Diets and Their Role in Preventive Medicine This systematic review synthesizes evidence from 32 longitudinal studies to evaluate the impact of plant-based diets on disease prevention and health outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6328339/

The Importance of Healthy Dietary Patterns in Chronic ... Many chronic diseases are preventable through life long practices of adhering to healthy dietary patterns, engaging in physical activity and maintaining ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/08901171251371456

Screening for Chronic Conditions During Wellness ... The prevalence of susceptibility for diabetes is 17.03% (18.29%) for one-time (frequent) participants, for high blood pressure is 44.76% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11141270/

Advancing Lifestyle Medicine in New York City's Public Health ... Chronic diseases are the leading cause of death and disability in the United States, and much of this burden can be attributed to lifestyle and ...

7. mdpi.com mdpi.com/2072-6643/15/13/2857

Patient-Reported Outcomes from a Pilot Plant-Based ... Most salient in our findings, however, is the overall positive pattern of improvement in the consumption of healthy plant-based items individually, as well as ...

8. deloitte.com deloitte.com/us/en/insights/industry/health-care/us-consumers-and-healthy-eating.html

US consumers and healthy eating | Deloitte Insights A Deloitte survey finds that most US consumers want to use food to help manage their health, creating opportunities for health and business leaders.