Plant-Based Diet for Healthy Nutrition

Overseen By John A Bernhart, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Diabetes, Pregnancy, Eating disorder, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

228 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have diabetes controlled by medication, you are not eligible to participate.

What data supports the effectiveness of the treatment Nutritious Eating With Soul Dissemination and Implementation (NEW Soul)?

Research shows that plant-based diets can improve mood, energy, and weight loss, and reduce the risk of diet-related diseases. Programs teaching plant-based nutrition have helped people increase their knowledge, overcome barriers, and improve health markers like blood pressure and cholesterol. ^{1 2 3 4 5}

Is a plant-based diet generally safe for humans?

Research on plant-based diets, including whole food plant-based diets, suggests they are generally safe for humans. Studies have shown improvements in mood, energy, and weight loss, with no significant safety concerns reported. ^{1 6 7 8 9}

How is the NEW Soul treatment different from other treatments for healthy nutrition?

The NEW Soul treatment is unique because it focuses on a plant-based diet, which has been shown to improve health and well-being quickly, and includes an experiential component where participants learn and experience the benefits firsthand, potentially influencing their future dietary choices and patient counseling. ^{1 10 11 12 13}

What is the purpose of this trial?

The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and implementation of community-delivered, 3-month NEW Soul program among participants (N=228). Using a randomized design, the investigators will assess effectiveness of two delivery approaches: (1) In-person, live weekly classes with restaurant vouchers (intervention) or (2) restaurant voucher-only (active control). The investigators will also conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher-only with the outcome of cost/change in weight, healthy eating index, and quality adjusted life year. Lastly, the investigators will examine the implementation of the NEW Soul study with participants and intervention staff.

Eligibility Criteria

This trial is for African American individuals aged 18-65 with a BMI of 25-49.9 who are not currently on a plant-based diet or in another weight loss program. Participants must be able to attend classes at the restaurant and all monitoring visits, and cannot have diabetes controlled by medication or be pregnant/breastfeeding.

Inclusion Criteria

I can attend all required appointments and classes.

I can travel to a restaurant for classes.

Self-identify as African American

Exclusion Criteria

I am under 18 years old.

Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)

Currently following a plant-based diet

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly group classes and restaurant vouchers for 3 months. The intervention group follows a plant-based diet with guidance, while the control group receives vouchers only.

12 weeks

12 visits (in-person for intervention group), 1 visit (in-person for control group)

Follow-up

Participants are monitored for changes in body weight and diet quality, and cost-effectiveness is assessed.

4 weeks

Treatment Details

Interventions

• Nutritious Eating With Soul Dissemination and Implementation
• Voucher only

Trial Overview The study tests the effectiveness of a community-delivered, 3-month NEW Soul program promoting healthy nutrition through two methods: in-person weekly classes with restaurant vouchers versus receiving only the vouchers. The impact on weight, eating habits, and quality of life will also be analyzed for cost-effectiveness.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The intervention condition participants will be instructed to follow a plant-based diet. The intervention participants will receive weekly group classes for 3 months at a local restaurant and will receive guidance on how to choose foods to meet their nutrient needs that fit within the vegan diet. The intervention participants will receive a voucher each week for a free plant-based meal at the restaurant.

Group II: Control Active Control 1 Intervention

Participants in the active control condition will receive meal vouchers to the restaurant. The active control condition participants will not receive any instruction to follow a particular diet or support. Participants in this condition will receive all intervention material and attend a class at the end of the study to learn about the intervention diet.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Findings from Research

A 3-week experiential education program for 30 healthcare providers led to significant improvements in their knowledge and acceptance of a whole-food plant-based (WFPB) diet, which is known to reduce the risk of diet-related diseases.

Participants not only adopted a WFPB diet themselves, resulting in weight loss and improved mood and energy, but also reported increased confidence in counseling patients about this dietary pattern, suggesting a potential for broader patient education on WFPB diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A whole-food plant-based experiential education program for health care providers results in personal and professional changes. Lessem, A., Gould, SM., Evans, J., et al.[2021]

A pilot plant-based lifestyle medicine program in a safety-net healthcare system led to significant improvements in patient-reported outcomes, including a 7.2% increase in nutrition knowledge and a 12.2% increase in participants reporting good or very good sleep quality after 6 months.

Participants also experienced a reduction in barriers to adopting a plant-based diet and increased physical activity, highlighting the effectiveness of lifestyle medicine interventions in promoting healthier behaviors among low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting. Massar, RE., McMacken, M., Kwok, L., et al.[2023]

The online Nutritarian diet intervention program was found to be feasible and effective in reducing the risk of chronic disease among women, as indicated by initial decreases in body mass index and waist-to-height ratio for at-risk participants.

Despite some decline in dietary adherence over time, the study suggests that implementing a micronutrient-dense plant-rich diet can have significant health benefits, highlighting its potential for clinical and public health applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol and Preliminary Results of the Nutritarian Women's Health Study: A Longitudinal Effectiveness-Implementation Hybrid Study Assessing Dietary Intake and Health Outcomes. Sutliffe, JT., Gardner, JC., Wetzel, WS., et al.[2021]

The Healthy Teaching Kitchen (HTK) program, implemented by the Veterans Health Administration, has been found to be acceptable and feasible for veterans, providing interactive nutrition and culinary education.

Participants in the HTK program reported increased self-efficacy for making dietary changes, suggesting that the program empowers veterans to improve their dietary and cooking habits, potentially leading to better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Teaching Kitchen Programs: Experiential Nutrition Education Across Veterans Health Administration, 2018. Black, M., LaCroix, R., Hoerster, K., et al.[2020]

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 review identified 35 unique plant-based diet quality indices from 137 studies, highlighting that most were developed based on epidemiological evidence linking food consumption to health outcomes.

The majority of these indices effectively differentiated between healthy and unhealthy plant-based foods, and were primarily validated for construct validity and reliability, emphasizing the importance of rigorous methodology in dietary assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of approaches used to develop plant-based diet quality indices. Marchese, LE., McNaughton, SA., Hendrie, GA., et al.[2023]

A community-based dietary program using a whole food plant-based (WFPB) diet resulted in a significant reduction in BMI after 6 months, with an average decrease of 4.4 kg/m² compared to only 0.4 kg/m² in the control group.

Participants following the WFPB diet also experienced a meaningful reduction in cholesterol levels, achieving a significant decrease at 12 months, with no serious harms reported, indicating the diet's safety and potential efficacy for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. Wright, N., Wilson, L., Smith, M., et al.[2018]

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]

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]

Nurses at three community health clinics followed a plant-based diet for 21 days as part of a nutrition educational program, which significantly improved their knowledge and personal health outcomes.

The program's experiential approach not only benefited the nurses but also has the potential to influence their patient care and teaching, promoting the importance of nutrition in preventive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Plant-Based Nutrition Program. Evans, J., Magee, A., Dickman, K., et al.[2018]

Plant-only diets, such as vegan and fruitarian, can be nutritionally adequate and beneficial for health, especially when they are well-planned to meet all nutrient requirements, as discussed by experts at the Third International Congress on Vegetarian Nutrition.

Both plant-only and plant-based diets have been shown to reduce the risk of chronic diseases, indicating that with the right planning and supplementation, these diets can be as safe and healthful as omnivorous diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convergence of plant-rich and plant-only diets. Dwyer, J.[2018]

A study of Finnish preschoolers (ages 3-6) revealed that their diets significantly under-consumed healthy food groups like whole grains, vegetables, and legumes, while over-consuming red meat, dairy, and added sugars, indicating a need for dietary changes.

To align with the EAT-Lancet reference diet, Finnish children's diets require major adjustments, specifically increasing whole grains and legumes while reducing red meat and dairy consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustainability analysis of Finnish pre-schoolers' diet based on targets of the EAT-Lancet reference diet. Bäck, S., Skaffari, E., Vepsäläinen, H., et al.[2022]

Whole food plant-based diets, including vegan and vegetarian options, are nutritionally sufficient and can provide health benefits, but poorly designed versions may lead to significant nutritional deficiencies.

Healthcare practitioners should assess patients on plant-based diets by considering seven key nutrient concerns, which can help ensure that patients maintain a balanced and complete diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Assessment of the Symptomatic Patient on a Plant-Based Diet: Seven Key Questions. Plotnikoff, GA., Dobberstein, L., Raatz, S.[2023]

References

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

A whole-food plant-based experiential education program for health care providers results in personal and professional changes. [2021]

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

Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting. [2023]

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

Protocol and Preliminary Results of the Nutritarian Women's Health Study: A Longitudinal Effectiveness-Implementation Hybrid Study Assessing Dietary Intake and Health Outcomes. [2021]

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

Healthy Teaching Kitchen Programs: Experiential Nutrition Education Across Veterans Health Administration, 2018. [2020]

5. 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]

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

A scoping review of approaches used to develop plant-based diet quality indices. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. [2018]

8. 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]

9. 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]

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

A Plant-Based Nutrition Program. [2018]

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

Convergence of plant-rich and plant-only diets. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

Sustainability analysis of Finnish pre-schoolers' diet based on targets of the EAT-Lancet reference diet. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Assessment of the Symptomatic Patient on a Plant-Based Diet: Seven Key Questions. [2023]