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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a plant-based diet might enhance health and nutrition. Participants will either attend weekly in-person classes with meal vouchers as part of the Nutritious Eating With Soul Dissemination and Implementation program or receive only meal vouchers from vegan soul food restaurants. The study will compare the effectiveness of each approach and evaluate the cost against health benefits such as weight change and healthier eating habits. African Americans with a body mass index (a measure of body fat based on height and weight) between 25 and 49.9, who are not already on a plant-based diet and can travel for classes, may be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore personal health improvements through dietary changes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that a plant-based diet is generally safe and easy for most people to follow. Studies have found that these diets can improve health without causing major side effects. In this trial, participants will be encouraged to follow a plant-based diet through the Nutritious Eating With Soul program.

The trial includes two groups: one will receive weekly classes and meal vouchers, while the other will receive only meal vouchers. The researchers aim to assess how these methods affect healthy eating and weight control.

Although specific safety data from past studies on this exact program is unavailable, plant-based diets are usually considered safe. They emphasize fruits, vegetables, grains, and beans, which are common in many healthy diets. Any minor issues typically relate to adjusting to new eating habits, such as changes in digestion.

Overall, the safety of the plant-based approach in this trial is supported by general evidence on plant-based diets, suggesting it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a plant-based diet could change the way we think about nutrition. Unlike typical dietary guidelines that might include animal products, this approach is entirely vegan, emphasizing plant-derived foods. Participants receive hands-on guidance through weekly classes, which helps them learn how to balance their nutritional needs within a vegan framework. This method not only aims to improve individual health but also offers a sustainable way to eat that could benefit the planet. The inclusion of restaurant vouchers also makes it more accessible and engaging for participants.

What evidence suggests that this trial's treatments could be effective for healthy nutrition?

Research has shown that a plant-based diet can significantly reduce the risk of health issues such as high blood pressure, diabetes, and high cholesterol. One study found that African American vegetarians and vegans experienced fewer of these problems compared to meat-eaters. In this trial, the Nutritious Eating With Soul program, a treatment arm, guides participants in following a vegan diet through classes. This program aims to enhance overall health by emphasizing whole, plant-based foods. Early results suggest that this diet aids in weight loss and improves eating habits. The program is designed to be easy to follow and effective, offering both dietary advice and practical meal ideas. Meanwhile, participants in the control arm receive meal vouchers without dietary guidance, allowing for a comparison of outcomes between the two groups. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Self-identify as African American

Body Mass Index between 25-49.9 kg/m2

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6952545/

The Nutritious Eating with Soul (NEW Soul) Study Research from the AHS-2 has found that compared with AA omnivores, AA vegetarians/vegans had significantly lower risk of hypertension, diabetes, and high total ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05659966

Study Details | NCT05659966 | Nutritious Eating with Soul ... The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31743793/

The Nutritious Eating with Soul (NEW Soul) Study - PubMed The study compares a vegan diet (whole foods) to a low-fat omnivorous diet, with weekly classes for the first six months, then bi-weekly for ...

4. newsoul.org newsoul.org/

Nutritious Eating with Soul (NEW Soul) We are a 12-week nutrition program, known as the Nutritious Eating with Soul (NEW Soul) study, hosted through the University of South Carolina.

5. researchgate.net researchgate.net/publication/337307851_The_Nutritious_Eating_with_Soul_NEW_Soul_Study_Study_design_and_methods_of_a_two-year_randomized_trial_comparing_culturally_adapted_soul_food_vegan_vs_omnivorous_diets_among_African_American_adults_at

The Nutritious Eating with Soul (NEW Soul) Study The Nutritious Eating with Soul (NEW Soul) Study: Study design and methods of a two-year randomized trial comparing culturally adapted soul food ...

6. prevention.sph.sc.edu prevention.sph.sc.edu/research/new-soul-2/

NEW Soul 2 | University of South Carolina Prevention ... The NEW Soul Dissemination and Implementation (NEW Soul D&I) study will examine the effectiveness and implementation of a behavioral plant-based dietary ...