228 Participants Needed

Plant-Based Diet for Healthy Nutrition

GM
JA
Overseen ByJohn A Bernhart, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.16789

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.110111213

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
See 2 more

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
See 5 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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: ControlActive Control1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

A whole-food plant-based experiential education program for health care providers results in personal and professional changes. [2021]
Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting. [2023]
Protocol and Preliminary Results of the Nutritarian Women's Health Study: A Longitudinal Effectiveness-Implementation Hybrid Study Assessing Dietary Intake and Health Outcomes. [2021]
Healthy Teaching Kitchen Programs: Experiential Nutrition Education Across Veterans Health Administration, 2018. [2020]
Impact of a Whole-Foods, Plant-Based Nutrition Intervention on Patients Living with Chronic Disease in an Underserved Community. [2022]
A scoping review of approaches used to develop plant-based diet quality indices. [2023]
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]
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]
Health Benefits of a 16-Week Whole Food, High Fiber, Plant Predominant Diet among U.S. Employees. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
A Plant-Based Nutrition Program. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Convergence of plant-rich and plant-only diets. [2018]
Sustainability analysis of Finnish pre-schoolers' diet based on targets of the EAT-Lancet reference diet. [2022]
Nutritional Assessment of the Symptomatic Patient on a Plant-Based Diet: Seven Key Questions. [2023]
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