Plant-Based Diet for Healthy Nutrition
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)?
Is a plant-based diet generally safe for humans?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for changes in body weight and diet quality, and cost-effectiveness is assessed.
Treatment Details
Interventions
- Nutritious Eating With Soul Dissemination and Implementation
- Voucher only
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of South Carolina
Lead Sponsor