Nutritious Eating With Soul Dissemination and Implementation

NEW Soul D&I: Expanding the Reach of the Nutritious Eating With Soul (NEW Soul) Program

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eating Behavior; Nutrition, Healthy
• Intervention / Treatment: Behavioral: Plant-based diet; Other: Voucher only

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29228
      • Mimsy's Restaurant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-identify as African American
• Be between the ages of 18-65 years
• Body Mass Index between 25- 49.9 kg/m2
• Able to travel to restaurant for classes
• Be able to attend all monitoring and weekly class visits
• Be willing to be randomized to either group

Exclusion Criteria:

• Currently following a plant-based diet
• Diagnosed with diabetes that is controlled by medication
• Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
• Under the age of 18 years old
• Over the age of 65 years old
• Currently participating in a weight loss program
• Has lost more than 10 pounds in the past 6 months
• Potential eating disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Plant-based diet; Participants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant.
Active Comparator: Control; 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.	Other: Voucher only; Participants will receive vouchers to a local restaurant. Participants will not attend nutrition classes but will receive a class at the end of the 12-week study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight	Changes in body weight in kilograms	3-months
Changes in diet quality	Changes in dietary quality as assessed by the Healthy Eating Index	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	The investigators will assess the costs between delivering the in-person intervention plus voucher vs. voucher-only with the outcome of cost per change in participant body weight, healthy eating index score, and quality adjusted life year (QALY). The cost-effectiveness evaluation will also include estimating costs of the intervention itself (e.g., training, delivery, infrastructure).	3-months
Implementation	Implementation will be assessed using qualitative data collection with participants via focus groups and restaurant staff leading the intervention via in-depth interviews.	3-months

Collaborators and Investigators

• Sponsor: University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Behavior, Animal; Feeding Behavior; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, Plant-Based
• Other Study ID Numbers: Pro00116789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request, data will be shared with other researchers. Data will not be publicly available to protect participant confidentiality. The informed consent document will include information that de-identified data may potentially be shared with other researchers.
• IPD Sharing Time Frame: Upon reasonable request, participant data will be shared with other researchers.
• IPD Sharing Access Criteria: If granted, a password protected file with de-identified data of participants will be shared with other researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No