NCT05659966

Nutritious Eating With Soul Dissemination and Implementation

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Nutrition, Healthy
• Eating Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Plant-based diet	Participants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant.
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.

Timeline

• Start date: 2023-04-03
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2022-12-21
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States