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ACTIVE NOT RECRUITING
NCT05659966
NA

Nutritious Eating With Soul Dissemination and Implementation

Sponsor: University of South Carolina

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2023-04-03

Completion Date

2027-03-31

Last Updated

2025-12-31

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Mimsy's Restaurant

Columbia, South Carolina, United States