Nutritious Eating With Soul Dissemination and Implementation

NCT05659966 | Active Not Recruiting

• 1 other identifier: Pro00116789
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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

Eating Behavior; Nutrition, Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Cost-effectiveness

  3-months

• Implementation

  3-months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Plant-based diet BEHAVIORAL

Participants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant.

Intervention

Voucher only OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

Mimsy's Restaurant

Columbia, South Carolina, 29228, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: April 3, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon reasonable request, participant data will be shared with other researchers.
• Access Criteria: If granted, a password protected file with de-identified data of participants will be shared with other researchers.

Locations

US (1)