Nutritious Eating With Soul at Rare Variety Cafe (NEWSoul@RV)

Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation

To date, few dissemination and implementation (D&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims:

Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant.

Aim 2: Assess resource use and cost associated with a train-the-trainer D&I approach in a restaurant setting.

Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months).

Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Vegan diet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• self-identify as African American
• between 18-65 years old
• be free on meeting night (Tuesday at 6PM)
• be free of eating disorder
• be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
• willing to travel weekly to Rare Variety Café

Exclusion Criteria:

• currently following a plant-based/vegan diet
• have a body mass index of under 25 or over 49.9 kg/m2
• currently on medication for diabetes
• women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
• currently participating in a weight loss program or taking weight loss medications
• recent weight loss (>10lbs in the last 6 months)
• living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina
• currently in the NEW Soul study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study participants; This is a single-arm study so all participants receive the same intervention.	Behavioral: Vegan diet; Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	Assess changes in body weight	0, 3, and 12 months

Collaborators and Investigators

• Sponsor: University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Pro00100991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No