NEWSoul@RV: Nutritious Eating With Soul at Rare Variety Cafe

• Sponsor: University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT04513769
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.7
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Vegan diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation
• Actual Study Start Date: Sep 8, 2020
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Apr 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. body weight [0, 3, and 12 months]

   Assess changes in body weight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Carolina	Columbia	South Carolina	United States	29208

Sponsors and Collaborators

• University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Bernhart, Principal Investigator, University of South Carolina
• ClinicalTrials.gov Identifier: NCT04513769
• Other Study ID Numbers: Pro00100991
• First Posted: Aug 14, 2020
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 17, 2022