Nutritious Eating With Soul at Rare Variety Cafe

Obesity Clinical Trial

— NEWSoul@RV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513769
• Other study ID #: Pro00100991
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Vegan diet
Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	Assess changes in body weight	0, 3, and 12 months