Nutritious Eating With Soul at Rare Variety Cafe

NCT04513769 | Completed

• 1 other identifier: Pro00100991
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• body weight

  Assess changes in body weight

  0, 3, and 12 months

Study Arms (1)

Study participants

EXPERIMENTAL

This is a single-arm study so all participants receive the same intervention.

Behavioral: Vegan diet

Interventions

Vegan diet BEHAVIORAL

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

Study participants

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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

• Bernhart JA, Turner-McGrievy GM, Wilson MJ, Sentman C, Wilcox S, Rudisill C. NEW Soul in the neighborhood-reach and effectiveness of a dissemination and implementation feasibility study. Transl Behav Med. 2023 Apr 3;13(3):123-131. doi: 10.1093/tbm/ibac080.

  PMID: 36689305 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: September 8, 2020
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)