Viewing Study NCT04513769


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Study NCT ID: NCT04513769
Status: COMPLETED
Last Update Posted: 2022-05-17
First Post: 2020-08-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Nutritious Eating With Soul at Rare Variety Cafe
Sponsor: University of South Carolina
Organization:

Study Overview

Official Title: Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation
Status: COMPLETED
Status Verified Date: 2022-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: NEWSoul@RV
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: