Nutritious Eating With Soul at Rare Variety Cafe | NCT04513769

Studies
Nutritious Eating With Soul at Rare Variety Cafe

NCT04513769

Sponsor

University of South Carolina

Status

Completed

Last Update Posted

May 17, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Vegan diet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 8, 2020Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Aug 11, 2020

First Submission Date that Met QC Criteria

Aug 11, 2020

First Posted Date

Aug 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study participants	Experimental	This is a single-arm study so all participants receive the same intervention.	Behavioral: Vegan diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vegan diet	Behavioral	Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant	Study participants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of South Carolina		Columbia	South Carolina	29208	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36689305	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D014676	Diet, Vegetarian
D000095500	Diet, Plant-Based
D004035	Diet Therapy
D044623	Nutrition Therapy