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Nutritious Eating With Soul at Rare Variety Cafe (NEWSoul@RV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04513769
Recruitment Status : Active, not recruiting
First Posted : August 14, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
John Bernhart, University of South Carolina

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : September 8, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. body weight [ Time Frame: 0, 3, and 12 months ]
    Assess changes in body weight


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513769


Locations
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United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
More Information
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Responsible Party: John Bernhart, Principal Investigator, University of South Carolina
ClinicalTrials.gov Identifier: NCT04513769    
Other Study ID Numbers: Pro00100991
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No