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The Plant-Based and Soul-Full Study (PASS) (PASS)

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ClinicalTrials.gov Identifier: NCT03565718
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : November 12, 2018
Sponsor:
Collaborator:
Academy of Nutrition and Dietetics
Information provided by (Responsible Party):
University of South Carolina

Brief Summary:
The goal of this study is to examine if exposure to vegan soul food restaurants can increase African American adults' perceived benefits of consuming plant-based foods more so than standard guidelines. Although the health benefits of vegan diets are well documented, many people are reluctant to commit to a vegan diet long term. Various issues like food preparation, a lack of social support, or other barriers are often mentioned as reasons why people can't be vegan. This study will (1) find out if short term exposure (i.e. 3 weeks) to culturally tailored curriculum focusing on the health benefits of consuming plant-based foods increases African American adults' perceptions of adopting a vegan diet. And (2) if eating out a few times a week at vegan soul food restaurants can further increase African American adults' perceived benefits of a vegan than having to prepare all meals at home.

Condition or disease Intervention/treatment Phase
Dietary Modification Behavioral: Dietary Intervention: Restaurant Behavioral: Dietary Intervention: Standard/Grocery Not Applicable

Detailed Description:

The goal of this study is to examine if exposure to vegan soul food restaurants can increase African American adults' perceived benefits of consuming plant-based foods more so than standard guidelines. Although the health benefits of vegan diets are well documented, many people are reluctant to commit to a vegan diet long term. Various issues like food preparation, a lack of social support, or other barriers are often mentioned as reasons why people can't be vegan. This study will (1) find out if short term exposure (i.e. 3 weeks) to culturally tailored curriculum focusing on the health benefits of consuming plant-based foods increases African American adults' perceptions of adopting a vegan diet. And (2) if eating out a few times a week at vegan soul food restaurants can further increase African American adults' perceived benefits of a vegan than having to prepare all meals at home.

Study participants will receive counseling and informational materials from a trained research assistant to follow a vegan diet for 3 weeks. Participants will be randomly assigned to either a standard group or a restaurant group. The standard group will receive gift cards to shop at local super markets. The restaurant group will receive gift cards to eat out a few times a week at local vegan soul food restaurants. Changes in individuals' perceived benefits and barriers to consuming plant-based foods will be assessed with a validated survey at baseline and at the end of the 3 week period.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Plant-Based and Soul-Full Study: Increasing African American Adults' Perceived Benefits of Consuming Plant-Based Foods
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Group
Participants in this group will receive counseling, informational materials, and recipes for following a vegan diet. Participants in this group will receive gift cards to go shopping at their local supermarkets and follow the diet for 3 weeks. At the end of the 3 week period each participant will have a follow-up meeting and provide feedback to the study personnel. The Dietary Intervention: Standard/Grocery includes intervention meetings and dietary counseling.
Behavioral: Dietary Intervention: Standard/Grocery
Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to grocery stores.

Experimental: Restaurant Group

Participants in this group will receive counseling, informational materials, and recipes for following a vegan diet. Participants in this group will receive gift cards to go and eat out a few times a week at local vegan soul food restaurants and follow the diet for 3 weeks. At the end of the 3 week period each participant will have a follow-up meeting and provide feedback to the study personnel.

The Dietary Intervention: Restaurant condition includes intervention meetings and dietary counseling.

Behavioral: Dietary Intervention: Restaurant
Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to local vegan soul food restaurants.




Primary Outcome Measures :
  1. Dietary acceptability using the Food Acceptability Questionnaire [ Time Frame: Baseline and three weeks ]
    Changes in acceptability of plant-based diets via a validated questionnaire


Secondary Outcome Measures :
  1. Body weight using a digital scale [ Time Frame: Baseline and three weeks ]
    Body weight assess objectively via calibrated digital scale.

  2. Perceptions of Plant-based diets using the Perceived Barriers and Benefits Questionnaire [ Time Frame: Baseline and three weeks ]
    Changes in perceptions of plant-based diets via a validated questionnaire



Information from the National Library of Medicine

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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
  • Be between the ages of 18-65 years
  • Live in the Columbia, SC/Midlands area
  • Be able to attend all meetings with the study coordinator
  • Be willing to be randomized to either condition

Exclusion Criteria:

  • Currently following a vegan diet
  • Under the age of 18 years old
  • Over the age of 65 years old
  • Not willing to attend meetings with the study coordinator
  • Not willing to be randomized to either condition

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): NCT03565718


Contacts
Contact: Brie Turner-McGrievy 8037773932 brie@sc.edu

Locations
United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Contact: Gabrielle Turner-McGrievy, PhD, MS, RD    803-777-3932    brie@sc.edu   
Sponsors and Collaborators
University of South Carolina
Academy of Nutrition and Dietetics
Investigators
Principal Investigator: Brie Turner-McGrievy University of Southern California

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT03565718     History of Changes
Other Study ID Numbers: Pro00076585
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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