NCT03565718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

June 4, 2018

Last Update Submit

January 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dietary acceptability using the Food Acceptability Questionnaire

    Changes in acceptability of plant-based diets via a validated questionnaire

    Baseline and three weeks

Secondary Outcomes (2)

  • Body weight using a digital scale

    Baseline and three weeks

  • Perceptions of Plant-based diets using the Perceived Barriers and Benefits Questionnaire

    Baseline and three weeks

Study Arms (2)

Standard Group

ACTIVE COMPARATOR

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

Restaurant Group

EXPERIMENTAL

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

Interventions

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.

Restaurant Group

Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to grocery stores.

Standard Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Study Officials

  • Brie Turner-McGrievy

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 21, 2018

Study Start

June 1, 2018

Primary Completion

December 30, 2018

Study Completion

January 21, 2019

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations