- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03565718
The Plant-Based and Soul-Full Study (PASS) (PASS)
The Plant-Based and Soul-Full Study: Increasing African American Adults' Perceived Benefits of Consuming Plant-Based Foods
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary acceptability using the Food Acceptability Questionnaire
Time Frame: Baseline and three weeks
|
Changes in acceptability of plant-based diets via a validated questionnaire
|
Baseline and three weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight using a digital scale
Time Frame: Baseline and three weeks
|
Body weight assess objectively via calibrated digital scale.
|
Baseline and three weeks
|
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
|
Baseline and three weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brie Turner-McGrievy, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00076585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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