Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03565718
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2018-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Plant-Based and Soul-Full Study (PASS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary acceptability using the Food Acceptability Questionnaire', 'timeFrame': 'Baseline and three weeks', 'description': 'Changes in acceptability of plant-based diets via a validated questionnaire'}], 'secondaryOutcomes': [{'measure': 'Body weight using a digital scale', 'timeFrame': 'Baseline and three weeks', 'description': 'Body weight assess objectively via calibrated digital scale.'}, {'measure': 'Perceptions of Plant-based diets using the Perceived Barriers and Benefits Questionnaire', 'timeFrame': 'Baseline and three weeks', 'description': 'Changes in perceptions of plant-based diets via a validated questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Modification']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nStudy 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identify as African American\n* Be between the ages of 18-65 years\n* Live in the Columbia, SC/Midlands area\n* Be able to attend all meetings with the study coordinator\n* Be willing to be randomized to either condition\n\nExclusion Criteria:\n\n* Currently following a vegan diet\n* Under the age of 18 years old\n* Over the age of 65 years old\n* Not willing to attend meetings with the study coordinator\n* Not willing to be randomized to either condition'}, 'identificationModule': {'nctId': 'NCT03565718', 'acronym': 'PASS', 'briefTitle': 'The Plant-Based and Soul-Full Study (PASS)', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': "The Plant-Based and Soul-Full Study: Increasing African American Adults' Perceived Benefits of Consuming Plant-Based Foods", 'orgStudyIdInfo': {'id': 'Pro00076585'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Group', 'description': '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.', 'interventionNames': ['Behavioral: Dietary Intervention: Standard/Grocery']}, {'type': 'EXPERIMENTAL', 'label': 'Restaurant Group', 'description': '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.\n\nThe Dietary Intervention: Restaurant condition includes intervention meetings and dietary counseling.', 'interventionNames': ['Behavioral: Dietary Intervention: Restaurant']}], 'interventions': [{'name': 'Dietary Intervention: Restaurant', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Restaurant Group']}, {'name': 'Dietary Intervention: Standard/Grocery', 'type': 'BEHAVIORAL', 'description': 'Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to grocery stores.', 'armGroupLabels': ['Standard Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Brie Turner-McGrievy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academy of Nutrition and Dietetics', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brie Turner-McGrievy', 'investigatorAffiliation': 'University of South Carolina'}}}}