Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-29 @ 11:12 AM
Study NCT ID:
NCT04513769
Status:
COMPLETED
Last Update Posted:
2022-05-17
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritious Eating With Soul at Rare Variety Cafe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067269', 'term': 'Diet, Vegan'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': '0, 3, and 12 months', 'description': 'Assess changes in body weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '36689305', 'type': 'DERIVED', 'citation': 'Bernhart JA, Turner-McGrievy GM, Wilson MJ, Sentman C, Wilcox S, Rudisill C. NEW Soul in the neighborhood-reach and effectiveness of a dissemination and implementation feasibility study. Transl Behav Med. 2023 Apr 3;13(3):123-131. doi: 10.1093/tbm/ibac080.'}]}, 'descriptionModule': {'briefSummary': "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:\n\nAim 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.\n\nAim 2: Assess resource use and cost associated with a train-the-trainer D\\&I approach in a restaurant setting.\n\nAim 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).\n\nAim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul."}, '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* between 18-65 years old\n* be free on meeting night (Tuesday at 6PM)\n* be free of eating disorder\n* be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy\n* willing to travel weekly to Rare Variety Café\n\nExclusion Criteria:\n\n* currently following a plant-based/vegan diet\n* have a body mass index of under 25 or over 49.9 kg/m2\n* currently on medication for diabetes\n* women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)\n* currently participating in a weight loss program or taking weight loss medications\n* recent weight loss (\\>10lbs in the last 6 months)\n* living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina\n* currently in the NEW Soul study'}, 'identificationModule': {'nctId': 'NCT04513769', 'acronym': 'NEWSoul@RV', 'briefTitle': 'Nutritious Eating With Soul at Rare Variety Cafe', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Nutritious Eating With Soul at Rare Variety Cafe: Local Dissemination and Implementation', 'orgStudyIdInfo': {'id': 'Pro00100991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study participants', 'description': 'This is a single-arm study so all participants receive the same intervention.', 'interventionNames': ['Behavioral: Vegan diet']}], 'interventions': [{'name': 'Vegan diet', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant', 'armGroupLabels': ['Study participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'John Bernhart', 'investigatorAffiliation': 'University of South Carolina'}}}}