Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT05659966
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritious Eating with Soul Dissemination and Implementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-25', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-13', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body weight', 'timeFrame': '3-months', 'description': 'Changes in body weight in kilograms'}, {'measure': 'Changes in diet quality', 'timeFrame': '3-months', 'description': 'Changes in dietary quality as assessed by the Healthy Eating Index'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': '3-months', 'description': 'The investigators will assess the costs between delivering the in-person intervention plus voucher vs. voucher-only with the outcome of cost per change in participant body weight, healthy eating index score, and quality adjusted life year (QALY). The cost-effectiveness evaluation will also include estimating costs of the intervention itself (e.g., training, delivery, infrastructure).'}, {'measure': 'Implementation', 'timeFrame': '3-months', 'description': 'Implementation will be assessed using qualitative data collection with participants via focus groups and restaurant staff leading the intervention via in-depth interviews.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrition, Healthy', 'Eating Behavior']}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and implementation of community-delivered, 3-month NEW Soul program among participants (N=228).\n\nUsing a randomized design, the investigators will assess effectiveness of two delivery approaches: (1) In-person, live weekly classes with restaurant vouchers (intervention) or (2) restaurant voucher-only (active control).\n\nThe investigators will also conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher-only with the outcome of cost/change in weight, healthy eating index, and quality adjusted life year.\n\nLastly, the investigators will examine the implementation of the NEW Soul study with participants and intervention staff.'}, '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* Body Mass Index between 25- 49.9 kg/m2\n* Able to travel to restaurant for classes\n* Be able to attend all monitoring and weekly class visits\n* Be willing to be randomized to either group\n\nExclusion Criteria:\n\n* Currently following a plant-based diet\n* Diagnosed with diabetes that is controlled by medication\n* Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)\n* Under the age of 18 years old\n* Over the age of 65 years old\n* Currently participating in a weight loss program\n* Has lost more than 10 pounds in the past 6 months\n* Potential eating disorder'}, 'identificationModule': {'nctId': 'NCT05659966', 'briefTitle': 'Nutritious Eating with Soul Dissemination and Implementation', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'NEW Soul D&I: Expanding the Reach of the Nutritious Eating with Soul (NEW Soul) Program', 'orgStudyIdInfo': {'id': 'Pro00116789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention condition participants will be instructed to follow a plant-based diet. The intervention participants will receive weekly group classes for 3 months at a local restaurant and will receive guidance on how to choose foods to meet their nutrient needs that fit within the vegan diet. The intervention participants will receive a voucher each week for a free plant-based meal at the restaurant.', 'interventionNames': ['Behavioral: Plant-based diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants in the active control condition will receive meal vouchers to the restaurant. The active control condition participants will not receive any instruction to follow a particular diet or support. Participants in this condition will receive all intervention material and attend a class at the end of the study to learn about the intervention diet.', 'interventionNames': ['Other: Voucher only']}], 'interventions': [{'name': 'Plant-based diet', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a behavioral intervention on a plant-based diet in partnership with a local restaurant.', 'armGroupLabels': ['Intervention']}, {'name': 'Voucher only', 'type': 'OTHER', 'description': 'Participants will receive vouchers to a local restaurant. Participants will not attend nutrition classes but will receive a class at the end of the 12-week study.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29228', 'city': 'Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Bernhart, PhD', 'role': 'CONTACT', 'email': 'bernhaj@email.sc.edu', 'phone': '803-576-5810'}], 'facility': "Mimsy's Restaurant", 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'centralContacts': [{'name': 'Gabrielle M Turner-McGrievy, PhD', 'role': 'CONTACT', 'email': 'mcgrievy@mailbox.sc.edu', 'phone': '803-777-3932'}, {'name': 'John A Bernhart, PhD', 'role': 'CONTACT', 'email': 'bernhaj@email.sc.edu', 'phone': '803-576-5810'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Upon reasonable request, participant data will be shared with other researchers.', 'ipdSharing': 'YES', 'description': 'Upon reasonable request, data will be shared with other researchers. Data will not be publicly available to protect participant confidentiality. The informed consent document will include information that de-identified data may potentially be shared with other researchers.', 'accessCriteria': 'If granted, a password protected file with de-identified data of participants will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Brie Turner-McGrievy', 'investigatorAffiliation': 'University of South Carolina'}}}}