Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06266533
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2024-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to a conventional nutrition education or an arts-based education group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultra-Processed Food Knowledge', 'timeFrame': '60 minutes', 'description': 'Participants will classify pictures of foods as ultra-processed or whole foods (adapted from Sarmiento-Santos, cited below) and as healthy or unhealthy. on a Pre and post-ultra-processed food knowledge questionnaire. Both sets of questions are yes or no categorical questions.'}, {'measure': 'Environmental assessment of ultra-processed food', 'timeFrame': '6 months', 'description': "Participant photographs of the local food environment. At two time points (pre and post educational intervention) participants will take photographs of the local food environment including grocery stores, restaurant menus, etc. The purpose of this is to learn from participants about how they perceive the local kids' food environment and if they observe differences after the intervention. Photo elicitation techniques will be used during a series of focus groups for participants to discuss the photographs they took. These data will be analyzed using a layered analysis of the photographs (appraisal, discussion with participant who took the photo, cross-photo comparison, and interpretation) pre and post educational intervention, and thematic analysis of the focus group transcripts."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Selection', 'Environmental Exposure']}, 'referencesModule': {'references': [{'pmid': '35564081', 'type': 'BACKGROUND', 'citation': "Sarmiento-Santos J, Souza MBN, Araujo LS, Pion JMV, Carvalho RA, Vanin FM. Consumers' Understanding of Ultra-Processed Foods. Foods. 2022 May 7;11(9):1359. doi: 10.3390/foods11091359."}, {'pmid': '31850537', 'type': 'BACKGROUND', 'citation': 'Andreassen P, Christensen MK, Moller JE. Focused ethnography as an approach in medical education research. Med Educ. 2020 Apr;54(4):296-302. doi: 10.1111/medu.14045. Epub 2020 Feb 16.'}, {'pmid': '25326092', 'type': 'BACKGROUND', 'citation': 'Braun V, Clarke V. What can "thematic analysis" offer health and wellbeing researchers? Int J Qual Stud Health Well-being. 2014 Oct 16;9:26152. doi: 10.3402/qhw.v9.26152. eCollection 2014. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food.', 'detailedDescription': "1. At baseline, describe how mothers of preschool-age children characterize food for children in their home and local environment and describe their knowledge of ultra-processed food.\n2. To test different ways of providing nutrition education for increasing knowledge about children's nutrition and ultra-processed foods. Hypothesis: Both groups will correctly identify more ultra-processed foods post-education.\n3. To learn in depth from mothers of preschool children about their perceptions of the food environmental culture (markets, advertising, health messaging, community norms, cultural norms, social norms) in Newark, NJ, through a series of focus group discussions about the mothers' photographs of the local food environment pre and post project."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-representation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* African American or Black or bi-racial or multi-racial African American and Black mothers\n* \\>18 years\n* Female\n* Legal guardian of a preschool-age child (3-5 years) participating in the Leaguers, Inc.\n\nHead Start programming.\n\nExclusion Criteria:\n\n* Spanish-speaking\n* Other racial and ethnic groups\n* Fathers'}, 'identificationModule': {'nctId': 'NCT06266533', 'briefTitle': 'Dismantling the U.S. Social Norm of the "Kids\' Food" Archetype (REACH Project)', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Dismantling the U.S. Social Norm of the "Kids\' Food" Archetype That Includes Ultra-processed Foods Such as Chicken Nuggets and Fries in the Newark, NJ Community', 'orgStudyIdInfo': {'id': 'Pro2023002473'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Nutrition Education', 'description': 'Conventional nutrition education', 'interventionNames': ['Behavioral: Conventional Ultra-processed Food Nutrition Education']}, {'type': 'EXPERIMENTAL', 'label': 'Arts-based Nutrition Education', 'description': 'Arts-based nutrition education video production', 'interventionNames': ['Behavioral: Arts-based Ultra-processed Food Nutrition Education']}], 'interventions': [{'name': 'Conventional Ultra-processed Food Nutrition Education', 'type': 'BEHAVIORAL', 'description': 'The participants will receive a conventional nutrition education session with slides, flyers/handouts, and a lecture with discussion.', 'armGroupLabels': ['Conventional Nutrition Education']}, {'name': 'Arts-based Ultra-processed Food Nutrition Education', 'type': 'BEHAVIORAL', 'description': 'The participants will receive an arts-based nutrition education session with video, animation, music, and discussion.', 'armGroupLabels': ['Arts-based Nutrition Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Leaguers Inc. Head Start', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Pamela Rothpletz-Puglia, EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pamela Rothpletz-Puglia, EdD, RD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}